U.K. General Medical Council Rules Wakefield & Co. "Dishonest," "Irresponsible" · 12 days ago

Today, the General Medical Council (GMC), which registers doctors to practice medicine in the U.K., issued a decision in its inquiry into the professional conduct of Dr. Andrew Wakefield and his colleagues Dr. John Walker-Smith, and Dr. Simon Murch, co-authors of a study which concluded that a causal connection exists between the measles-mumps-rubella vaccine and autism.

The GMC determined that the three doctors failed to act in the best interests of the autistic children under their care, that Dr. Wakefield was dishonest, misleading and irresponsible in his descriptions of research, and that the findings of the investigation “would not be insufficient to support a finding of serious professional misconduct” against all three doctors.

The study at the center of the inquiry was published in The Lancet in 1998. Six years later, ten of its thirteen co-authors retracted their conclusions in that study.

Further background can be found on the website of journalist Brian Deer, whose in-depth investigation of Wakefield and his research alleged numerous irregularities — including his failure to disclose his role in litigation against vaccine manufacturers, failure to disclose pending vaccine patents, performance of needless, invasive medical procedures on autistic children, and misrepresentation of data — and ultimately led to the disciplinary hearings.

On 7 April 2010, the GMC Disciplinary Panel will consider whether the conduct described in the decision warrants professional sanctions, including revocation of Dr. Wakefield’s, Dr. Walker-Smith’s or Dr. Murch’s license to practice medicine in the U.K. Dr. Wakefield now resides in Texas, and although not licensed to practice medicine in the United States, is the Executive Director of Thoughtful House, which provides medical care to autistic children.

The following passages are excerpted from the GMC decision.


On the responsibilities of a physician/researcher:

[A]mongst the responsibilities of a Responsible Consultant, is the requirement to conduct research within ethical constraints, and report it responsibly, accurately and fairly. At no stage should a doctor take any action that is contrary to the clinical interests of the patient involved.

On Dr. Wakefield’s, Dr. Walker-Smith’s and Dr. Murch’s authorization of hospital admission and medical procedures on children for whom they were not clinically indicated, and commencement of research for which no ethical approval had been obtained:

Child 1 underwent a colonoscopy, MRI scan of his brain, an EEG and a variety of blood and urine tests. These were some of the investigations listed in the programme of the project. He was further admitted on 23 October 1996 for further investigations regarding the “etiology of the autism”, again for no obvious clinical gastro-intestinal reasons. During this admission, Child 1 underwent a barium meal and follow-through and a lumbar puncture. These were also the investigations listed in the programme of the project. The Panel has concluded that Child 1 underwent a programme of investigations for research purposes and for which there was no Ethics Committee approval. (p. 16)

You [Dr. Murch] attempted to carry out a colonoscopy on Child 1 when such an investigation was not clinically indicated… You wrote in your colonoscopy report dated 22 July 1996 that the child’s history is “disintegrative disorder” and noted that the letter to the child’s GP from Professor Walker-Smith concluded the child had features of toddler’s diarrhoea. The Panel concluded that these were not clinical indications to undergo a colonoscopy… You attempted to carry out a colonoscopy on Child 1 when such an investigation was not clinically indicated. (pp. 120, 125)

[T]here is no evidence in Child 3’s clinical notes to indicate that a lumbar puncture was required. Experts on both sides… both considered that such a test was not clinically indicated… The Panel is persuaded by the letters written by [Dr. Walker-Smith] at the time, to Child 3’s paediatric neurologist, his school doctor and his GP, that you did conclude there was no evidence of bowel inflammation on routine blood results but nevertheless you decided to admit Child 3. In particular, the Panel noted the wording of the letter dated 18 July 1996 to the paediatric neurologist: “…the initial blood screens for bowel inflammation were negative, however Dr Wakefield is of the opinion that subtle changes in relation to inflammation may be present… and we have arranged (Child 3’s) admission”. (p. 68)

The Panel is satisfied that… you [Dr. Wakefield] exposed Child 4 to an unnecessary test. (p. 24)

You [Dr. Wakefield] ordered the neurophysiological investigations [on Child 7] without having requisite paediatric qualifications and writing an incorrect diagnosis on the investigation form. (p. 40)

Child 8 was admitted to the Royal Free Hospital on 19 January 1997, without prior outpatient assessment. (p. 37)

The Panel concluded that subjecting the child [Child JS] to a colonoscopy was not clinically indicated as his main presentation was behavioural difficulties and you [Dr. Walker-Smith] accepted his GI symptoms were “rather minor… In your evidence to the Panel you accepted that you did “lower the threshold” in relation to this child… The Panel concluded that these findings, which include those of your irresponsible conduct and not acting in the child’s best clinical interests in several instances, would not be insufficient to support a finding of serious professional misconduct. (p. 111)

On Dr. Wakefield’s taking of blood samples from guests at his son’s birthday party:

On a date unknown prior to 20 March 1999 at your son’s birthday party you… caused blood to be taken from a group of children to use for research purposes… [Y]ou showed a callous disregard for the distress and pain that you knew or ought to have known the children involved might suffer.. The Panel is satisfied by your evidence that the children were “paid for their discomfort”, which it concluded was evidence of a callous disregard. (54-55)

On Dr. Walker-Smith’s “parent-driven” testing and treatment recommendations:

The Panel was satisfied on the basis of your letter to his GP dated 21 June 1996, where you stated “…if (child 1’s mother) feels that is appropriate we could consider performing endoscopy and further assessments…” The Panel concluded that your reliance on her views that there was a link between autism and immunisation and bowel inflammation was inappropriate. (p. 67)

On Dr. Wakefield’s assertion that the definition of “conflict of interest” changed after publication of the Lancet study:

The Panel is satisfied that the concept of a conflict of interest, and the extension of this to the perception of a conflict of interest, was known in the scientific community in 1997. At that time the Lancet and other organisations had published guidance on the requirement for authors for recognising and declaring financial and other conflicts of interests, as well as the importance of declaring “potential”, “perceived” or “apparent” conflicts of interest. The Panel therefore rejects the proposition put forward by your Counsel that third party perceived conflicts of interest did not fall within the relevant definition at the time. (p. 44)

On Dr. Wakefield’s failure to disclose relevant information about the purpose and subjects of the Lancet study:

[T]he project reported in the Lancet paper was established with the purpose to investigate a postulated new syndrome and yet the Lancet paper did not describe this fact at all. Because you drafted and wrote the final version of the paper, and omitted correct information about the purpose of the study or the patient population, the Panel is satisfied that your conduct was irresponsible and dishonest. (p. 45)

On Dr. Wakefield’s assertion that his autistic subjects were “routine referrals” for whom invasive testing was medically indicated:

Having regard to its findings in relation to Child 1, 9, 5 and 10, namely that these children were admitted to undergo a programme of investigations for research purposes, and that they all lacked a history of gastrointestinal symptoms, the Panel is satisfied that these referrals did not constitute routine referrals to the gastroenterology department… In reaching its decision, the Panel concluded that your description of the referral process as “routine”, when it was not, was irresponsible and misleading and contrary to your duty as a senior author. (p. 46)

On Dr. Wakefield’s response to allegations of selection bias:

The Panel is persuaded by all the correspondence in the Lancet Journal volume 351 dated 2 May 1998 regarding a suggestion by correspondents to the Lancet that there was a biased selection of patients in the Lancet Paper of 28 February 1998, of which you were one of the senior authors. The Panel has found that your [published response] does not respond fully and accurately to the queries made by correspondents to the Lancet. The Panel is satisfied that the statement you made would be considered by ordinary standards of reasonable and honest people to be dishonest. Additionally, you knew that this statement omitted necessary and relevant information, such as the active role you played in the referral process, and the fact that the referral letters in four cases made no mention of any gastrointestinal symptoms and the fact that the investigations had been carried out… for research purposes. Therefore, the Panel is satisfied that your conduct in this regard was dishonest and irresponsible. (p. 47)

On Dr. Wakefield’s failure to disclose conflicts of interest to the editors of the Lancet:

…[T]he Panel is satisfied that your conduct in failing to disclose your involvement in the MMR litigation, your receipt of funding for part of [your research] from the Legal Aid Board and your involvement in the Patent, constituted disclosable interests. Your failure to disclose these to the Editor of The Lancet was contrary to your duties as a senior author of the Lancet paper. (p. 50)

On the administration of an unlicensed drug to a study subject:

The Panel noted that Child 10’s deterioration was not assessed by any clinician prior to being administered Transfer Factor. Therefore the Panel has concluded that Child 10 was given Transfer Factor for experimental reasons… Furthermore, an essential requirement of a doctor is to share information with colleagues in the ways that best serve patients’ interests. The Panel has noted the evidence that Child 10’s GP did not have any knowledge of any prescription of Transfer Factor other than that contained in a letter from the community paediatrician. The Panel is satisfied that you [Dr. Wakefield] did not inform the GP or arrange for someone else to do so. (pp. 52-53)

The Panel is persuaded that Child 10 was administered Transfer Factor by the weekly diary card completed by his mother, submitted to the Royal Free Hospital in January 1998 which states, “over Christmas and New Year we felt very optimistic about the apparent effect of Transfer Factor… is it possible that the dose now needs to be increased?”. The Panel concluded that you [Dr. Murch] caused the child to be administered with Transfer Factor on the basis of the letter of 23 July 1997 that you and Dr Wakefield wrote to the Dispensary Manager. You informed her that “we would like to start Child 10 …on measles-specific Transfer Factor and we are prepared to take full responsibility for the outcome of this treatment. The supplies of the drug are presently in our hands (Dr Wakefield).” … The Panel is persuaded that this was experimental treatment and not given for clinical reasons, because you had not seen or assessed the child before causing him to be administered with the unlicensed drug and you stated “we do not know whether the treatment will work” in your letter to the Dispensary manager of the pharmacy, dated 23 July 1997, jointly signed by you and Dr Wakefield. (p. 100)

Conclusion re Dr. Wakefield:

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. (p. 55)

Conclusion re Dr. Walker-Smith:

The Panel concluded that these findings, which include those of your irresponsible conduct and not acting in the child’s best clinical interests in several instances, would not be insufficient to support a finding of serious professional misconduct. (p. 111)

Conclusion re Dr. Murch:

The Panel concluded that these findings, which included Dr. Murch failing in his duty as a responsible consultant and in some cases, not acting in the best clinical interests of the children, would not be insufficient to support a finding of serious professional misconduct.

Waist Deep In The Autism Fundraising Hole · 132 days ago

An Update on the “Autism Spectrum Disorder Foundation” & Its Telemarketing Campaign

The Autism Spectrum Disorder Disorder Foundation (ASDF) — the subject of the report “Dialing for Autism Dollars,” published on this weblog in March 2009 — has filed its 2008 audit, tax return, revised telemarketing contracts, and fundraising campaign report with the North Carolina Secretary of State Charitable Solicitation Licensing Section. These documents reveal that the purportedly charitable organization, whose principals claim to provide educational services and financial aid to benefit autistic children and their families, is almost exclusively devoted to the begging business, and that ASDF is thousands of dollars in debt to the professional fundraising firms whose staff have been blanketing the United States with telephone solicitations since mid-2008.

As described in detail in “Dialing for Autism Dollars,” ASDF was incorporated in 2007, granted tax exemption shortly thereafter, and promptly commenced a nationwide telephone and direct mail fundraising campaign. Its founder and President — Schererville, Indiana resident Michael Slutsky — has acknowledged having no personal or professional experience or expertise in autism or disability services or advocacy; until early 2008, he was a wholesale distributor of candles and other fundraising supplies to churches, school groups and nonprofit organizations.

In 2008 — its first full year of operations — Mr. Slutsky’s newly-hatched “charity” received $370,082 in donations, incurred $370,858 in liabilities for telemarketing services, and incurred an additional $126,930 in liabilities for printing and mailing fundraising appeals. At the end of the year, the organization faced a $165,854 deficit, with $159,225 owed to fundraising consultants, and $14,678 to Mr. Slutsky himself.

ASDF’s expenditures on grants, donations and scholarships to directly benefit autistic children and families totaled $1,391 — $160 to subsidize one parent’s attendance at a workshop, $850 for a camp scholarship for one child, an $86 donation to the Autism Society of Oregon, and another $295 in unspecified grants and donations. These outlays represent less than 0.3% of the $370,082 in contributions received by the organization from the general public during 2008. In its audit, however, ASDF asserts that its telephone calls and direct mail packages help fulfill its charitable mission, and therefore allocates half of its fundraising costs — over $250,000 — to the “program services” category.

ASDF’s Direct Mail Package

The paper goods at the heart of ASDF’s “volunteer solicitation” campaign (reproduced in the images below and in a 4MB .pdf file) come packaged in a glossy envelope illustrated with photographs of a girl playing with a butterfly, and embellished with the words “Wings of Hope” and “Thank you for volunteering… Start your kit today and give hope to children with autism.” The envelope flap declares that “Every 20 minutes a child is diagnosed with autism,” and urges the recipient to open the package immediately.



The package contains two “assignment cards” with a computer-generated list of names, addresses and telephone numbers of fifteen of the recipient’s neighbors, and a list of “Early Signs and Red Flags for Infants and Toddlers at Risk for an Autism Spectrum Disorder.”


The package also contains fifteen blank white envelopes, fifteen blank green envelopes, and fifteen campaign letters.



The campaign letters inform the reader that one in 150 children are diagnosed with autism, and invite potential donors to

bring a candle of hope into that dark world by helping the Autism Spectrum Disorder Foundation today. By giving to the Wings of Hope Campaign, you can help us provide financial assistance to families in need, free Early Detection Kits, and scholarships to send children with autism to camp.


The recipient is instructed to hand-address each white envelope to the neighbors listed on their “assignment card,” and to self-address each green envelope; to personalize each campaign letter with a signature and a handwritten message; to stuff each white envelope with a campaign letter and a green return envelope; and to mail all fifteen envelopes with stamps purchased and donated by the recipient. The recipient is next instructed to record donations on the assignment card as they are received from neighbors; to follow up with a phone call to those who do not respond; to convert cash donations into a personal check made payable to the Autism Spectrum Disorder Foundation; and to mail off the donations and the completed assignment sheet in a large envelope provided in the package.

The large envelope is addressed to the “Autism Foundation Processing Center, P.O. Box 96730, Washington, D.C. 20090-6730” — a rented mailbox at the main post office in the nation’s capital, where neither the Autism Spectrum Disorder Foundation nor any “Autism Foundation” has an office, or is legally authorized to solicit funds. ASDF’s actual legal address in Everett, Washington, the name of the telemarketing firm hired to conduct ASDF’s fundraising campaign — InfoCision Management Corporation of Akron, Ohio — and a list of ASDF’s official filings with state regulatory agencies appear in small print on the back of the campaign letter. The small print also indicates that donations to ASDF may be used for far less specific purposes than those described in the campaign letter:

Funds donated to ASDF will be used to address any and all kinds of issues in assisting children with Autism and their families.


Completing the presentation, a slip of yellow paper reiterates the assertion that “Every 20 minutes a child is diagnosed with autism,” and urges the recipient to visit the organization’s website at www.myasdf.org/wingsofhope.

The only information about autism provided in the direct mail package is the list of “Early Signs and Red Flags” on the assignment sheet, and the recitation of the “one in 150” statistic in the campaign letter. Such sparse factual content notwithstanding, the note on “Accounting for Costs of Activities That Include Fundraising” accompanying ASDF’s audit asserts that:

[ASDF’s] direct mail campaigns share a dual purpose of fundraising and program services that call for the recipients to help fulfill the ASDF’s mission. Given the dual nature of the mail campaigns, the ASDF has adopted a policy to split the costs of the direct mail campaign 50% to fundraising and 50% to program services.

ASDF’s “Early Detection Kit”

The “Early Detection Kit” described in the fundraising appeal consists of a cover letter addressed to “individual[s] who work in the care industry,” a DVD and a growth chart listing “various developmental capabilities children should have throughout the first five years of life.” The list of milestones on the growth chart is appropriated word-for-word from the Child Development Informational Card published by the U.S. Centers for Disease Control, a resource widely distributed to physicians, educators, clinics, and social service providers. Whereas ASDF fails to cite the source of the list, the CDC gives proper attribution to Drs. Steven Shelov and Robert E. Hannerman, authors of the American Academy of Pediatrics guide, Caring for Your Baby and Young Child: Birth to Age 5, published by Bantam Books.

ASDF’s 2008 Audit

The following financial statements are reproduced from ASDF’s audit, prepared on July 14, 2009 by the St. Louis firm Swink Fiehler & Company P.C.

STATEMENT OF NET ASSETS AS OF DECEMBER 31, 2008

Assets  
Cash and cash equivalents $6,780
Funds held in escrow $1,349
Total assets $8,129
   
Liabilities and Net Assets  
Liabilities  
Accounts payable $157,518
Loans payable to Executive Director $14,678
Payroll liabilities $80
Wells Fargo checking overdraft $1,707
Total Liabilities $173,983
Net Assets  
Unrestricted net assets ($165,854)
Total Net Assets ($165,854)
Total Liabilities & Net Assets $8,129
 

(The notes to the financial statements describe the $14,678 in loans payable to Michael Slutsky as “non-interest bearing advances” that the foundation intends to repay, and indicate that ASDF “makes periodic payments as cash flow permits” — implying that such advances and repayments occur on a regular basis.)

STATEMENT OF ACTIVITIES AS OF DECEMBER 31, 2008

Revenue  
Contributions $370,082
Total revenue $370,082
   
Expenses  
Program services $250,285
Management and general $25,384
Fundraising $255,913
Total expenses $531,583
   
Decrease in net assets ($161,501)
   
Unrestricted Net Assets, Beginning of Year ($4,353)
   
Unrestricted Net Assets, End of year ($165,854)
 

(As itemized in the “Statement of Functional Expenses” that follows, and explained in the note on “Accounting for Costs of Activities That Include Fundraising” cited above, $248,894 of the $250,285 categorized under “Program Services” represents half of the cost of the telemarketing and direct mail campaign.)

STATEMENT OF FUNCTIONAL EXPENSES FOR THE YEAR ENDING DECEMBER 31, 2008

  Program Services Management and General Fundraising Expense Total Expenses
         
Grants $341     $341
Compensation of officers   $585   $585
Payroll taxes   $69   $69
Professional fees – legal and accounting   $16,666   $16,666
Advertising and promotion   $1,689 $1,689 $3,378
Office expenses   $795   $795
Travel   $898 $898 $1,796
Bank and merchant service fee   $2,221 $2,221 $4,442
Donations $200     $200
Printed materials and fulfillment $38,515   $38,515 $77,030
Professional fees – telemarketing services $185,429   $185,429 $370,858
Postage and delivery $24,950 $250 $24,950 $50,150
Registration fees   $801 $800 $1,601
Scholarships $850     $850
Telecommunications ________ $1,411 $1411 $2,822
         
TOTAL $250,825 $25,385 $255,913 $531,583

(Grants, donations and scholarships are not itemized in ASDF’s financial statements, but are partially described in its tax return.)

ASDF’s 2008 Tax Return

The Form 990 informational return filed by the Autism Spectrum Disorder Foundation with the Internal Revenue Service reports $370,082 in contributions and $271,348 in program expenses in 2008; $270,252 of the latter amount represents half of the cost of ASDF’s telemarketing and direct mail campaign. The remaining $1,096 is comprised of three grants made during the first two months of 2008: an $850 payment to Mount Hood Autism Camp, a $160 payment to Think Social Publishing, and an $86 donation to the Autism Society of Oregon Walkathon.

The 990 claims that ASDF President and Executive Director Michael Slutsky devoted 45 hours per week to the Foundation’s activities, but received no compensation whatsoever; and that Chief Financial Officer Janet Coyer toiled a noteworthy 75 hours per week on ASDF business for only $585 in annual salary. $387,533 in “professional fees” to consultants is reported, $279,506 of which consists of payments to InfoCision. The 990 provides no further detail regarding the remaining $108,027 in “professional fees,” and does not indicate whether any of these “professional fees” were paid either directly or indirectly to Mr. Slutsky or Ms. Coyer in lieu of salary.

In addition to identifying Mr. Slutsky and Ms. Coyer as Directors, the Board roster provided with the 990 names Everett, Washington school psychologist James Roan, and indicates that he received no compensation and devoted no time whatsoever to the organization. (In a March 2009 phone conversation, Mr. Roan claimed to have had no significant involvement with ASDF since early 2008, when he helped to develop its website.) Also named as a Director is Mrs. Helen Ignas, who has shared a residence with Mr. Slutsky and like Mr. Roan, devoted no time to the organization’s activities.

ASDF’s Telemarketing Contract With InfoCision

In March 2009, Mr. Slutsky and Ms. Coyer entered into a revised contract with InfoCision for ASDF’s telemarketing and direct mail fundraising campaign. Charges for phone calls, printed matter, postage, and other services remain roughly the same as in the original September 2008 contract; however, whereas the original contract included a “Breakeven Guarantee For Prospecting” ensuring that ASDF’s liability would not exceed the cost of the fundraising campaign, the revised contract paints a far less generous scenario:

3.1 Pay From Proceeds The parties agree that InfoCision [IMC] shall advance [ASDF] $3,000 per month. This amount shall first be paid from the proceeds fulfilled from donations accrued for all programs during the contract term. In the event the proceeds from all programs do not total $3,000, IMC will advance the amount of the shortage from its own funds. The $3,000 advancement will be added to the accumulating deficit on [ASDF]‘s account.

The remainder of proceeds from all programs will go to IMC to pay all fundraising costs irrespective of the program… Parties also agree that this schedule of payment will be adhered to on each individual campaign, until both parties are satisfied but in no event later than the time in which [ASDF]‘s deficit is eliminated.

In the event that there are not enough funds to pay all of the donor acquisition debt, IMC may at its sole discretion forgive the remainder of the donor acquisition debt…” (emphasis added)

The note on “Mail and Communication Campaigns” in the ASDF audit indicates that of the $157,870 in accounts payable to fundraising consultants at the close of 2008, only $24,164 stood to be forgiven if the campaigns fail to generate enough donations to cover costs.

InfoCision’s Fundraising Campaign Report

In June 2009, InfoCision filed a final accounting for the ASDF telemarketing campaign in North Carolina. According to this report, out of $14,943.25 in donations received from North Carolina citizens between October 15, 2008 and March 21, 2009, $14,898.95 was paid to InfoCision for calls, letters, postage, training, computer services, and shipping. $44.30 — 0.3% of the total amount raised in North Carolina — was ultimately received by the Autism Spectrum Disorder Foundation.

Associated Community Services Contract & Withdrawal

As previously discussed in “Dialing For Autism Dollars,” the Autism Spectrum Disorder Foundation has also retained Associated Community Services (ACS), a Southfield, Michigan for-profit firm that conducts telemarketing campaigns on behalf of nonprofit organizations. ACS’s fundraising campaign for the Knoxville-based Youth Development Fund has been the subject of investigation by the Tennessee Attorney General’s office; in August 2008, ACS was fined $100,000 by the Missouri Attorney General for harassing Missouri residents with rude, high-pressure telephone solicitations.

The contract between the Autism Spectrum Disorder Foundation and Associated Community Services names ACS as ASDF’s “exclusive sales agent and exclusive representative,” responsible for “locat[ing] telemarketing firms qualified to conduct campaigns” throughout the United States and Canada. The contract further reveals that ASDF has agreed to pay ACS 52% of gross proceeds resulting from the firm’s efforts, and that ASDF has also commissioned “an outside firm to collect the proceeds of solicitation, deposit same, and… account for all funds received through ACS’s efforts.” The identity of this “fundraising campaign finance manager” is not disclosed.

In June 2009, Associated Community Services formally withdrew its applications to raise funds in North Carolina for ASDF and for the unrelated Law Enforcement Education Program, and submitted an affidavit confirming that ACS had not solicited and would not solicit funds for either organization in that state. Although ACS President R. William Burland did not specify his reasons for the withdrawals, they occurred shortly after the Federal Trade Commission’s announcement of “Operation False Charity,” a crackdown on fraudulent charity telemarketers. At the same time, the Connecticut Attorney General announced the filing of a lawsuit against Associated Community Services alleging failure to comply with state regulations requiring disclosure of its status as a paid solicitor, and the South Carolina Attorney General publicized an ongoing investigation against the firm.

The North Carolina withdrawal notwithstanding, ASDF’s contract with ACS remains in effect through July 2010. Absent similar withdrawals in other states, it can be assumed that ACS will continue to raise funds on behalf of the Autism Spectrum Disorder Foundation everywhere it is legally permitted to do so.

Free Speech, Secrecy & Sunshine

In its 1988 decision in Riley v. American Federation of the Blind (108 S.Ct. 2667), the United States Supreme Court struck down North Carolina’s Charitable Solicitations Act, which defined the “reasonable fee” that a professional fundraiser could charge a nonprofit organization, and required fundraisers to disclose to potential donors, before appealing for funds, the percentage of contributions collected during the previous twelve months that were actually turned over to the charity. The court held that such requirements represented unconstitutional infringements on freedom of speech, were “unduly burdensome,” were likely to hamper legitimate efforts to raise money for charitable purposes, and would inevitably discriminate against small or unpopular organizations. The American Federation of the Blind’s case was argued by Errol Copilevitz, whose firm represents the Autism Spectrum Disorder Foundation and a host of other nonprofit organizations engaged in telemarketing and direct mail fundraising.

While overruling a law that it described as “prophylactic, imprecise, and unduly burdensome,” the court acknowledged the need to prevent fraud on charities and potential donors by requiring tax-exempt organizations and their for-profit consultants to disclose the details of their financial relationships. The court suggested that, in order prevent fraud,

the State may itself publish the detailed financial disclosure forms it requires professional fundraisers to file. This procedure would communicate the desired information to the public…

The North Carolina Attorney General’s office took this advice to heart; the state now leads the way in making charitable solicitation filings readily available to the public on the Internet. In so doing, it subverts intentions such as those expressed in the contract between InfoCision and the Autism Spectrum Disorder Foundation:

10.2 Non-Disclosure of Relationship

[E]ach party agrees that it will not disclose either expressly or by implication the existence of this Agreement or the relationship created hereunder to any third party without the express written consent of the other party. Further… both parties agree to maintain complete confidence and secrecy with respect to the pricing, terms and conditions of this Agreement.

Evidently, Mr. Slutsky, Ms. Coyer and their fundraising consultants would prefer that the public remain unaware of the extent to which contributions to the Autism Spectrum Disorder Foundation enrich those who hold out the begging bowl to the caring, generous and unsuspecting public. The organization’s financial statements, contracts and regulatory filings, however, reveal the dollars-and-cents reality behind ASDF’s altruistic-sounding pleas for donations for the supposed benefit of “children and the families of children suffering autism spectrum disorder.” These documents paint a picture of a money-churning operation masquerading as a philanthropy, an “Autism Foundation” established and enabled by individuals with no experience or expertise in the field of developmental disabilities, who solicit donations at great expense with materials that provide minimal, already widely available information about autism — and who would like potential donors to believe that they are engaging in a primarily educational endeavor, rather than digging an ever-widening financial hole in the ground.

The following non-profit organizations provide education, recreation, respite and advocacy for autistic children, adults, their families, educators and care providers. Each and every one is worthy of support; none engages in telemarketing solicitation.

Asperger’s Association of New England (AANE)
ARC of King County, Washington
Autism National Committee
Autism Network International
Autism Society of America Foundation
Autism Society of Indiana
Autism Society of New Hampshire
Autism Society of North Carolina
Autism Society of Oregon
Autistic Self-Advocacy Network
Autistics.org
Provincial Autism Center

Many thanks to the reader who provided me with ASDF’s fundraising kit.

Federal Claims Court Dismisses Third MMR-Autism Appeal · 181 days ago

In a 59-page decision issued yesterday afternoon, August 11, Judge Margaret M. Sweeney of the United States Court of Federal Claims sustained the ruling of Special Master Denise K. Vowell dismissing the Vaccine Injury Compensation Program claim, Snyder v. U.S. Department of Health and Human Services (Case No. 01-162V) — the last of the three Omnibus Autism Proceeding test cases in which petitioners sought to establish that a combination of the MMR vaccine and thimerosal-containing vaccines, acting in concert, are capable of causing autism spectrum disorders.

Arguments raised in the Snyder appeal were virtually identical to those raised by the petitioners in Cedillo v. HHS and Hazlehurst v. HHS.

The decision includes an extensive discussion of the role of the special master in Vaccine Injury Compensation Program proceedings, elucidating the differences between VICP vaccine injury claims and conventional tort claims. Judge Sweeney herself served as a VICP special master from 2003-2005, and ruled on dozens of such cases.

From the decision:

[W]hen considering the provisions and legislative history of the Vaccine Act, the language of the Vaccine Rules, and the case law, one factor that has remained constant in the Vaccine Program is the necessary and important role of special masters in conducting proceedings and rendering decisions in Vaccine Act cases. The special masters have great leeway in how they conduct proceedings, including what evidence to consider and how to weigh that evidence, and their credibility determinations and fact-intensive conclusions are afforded great deference. However, this is not to suggest that the special masters are infallible and that their final decisions are sacrosanct. To be sure, the Court of Federal Claims on review, and the Federal Circuit on appeal, do not merely rubber stamp special master final decisions. Decisions from both courts demonstrate a willingness to reverse the decision of a special master when the special master has failed to adequately develop the record, failed to consider facts critical to the case, failed to give adequate consideration to a viable medical theory, or otherwise misapplied the law. Nevertheless, the law is settled that neither the Court of Federal Claims nor the Federal Circuit can substitute its judgment for that of the special master merely because it might have reached a different conclusion. Reversal is appropriate only when the special master’s decision is arbitrary, capricious, an abuse of discretion, or not in accordance with the law. (pp. 16-17)

[P]etitioners’ contention that they were required to prove their case to all three special masters lacks merit. Although all three special masters heard and considered the general causation evidence, they issued separate decisions applying that evidence to their respective test case. The special masters were free to reach different conclusions based on the same evidence. That all three reached the same conclusion – rejecting petitioners’ theory of causation – does not mean that petitioners were required to satisfy all three special masters. There is nothing in the record suggesting that the special masters were bound to speak with one voice. Nor can petitioners point to evidence that Special Master Vowell rendered her decision in consultation with the other two special masters. Rather, petitioners generally contend that their review of the three special masters’ decisions caused them to conclude that they had to prove their individual case to all three special masters. The court finds no evidence in the record to support this purported heightened burden. Moreover, the decision of the special masters to conduct the general causation hearing together, rather than require three separate hearings concerning the general causation issue with the resultant duplication of the time and resources of the OSM, petitioners, and respondent, hardly suggests fundamental unfairness. To the contrary, it reflects a common-sense, cost-saving approach to complex litigation. Accordingly, the use of a panel of three special masters to hear the general causation evidence was not arbitrary, capricious, an abuse of discretion, or contrary to law. (pp. 19-21)

Petitioners complain that the filing of Dr. Bustin’s “highly technical” reports from the U.K. MMR litigation “on the eve of trial” and the submission of Dr. Bustin’s “impossibly technical power-point [sic] presentation at the hearing” were “grossly unfair” because counsel for the Cedillo petitioners had “no time to review the documents, let alone prepare for crossexamination.” However, petitioners could not have been surprised that respondent would need to address the laboratory results from Unigenetics – evidence that the petitioners, not respondent, put in play. As is clear from the record and as they acknowledge in their motion for review, the Unigenetics test results were “the single-most critical issue in the case.”

…[I]t is clear to the court that petitioners have no basis to complain about the special master admitting Dr. Bustin’s expert reports into the record. It was not until February 2007 – when petitioners filed their expert reports – that respondent could have been aware that the test results from Unigenetics were crucial to petitioners’ theory of causation. Indeed, respondent did not actually become aware of the importance of the test results until March 2007 after he retained expert witnesses to review, analyze, and respond to petitioners’ expert reports. There is no question that respondent was not dilatory in obtaining as much information relevant to petitioners’ theory of causation as possible prior to the Cedillo hearing in June 2007. It would have been grossly unfair to respondent had he been hampered in his ability to counter petitioners’ theory of causation as a result of petitioners’ failure to fully explain their theory of causation until four months before hearing, especially in light of his due diligence. It is worth remembering that in Vaccine Program proceedings, petitioners have the burden of going forward, and only after petitioners have made a prima facie case does the burden of persuasion shift to respondent. Thus, without the formal discovery that is available in other civil litigation, it is not surprising that respondent in this case could not anticipate the precise nature of petitioners’ theory of causation and supporting testimony.

Moreover, as previously described, the special master afforded petitioners ample opportunity to respond to the contents of Dr. Bustin’s reports once the Cedillo hearing had concluded. She, along with the two other special masters, repeatedly queried petitioners about their efforts to obtain additional information from the U.K. MMR litigation, encouraged petitioners to obtain the information, and offered to join in petitioners’ application for the release of the information from the court in the United Kingdom. There were almost five months between the Cedillo and Snyder hearings, eight months between the Snyder hearing and the close of the evidentiary record, and six months between the close of the evidentiary record and the special master’s issuance of a decision. Thus, petitioners had approximately nineteen months within which to obtain whatever information they believed necessary to respond to Dr. Bustin’s expert reports and testimony. Given this extraordinary amount of time to secure any additional information, petitioners’ claim of prejudice fails. The special master’s conclusion to this effect was not arbitrary, capricious, or an abuse of discretion. (pp. 22, 24-25)

Immediately problematic is that petitioners do not explain how the special master’s alleged failure to consider certain evidence would have altered her decision. They allege that the special master disregarded evidence, but fail to explain the evidence’s materiality to their case. This failure, in itself, nullifies petitioners’ criticism. Yet, even presuming that petitioners’ contention is that this evidence would have tipped the scales in their favor such that they would have been able to demonstrate causation by a preponderance of evidence, their contention is flawed in two respects. First, the special master’s decision reflects that she carefully considered the entire voluminous record in this case. Second, petitioners fail to demonstrate that the special master improperly weighed the evidence in the record. (pp. 25-26)

It is of no import that the special master may not have attributed [certain] assertions to Dr. Griffin or indicated that Dr. Griffin concurred with them – it is clear that she did, in fact, consider the statements, or the underlying ideas represented by the statements… [I]t is of no import that the special master may not have attributed [certain] assertions to Dr. [Brian] Ward or indicated that Dr. Ward concurred with them – it is clear that she did not ignore the statements, or the underlying ideas represented by the statements… Had [Dr. Robert Fujinami’s] article been as valuable to petitioners’ case as they claim, surely they would have sought to subpoena Dr. Fujinami’s testimony or retain his services… It does not matter that the special master may not have attributed the assertions to Dr. [Bertus] Rima or indicated that Dr. Rima concurred with them – it is clear that she considered the statements, or the underlying ideas represented by the statements. Altogether, there is no indication that the special master ignored the evidence cited by petitioners regarding the reliability of the test results from Unigenetics when rendering her decision.(pp. 29, 31, 32, 37, 38)

Petitioners did not advance a theory of “mercury induced immune dysfunction” in [this] case. Therefore, the special master had no obligation to make such a finding. Similarly, because the special master was not obligated to consider an argument that was not advanced by petitioners, she could not have ignored evidence related to that argument…

[F]ar from disregarding the statements and various subject matter cited by petitioners, the special master both considered them and assigned them the weight that she felt appropriate. Although they never expressly discuss the materiality of these statements, it is apparent that petitioners’ grievance is that the special master did not find petitioners’ expert testimony persuasive. However, the weight afforded such evidence is within the sound discretion of the special master. Because the special master did not abuse her discretion, the court will not disturb those findings. (pp. 40-41)

Although the special master had complete control over the discovery process in this case, such control does not extend to compelling a court in a foreign jurisdiction to unseal documents. Petitioners acknowledged this fact at oral argument before the undersigned. Accordingly, the special master did not improperly shift the burden to petitioners to obtain the documents from the U.K. MMR litigation – there was no burden to shift because the special master could not have obtained the evidence sought by petitioners in the first instance. (p. 46)

Petitioners filed their motion [for reconsideration] on Friday, March 13, 2009, at 6:02 p.m. Almost all of the “new” evidence submitted with the motion was published before [the special master] rendered her decision. The deadline for filing such a motion, pursuant to Vaccine Rule 10(c), was March 5, 2009. And, pursuant to Vaccine Rule 23, the thirty-day filing deadline for any motion for review fell on Monday, March 16, 2009… The court finds no abuse of discretion here. The special master held that petitioners failed to comply with the requirements of the Vaccine Rules, and even had they so complied, the evidence was insufficient to result in the granting of their motion. Both of these reasons for the special master’s denial of petitioners’ motion were well within her discretion to make. (pp. 46-47)

Petitioners first make the blanket accusation that the special master “improperly applied Daubert to the experts’ conclusions,” rather than to the methods employed by the experts. They do not expand on this allegation to show how error was committed or provide any citation to the portions of the decision containing the alleged misapplication. Thus, petitioners place the burden on the court to divine precisely how the special master’s application of Daubert might have been improper. (pp. 50-51)

The court finds no error in the special master’s application of the framework suggested by Daubert. Federal Circuit precedent explicitly permits a special master to evaluate scientific evidence using the Daubert factors. Here, the special master considered all of the relevant evidence submitted by both parties, using the Daubert factors only to determine the reliability of that evidence and, hence, the weight it should be assigned. Indeed, by allowing all relevant evidence to be admitted into the record, regardless of its reliability, the special master was actually being quite generous to petitioners. As the special master noted throughout her decision, petitioners’ expert witnesses compared unfavorably to respondent’s expert witnesses in many respects: their credentials, their demeanor, how forthcoming they were at hearing, and the quality of their testimony. Accordingly, to the extent that petitioners are complaining that the special master’s use of the Daubert factors resulted in a failure to consider their evidence, they are mistaken. Rather, the special master evaluated all of the evidence presented by both parties and determined that the science behind petitioners’ theory was lacking. Contrary to petitioners’ contention that the investigation into the link between the MMR vaccine, along with all thimerosal-containing vaccines, and autism spectrum disorders “is ‘bereft’ of science,” the record demonstrates that there is an abundance of science in this area – just not science that supports
petitioners’ position. The special master’s application of Daubert was in accordance with the law. (pp. 53-54)

When determining fundamental fairness to the parties, there is no direct correlation between the sheer volume of evidence offered and amount of evidence that must be admitted and ultimately credited at hearing. Merely because a party offers a huge volume of evidence does not mean that the special master is duty bound to accept any of that material as persuasive. (p. 50, fn. 63)

The court finds no error in the special master’s findings. The special master’s conclusion that petitioners did not present a biologically plausible medical theory is clearly supported by the record. She found that the various aspects of petitioners’ theory were not scientifically sound and that the lynchpin of their theory was wholly unreliable. Next, the special master’s conclusion that petitioners had not established a logical sequence of cause and effect is also supported by the record. As noted above, petitioners’ theory of causation depended upon, among other things, [the child’s] immune system being damaged by the MMR vaccine (but not thimerosal-containing vaccines), the persistence of the measles virus in [the child’s] body, [the child’s] development of inflammatory bowel disease, and the presence of the measles virus in [the child’s] brain. The special master found that petitioners had demonstrated none of these necessary elements by a preponderance of the evidence. Further, the special master’s conclusion that the onset of [his] symptoms did not occur within a biologically acceptable time period following the MMR vaccination is supported by the record. She found that based on the medical records, the onset of [the child’s] symptoms did not occur at the time suggested by petitioners. Given that petitioners had not established any of the prongs of the test set forth in Althen, the special master correctly concluded that the burden of proving an alternative cause never shifted to respondent.

Petitioners’ complaints with the special master’s decision amount to nothing more than dissatisfaction with the weight she assigned to the evidence… The special master exercised her discretion appropriately here and her decision was not contrary to law. (p. 56)

The court has addressed all of petitioners’ numbered objections, finding them to be without merit. However, petitioners lodge other complaints about the special master’s conduct that despite their lack of merit, cannot be ignored. Specifically, petitioners advance the remarkable complaint that “the special master abandoned her obligation to impartially weigh the evidence. . . . [I]nstead, the special master inappropriately assumed the respondent’s role as protector of the integrity of vaccines.” Petitioners later elaborate:

During the past decade, the publicity afforded the issue of whether vaccines can cause autism has been intense. . . . [D]ue to this publicity, . . . the special master feared that a finding in [petitioners’] favor would drive down immunization rates. For this reason, to protect the integrity of vaccines, [the child’s] case, a so-called “test” case, was treated far differently than other vaccine program petitioners. First, after thousands of other autistic children had filed claims, and after years of intense public controversy over the vaccine/autism connection, the respondent was permitted to present the opinions of seventeen experts to defeat [the petitioner’s] claim. In so doing, the special master treated [the petitioners] far differently than other petitioners. In addition, disregarding the Federal Circuit’s recent decisions in Althen and Capizzano, the special master instead invoked Daubert and found virtually all of [petitioners’] evidence unreliable. For her to do so . . . was fundamentally unfair. [Petitioners were] entitled to equal treatment.

To reinforce their attack on the special master, petitioners reiterate their allegations of bias, charging:

[T]he special master ignored [petitioners’] considerable, albeit circumstantial, evidence that a persisting vaccine-strain measles virus caused [his inflammatory bowel disease] and autism… [S]he did so because of the intense national publicity this case has received… [S]he did so to assure the American public that vaccines are safe. She did so because she views her role as a protector of the integrity of our nation’s vaccines. This, however, is the role of the respondent, not a special master.

…[T]he special master, to protect vaccine integrity in a very public case, chose to impose upon [petitioners] an unattainable standard of proof. To protect the vaccine’s integrity she rejected all of petitioner’s credible evidence and simply accepted the conclusions of the respondent’s seventeen experts, denying [petitioners] the fundamental fairness required by the Vaccine Rules, ignored Congress’[s] intent in establishing the Vaccine Program, and rejected the Federal Circuit’s interpretation of that intent.

Finally, at oral argument, petitioners attempted to justify their charge of bias by arguing that it was fundamentally unfair for the special master to admit the purportedly unreliable evidence from Dr. Bustin and Dr. Rima and, thereafter, “allow[] the credibility of those witnesses to substitute for the reliability of those witnesses on key issues…”

Petitioners’ charge – that the special master feared a public backlash against vaccines if she ruled in their favor – is preposterous. There is not a shred of evidence to support petitioners’ claim; it rests solely on petitioners’ speculation. Merely because the special master found that petitioners did not carry their burden of proof does not diminish her integrity or render her decision unsupported. Claims of error by a losing party against a decision maker are hardly unusual, but should be grounded in reality. There is an enormous chasm between disagreement with a judicial officer’s findings of fact and conclusions of law and the accusation that the judicial officer is, in essence, intellectually dishonest. An allegation of bias raises ethical concerns, not errors in judgment (i.e., legal or factual errors). Although petitioners appeared to understand this distinction at oral argument, they maintained that the special master was biased against them by unfairly “shift[ing] the burden of discovery” and “weighing… the evidence…” However, alleged errors of this nature are grounded on purportedly mistaken evidentiary rulings, factual findings, and legal conclusions, not bias. And, the court has already held that it identified no legal or factual error in the special master’s decision.

Indeed, it is abundantly clear from her decision that the special master took great care in considering all of the evidence in the record–whether presented by petitioners or respondent – and applying the appropriate legal standards in evaluating that evidence. As the Court of Federal Claims stated in Ultimo:

This sort of personal attack on the [special master] is highly inappropriate, contentious, and unpersuasive. . . . Petitioner . . . accuses the [special master] of subverting the intent of Congress in establishing the Program. The court will not condone such frivolous, unsubstantiated accusations. Accordingly, the court finds that petitioner’s… objection is completely without merit. Petitioner is forewarned that any repetition of such groundless accusations may cause the court to entertain sanctions against petitioner and petitioner’s counsel pursuant to RCFC 11. 28 Fed. Cl. at 153. (pp. 56-59)

As the special master’s decision makes clear, [the child], and by extension, his family, have dealt with significant adversity for many years, and, like the special master, the court is very sympathetic to their circumstances. However, the court cannot be ruled by emotion and base its determination solely upon the adversity endured by petitioners’ family. Moreover, it is not the task of this court to determine whether vaccines cause autism or other neurodevelopmental disorders. Rather, the court must decide whether the special master, considering the record as a whole, rendered a decision that was arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law. She did not. Her decision was entirely rational and fully supported by the record. Thus, the court DENIES petitioners’ motion for review. (p. 59)

Another Autism "Test Case" Appeal Dismissed · 182 days ago

On August 6, 2009, Judge Thomas C. Wheeler of the United States Court of Federal Claims affirmed the Vaccine Injury Compensation Program’s February 12, 2009 dismissal of Cedillo v. U.S. Department of Health and Human Services (Case No. 98-916V), one of the three Omnibus Autism Proceeding test cases which sought to establish that vaccines can provoke the development of autism.

In his original ruling, Special Master George Hastings found that the petitioners had failed to demonstrate that either the MMR vaccine or thimerosal-containing vaccines can harm infant immune systems, cause gastrointestinal dysfunction, or cause autism; that they had failed to demonstate that a vaccine reaction had harmed their child’s immune system, caused her gastrointestinal problems, or caused her to become autistic; and that they had failed to demonstrate that an MMR vaccination caused her mental retardation or seizure disorder. Additionally, the Special Master deemed ureliable the testing the petitioners offered to show the presence of the measles virus in their own child and in other autistic children.

The ruling on appeal adds to the accumulation of comprehensive, reasoned judicial assessments of the scientific evidence offered in support of vaccine causation hypotheses and of the credibility of the “scientific experts” who promote those hypotheses in the courtroom and the clinic.

From the decision:

The Cedillos assert seven arguments in their motion for review to show that the Special Master’s decision is arbitrary, capricious, an abuse of discretion, and contrary to law:

(1) A panel of three Special Masters should not have heard the general causation evidence;

(2) The Special Masters should not have allowed the last-minute expert reports and testimony of Dr. Stephen Bustin;

(3) The Special Master improperly discounted the medical diagnoses and opinions of [the child’s] treating physicians;

(4) The Special Master improperly ignored concessions made by Respondent’s expert witnesses;

(5) The Special Master ignored important aspects of [the petitioners’] evidence;

(6) The Special Master abused his discretion by refusing to consider important post-hearing evidence; and

(7) The Special Master’s decision was contrary to law. (p. 9)

A hotly contested issue in this case is whether the measles virus detection tests performed by the Unigenetics Laboratory in Dublin, Ireland produced reliable results. Petitioners’ expert witnesses, Dr. Marcel Kinsbourne and Dr. Arthur Krigsman, acknowledged that their opinion on causation depended upon the existence of a reliable laboratory finding of persistent vaccine-strain measles in the body of the person tested. Thus, absent evidence of persistent vaccine-strain measles in [the child’s] body, Dr. Kinsbourne and Dr. Krigsman cannot show that the MMR vaccine caused [her] autism or her inflammatory bowel disease…

Weighing all of the evidence, the Special Master concluded that the Unigenetics testing for the detection of measles virus was not reliable. The Special Master emphasized that other researchers had been unable to replicate the Unigenetics findings. He found it significant that Unigenetics had failed to employ “sequencing” in its testing procedures. He was troubled by the many problems with Unigenetics’ procedures, facilities, and equipment. Among these were the failure to employ “blinding” procedures so that the laboratory technicians would not know whether the samples being tested were from the patient group of interest. These procedures are regarded as “critical” to prevent conscious or subconscious bias from affecting test results. The Special Master found the efforts of [petitioners’ experts] Dr. Hepner and Dr. Kennedy to defend the Unigenetics work largely ineffective. Their testimony was “too summary and nonspecific to answer the criticisms leveled by [respondent’s experts] Drs. Bustin and Rima, which were specific and detailed.” Moreover, even the Unigenetics’ test results failed to identify any vaccine-strain measles, which would have been critical to linking the MMR vaccine to autism or inflammatory bowel disease. Petitioners needed to show that the measles virus allegedly detected in [the child’s] tissue sample derived from the MMR vaccine, rather than the natural, “wild” form of measles virus, but they did not. On balance, the Special Master concluded that Respondent’s experts, Drs. Ward, Bustin, Rima, and MacDonald, had “vastly more experience and academic credentials” than Petitioners’ expert, Dr. Hepner, and that Dr. Bustin’s PCR experience and Dr. Rima’s measles virus experience far exceeded Dr. Kennedy’s.

The Court performed a detailed review of the record and the Special Master’s analysis of the Unigenetics testing. The Court agrees with the Special Master that the evidence strongly favors Respondent’s position. Aside from the superior qualifications and experience of Respondent’s experts, the Court finds the results of the 2006 Afzal and D’Souza studies to be most compelling. The researchers in those studies sought to replicate the Uhlmann Study upon which Petitioners so heavily rely. Not only did the Afzal and D’Souza researchers fail to replicate the results of the Uhlmann Study, they came to a conclusion directly opposite to the Uhlmann Study, and they offered likely reasons to explain how the Uhlmann Study had gone astray. The Court also finds that the flaws in the Unigenetics Laboratory procedures were so pervasive that the test results simply cannot be trusted… The Special Master’s decision regarding the Uhlmann Study and the Unigenetics testing is reasonable in all respects, and could not in any sense be regarded as arbitrary, capricious, or an abuse of discretion. (pp. 13-14)

While it may be true that requiring Petitioners to persuade three special masters of their “general causation” theory would have violated the fundamental fairness provision of Vaccine Rule 8, Petitioners cite nothing in the Special Master’s decision or the record to indicate that they were held to an impermissible burden. To the contrary, while Special Masters Vowell and Campbell-Smith sat on the bench with him during the evidentiary hearing, Special Master Hastings explained that the role of the two additional Special Masters was not to decide Cedillo, but to hear the general causation evidence provided by expert witnesses so that they could apply the evidence to the other individual test cases assigned to them. Special Master Hastings noted, “[w]hile the ‘general causation’ evidence is common to the three cases, each of us has analyzed that common evidence independently of the other two; each has reached his or her own conclusion.”

A review of the record and the Special Master’s decision shows that Petitioners were not required to persuade Special Masters Vowell and Campbell-Smith of the merits of their case. The assignment of two additional Special Masters to hear the “general causation” evidence in the test cases, and to assist in deciding some 5,000 autism cases, is an eminently reasonable case management approach. When asked at the oral argument to identify any prejudice from having a three-member panel, Petitioners’ counsel responded, “I don’t know that there was any, Your Honor.” Petitioners have failed to establish that the presence of three special masters required them to convince anyone beyond Special Master Hastings to prevail in their case, and, therefore, their challenge to the procedures used at the hearing is unavailing.

At the July 7, 2009 oral argument, the Court asked Petitioners’ counsel how the Special Master’s handling of Dr. Bustin’s reports from the British proceedings prejudiced the Cedillos, if at all. Petitioners’ counsel could not identify any prejudice aside from short-term disruption, explaining that he thought Dr. Bustin was helpful to the Cedillos’ case, and admitting, “there was no ultimate prejudice” from Dr. Bustin… [T]he Court concludes that the Special Master’s admission of Dr. Bustin’s testimony and expert reports was reasonable, Petitioners suffered no prejudice therefrom, and the Special Master did not abuse his discretion in this regard. The Special Master further observed, and the Court agrees, that he would have decided the petition on the merits the same way even if he had disregarded Dr. Bustin’s testimony and expert reports. (pp. 17-20)

Upon careful review of the “concessions” cited by Petitioners, the Court finds that Respondent’s expert witnesses indeed agreed with some aspects of Petitioners’ theory of causation. However, in their motion for review, Petitioners simply have woven together as many areas of agreement as possible, and have blindly overlooked the compelling conclusions advanced by Respondent’s experts.

This is not a case where the Special Master declined to consider important evidence, or failed to admit relevant exhibits or testimony. To the contrary, the Special Master thoroughly considered every viewpoint of every expert witness, both Petitioners’ and Respondent’s, and concluded that the evidence was “overwhelmingly” in Respondent’s favor. This Court will not second guess a Special Master’s fact-intensive conclusions, especially when medical evidence of causation is in dispute. (pp. 22-23)

Petitioners incorrectly contend that the Special Master afforded the records of the treating physicians “absolutely no probative value.” The Special Master devoted a separate section of the decision to the records of the treating physicians. As the Court finds that the Special Master properly evaluated these records, it will not disturb the Special Master’s conclusions…

Petitioners challenge the Special Master’s assessment of Dr. Krigsman, their expert in gastroenterology. Petitioners allege that the Special Master “reserved special venom” for Dr. Krigsman and failed to evaluate his diagnosis of [the child], while crediting instead the testimony of Respondent’s expert, Dr. Hanauer. Contrary to Petitioners’ assertion, the Special Master analyzed Dr. Krigsman’s testimony in great detail, and found it unpersuasive. Dr. Krigsman testified that [the child] has inflammatory bowel disease, which the MMR vaccination caused. The Special Master rejected this view…

The Special Master noted that Dr. Krigsman diagnosed [the child] with inflammatory bowel disease in July 2003, before he ever met or examined her. He also observed that Petitioners never offered any rebuttal testimony to Dr. Hanauer’s criticisms of Dr. Krigsman’s opinion. The Special Master offered three chief reasons why Dr. Krigsman’s opinion should be rejected. First, Dr. Krigsman relied upon the discredited Unigenetics testing in forming his opinion. Second, the Special Master determined that Dr. Krigsman had a “grossly mistaken understanding of the history of [her] gastrointestinal symptoms,” and that his testimony was inconsistent with [her] medical records. Third, he found Dr. Krigsman’s conclusion that [the child] suffered from chronic gastrointestinal inflammation to be “substantially outweighed by a combination of the medical records and the testimony of respondent’s experts, especially Dr. Hanauer.” The Court will not second-guess the Special Master’s analysis and credibility assessments of Dr. Hanauer or Dr. Krigsman.(pp. 21, 24-25)

The Special Master acknowledged the testimony of Petitioners’ expert, Dr. Marcel Kinsbourne, that persistent measles virus in the human brain might cause a different disorder besides SSPE or MIBE. The Special Master explained, however, that Dr. Kinsbourne “supplied no evidence for such a possibility, beyond his own unsubstantiated speculation.” …The evidence on neuroinflammation supports the Special Master’s conclusion that Respondent’s experts presented a far more compelling position, and were much better qualified, than Petitioners’ experts. The Special Master carefully examined every position advanced by the parties in his undeniably thorough decision. The Court rejects Petitioners’ assertion that the Special Master’s determination was arbitrary, capricious, or an abuse of discretion.

The Special Master provided a full and careful analysis of [the petitioners’] experts’ testimony and their qualifications, and concluded Petitioners failed to demonstrate that thimerosal damaged [the child’s] immune system. The Court sees no basis for disturbing the Special Master’s evaluation of these expert witnesses… Based upon all of the expert testimony, the Special Master found no evidence that the amount of ethyl mercury in thimerosal causes any immune dysfunction. The record supports this determination. Furthermore, the Special Master provided sufficient reasoning in his decision for his acceptance of Dr. Brent’s expert analysis instead of Dr. Aposhian’s. Upon careful review, the Court will not disturb these conclusions. (pp. 26-27)

Petitioners challenge the dismissal of their motion for reconsideration, contending that the Special Master abused his discretion by refusing to consider significant post-hearing evidence. Petitioners filed their motion for reconsideration with the Special Master on March 13, 2009, just three days before a motion for review would have been due in this Court… Petitioners offered no explanation for filing their motion outside of the 21-day time period. As the Special Master speculated, by filing on March 13, 2009, Petitioners seemingly positioned the motion for a prompt ruling from the Special Master without an opportunity for Respondent to answer… The Court finds that the Special Master acted well within his discretion in denying Petitioners’ motion for reconsideration. Petitioners did not timely file their motion under Vaccine Rule 10(e), and the Special Master properly determined that there was no reason “in the interest of justice” to consider the evidence proffered with the motion. (pp. 28-29)

Petitioners first argue that the Special Master improperly applied Daubert in evaluating the reliability of their expert testimony and other scientific evidence. In Daubert, the Supreme Court set forth four factors for determining the admissibility of scientific evidence at trial. These factors are (1) general acceptance in the scientific community, (2) whether the theory has been subjected to peer review and publication, (3) whether it can and has been tested, and (4) whether the known potential rate of error is acceptable. According to Petitioners, courts may only use the Daubert factors to assess expert witnesses’ methodology and not their ultimate conclusions. Therefore, the Special Master acted contrary to the law in applying Daubert to assess the reliability of Petitioners’ expert witnesses and other scientific evidence. Federal Circuit precedent clearly permits the Special Master to apply Daubert when evaluating the reliability of the parties’ evidence. In Terran v. Secretary of Health and Human Services, the Court of Federal Claims concluded that “Daubert is useful in providing a framework for evaluating the reliability of scientific evidence,” both under the Federal Rules of Evidence and in Vaccine Act cases. In affirming this decision, the Federal Circuit found reasonable the trial court’s application of Daubert to assess the reliability of an expert witness. Furthermore, the Supreme Court has clarified language in Daubert stating that the focus of a Daubert inquiry must be “‘solely on principles and methodology, not on the conclusions that they generate’” by acknowledging that “conclusions and methodology are not entirely distinct from one another… A court may conclude that there is simply too great an analytical gap between the data and the opinion proffered.”

Here, the Special Master concluded that “another important aspect of the causation-in-fact law under the [Vaccine] Program concerns the factors that a special master should consider in evaluating the reliability of expert testimony and other scientific evidence relating to causation issues.” He then referenced the Daubert factors “that federal trial courts should utilize in evaluating proposed expert testimony concerning scientific issues.” In applying Daubert, the Special Master simply found that the evidence did not support the conclusions proffered by Petitioners’ experts. The Special Master had the discretion under Terran to apply Daubert when assessing the conclusions of the parties’ expert witnesses, and, therefore, he did not act contrary to law. (pp. 29-30)

The Special Master determined that Petitioners failed to offer a reliable medical theory as to how the MMR vaccine can cause autism or inflammatory bowel disease, and that any such theories were highly speculative… The Special Master’s conclusion that Petitioners failed to demonstrate any relationship between the MMR vaccine and [the child’s] autism is eminently reasonable. He determined that they offered “virtually no evidence” to support their claim… The Special Master provided substantial evidentiary support for his conclusion that Petitioners failed to show, by a preponderance of the evidence, a scientific temporal relationship between the MMR vaccine and [the child’s] autism or gastrointestinal problems. There is no evidence to support Petitioners’ claim that the Special Master elevated the burden of proof set forth in Althen.

Petitioners allege that the Special Master disregarded precedent in which the Court granted relief to petitioners, particularly where the MMR vaccine caused injury, based on evidence allegedly similar to or less compelling than the evidence presented here. Petitioners point to a list of cases in which medical records, affidavits, expert testimony, and scientific articles, all based on circumstantial evidence alone, established that vaccines have caused certain injuries… The Special Master explicitly rejected Petitioners’ argument for faulty logic, noting that Petitioners failed to mention the thousands of other cases in which special masters have denied relief for failure to prove by a preponderance of the evidence that a vaccine caused an injury. Furthermore, he concluded that [the child’s] case bears no resemblance to those cited by Petitioners… The Court finds no legal error in the Special Master’s determination that these cases are factually distinct from the case at hand. Unlike the medical issues raised in other Vaccine Act cases, autism is not an area “‘bereft of complete proof.’” As the Special Master explained in his decision, scientists have performed numerous, reputable epidemiological studies worldwide that have attempted, and failed, to detect an association between childhood vaccinations and autism. Furthermore, Petitioners have again mischaracterized the law under Althen. While a special master must resolve “close calls” in favor of a petitioner, Special Master Hastings concluded that this “is not a close case;” rather, “[t]he overall weight of the evidence is overwhelmingly contrary to the petitioners’ causation theories.” Petitioners still have the burden of proving their claims by a preponderance of the evidence, and the Special Master reasonably concluded that they failed to do so. Accordingly, Petitioners’ argument that the Special Master’s decision was not in accordance with the law is without merit. (pp. 32-33)

The issue before our Court is not to determine the causes of autism. The Court can only hope that medical professionals succeed in identifying the causes and developing a cure for this tragic disease. Rather, the Court’s task is to weigh the Special Master’s February 12, 2009 decision under the applicable review standards of the Vaccine Act, and determine whether it should affirm or modify the decision to any extent. After performing this review, the Court is satisfied that the Special Master’s decision is rational and reasonable in all respects, and is in accordance with law. For the reasons addressed above, the Special Master’s decision is AFFIRMED. (p. 33)

As with the Hazlehurst “test case” dismissal issued on July 24, any appeal of this latest ruling in Cedillo v. HHS must be filed in the U.S. Court of Appeals for the Federal Circuit.

Interagency Autism Coordinating Committee Seeks Feedback · 192 days ago

The Interagency Autism Coordinating Committee, responsible for developing the U.S. national strategic plan for autism research, is again seeking suggestions from the general public regarding autism research needs and priorities.
The Committee’s official Request For Information (NOT-MH-09-013) is reproduced in its entirety below. For full consideration and official publication, responses must be received by by August 21, 2009, via the web interface at http://www.acclaroresearch.com/oarc/rfi.

Request for Information (RFI) Updating the Interagency Autism Coordinating Committee Strategic Plan for Autism Spectrum Disorder (ASD) Research

Notice Number: NOT-MH-09-013

Key Dates

Release Date:  July 23, 2009
Response Date:  August 21, 2009

Issued by

National Institute of Mental Health (NIMH)

Description

On behalf of the Interagency Autism Coordinating Committee, the NIMH is seeking comments to inform the annual update of the IACC Strategic Plan for Autism Spectrum Disorder (ASD) Researc as required by the Combating Autism Act of 2006 (P.L. 109-416).

Background

The IACC was established as a result of The Combating Autism Act. The act requires that the IACC develop a strategic plan for autism research and update the strategic plan annually. The IACC is composed of both Federal and public members.  The first IACC Strategic Plan for ASD Research was developed through an extensive process engaging a wide range of Federal agencies and public stakeholders. The Strategic Plan is organized around six questions that are important for people with ASD and their families:

  1. When should I be concerned?
  2. How can I understand what is happening?
  3. What caused this to happen and can this be prevented?
  4. Which treatments and interventions will help?
  5. Where can I turn for services?
  6. What does the future hold?

The purpose of this RFI is to solicit input from ASD stakeholders to inform the next update of the Strategic Plan.

Information Requested

For each section of the IACC Strategic Plan, please provide input on new areas of research or areas in which additional research is needed. Please include suggestions regarding missing or underrepresented knowledge areas, new opportunities needed for advancing research and knowledge about ASD, and suggestions for prioritizing research objectives.

The information that you provide will become part of the public record.  You have the option of posting your responses anonymously or you may choose to have your name associated with your response.

How to Submit a Response

All comments must be submitted electronically via this web-based form (http://www.acclaroresearch.com/oarc/rfi/). Responses to this RFI are optional and will be accepted through August 21, 2009. You will receive an electronic confirmation acknowledging receipt of your response, but will not receive individualized feedback on any suggestions. Please do not include any personally identifiable or confidential information that you do not wish to make public. No basis for claims against the U.S. Government shall arise as a result of a response to this request for information or from the Government’s use of such information.

All responses will be made publicly available on the IACC website following the closing deadline for this notice.

Inquiries

Specific questions about this RFI should be directed to:

Attention: RFI on Updating the Strategic Plan for ASD Research
Office of Autism Research Coordination
Office of the Director
National Institute of Mental Health
6001 Executive Boulevard, Room 8235, MSC 9669
Bethesda, MD 20892-9669
Email: iacc@mail.nih.gov

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