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July 26, 2002 CALENDAR LISTING: EVENTS@doitnow.com

ADVOCACY

* FAX Alert: Parents Rights to Sue Over Vaccine Damage Under Assault

* Frist Urges Action To Alleviate Nation's Vaccine Shortage

* Vaccine Injury Alliance - Analysis S 2053 By the Numbers...

* COMMENTARY: We Are In The Midst Of An International Epidemic

RESEARCH

* In Search Of a Place On Genetic Science Map

EDUCATION

* Researchers: Early Intervention For All Kids With Reading Difficulties

ADVOCACY

FAX Alert: Parents Rights to Sue Over Vaccine Damage Under Assault "This is a tragic injustice."

[This is from the National Vaccine Information Center. Our reporting of this and other similar action alerts does not necessarily indicate Schafer Autism Report's endorsement. These are presented for our readers information only.]

Two days ago NVIC put out a notice about SB 2053 or the Frist bill. This bill would amend the Vaccine Injury Compensation Program in a way that would benefit drug companies and shield them from liability. There are many provisions to this bill but the most problematic one will stop the ability of a vaccine injury victim to bring a lawsuit in civil court.

Several people called and e-mailed and felt frustrated that they had not gotten the information in time.

There Is Still Time!

On Wednesday this committee did not get to this bill so it is scheduled for next Wednesday, July 31, 2002. It will go for mark-up and be voted on in that committee.

Whether you have a vaccine injured child or not, you need to stand up for the right of maintaining your rights to sue in the court system. This could be the beginning of the end for all sorts of product liability related lawsuits.

NVIC worked hard to preserve the right to sue when this original law was passed. The drug companies are worried because of the lawsuits involving Thimerosal and autism. It makes you wonder what documents might be discovered in a civil case that would never be uncovered in the compensation program. Senator Frist and the drug companies are trying to blame the current vaccine shortages on pending Thimerosal lawsuits that haven't even gotten to court yet. Drug companies have lived liability free since 1987 and now they are using this as an excuse to take away the rights of vaccine-injured Americans. Senator Frist tells us in his press release

(below) that this bill will bring balance back to the Vaccine Injury Compensation Program.

Not true!

The Burton-Waxman bill, HR 3741 is a much better bill that addresses the existing problems in the compensation program, not problems outside the program such as pending lawsuits.

There are a handful of Senators who will handle this bill next week. If you live in a state that is listed please get in touch with their office immediately. If you don't see your state listed contact your Senator and tell him to oppose this bill and to call Senator Frist and other committee members and ask them to oppose it.

Edward Kennedy (D-MA) senator@kennedy.senate.gov

Tom Harkin (D-IA) tom_harkin@harkin.senate.gov

Jeff Bingaman (D-NM) Senator_Bingaman@bingaman.senate.gov

Patty Murray (D-WA) senator_murray@murray.senate.gov

Mike Enzi (R-WY) Senator@enzi.senate.gov

Christopher Bond (R-MO) kit_bond@bond.senate.gov

Susan Collins (R-ME) Senator@Collins.senate.gov

Jeff Sessions (R-AL) senator@sessions.senate.gov

To call them: 202-224-3121

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[Related news item.]

Frist Urges Action To Alleviate Nation's Vaccine Shortage

Cites HHS Secretary's Advisory Commission's Recent Support for Senate Legislation

WASHINGTON, D.C. - To rally action on proposed legislation to reduce the critical national vaccine shortage, U.S. Senator Bill Frist (R-TN) today, June 24, spoke on the Senate floor to urge congressional action to approve legislation he introduced in March. On June 6, his proposal gained additional momentum when the Advisory Commission for Childhood Vaccines - which advises the Secretary of Health and Human Services on improving the Vaccine Injury Compensation Program - voted in favor of most of the Frist bill's provisions.

The following excerpts are from Senator Frist's statement on the Senate floor:

"Today, many parents are being turned away with their children still vulnerable to a range of dangerous and often deadly diseases. Five vaccines that prevent eight childhood diseases have been in short supply in the United States since last summer.

"...the longer this shortage continues, the more vulnerable our children will become. If we do not take prudent steps today to address current and recurring vaccine shortages, it is almost certain American children will experience an outbreak of diseases that could be prevented." "Today, only four manufacturers produce vaccine for America's children - just two of which are American companies. And new companies that may want to produce vaccines are confronted with the high risk of liability and little profit motive."

"...one pending lawsuit seeks $30 billion in damages while the total value of the global vaccine market is only $5 billion. This legal uncertainty has contributed to an exodus of manufacturers from the vaccine market and a subsequent increase in vaccine prices. In some cases, only one manufacturer is producing some of our most critical vaccines."

"The Improved Vaccine Affordability and Availability Act, S. 2053 would restore balance to the Vaccine Injury Compensation Program. It would help compensate those who suffer serious side effects from vaccines while ensuring that unwarranted litigation does not further destabilize our vaccine supply."

"The decision before us is whether to build on the success of vaccines in the 21st Century. And I speak not only of vaccines that already exist and may be in short supply, but future vaccines that will prevent HIV/AIDS or cure Alzheimer's or help the United States win the war on terror through the development of safer vaccines to protect us, and our children, against biological agents."

Senators Kay Bailey Hutchison (R-TX) and Jim Bunning (R-KY) have cosponsored Senator Frist's "Improved Vaccine Affordability and Availability Act." The bill would require the federal government to build and maintain a six-month stockpile of prioritized vaccines. It also would expand the funding available for state and local efforts to boost immunization rates among adults and children who are underserved or at a high risk to vaccine-preventable diseases.

In addition, the bill would restore balance to the Vaccine Injury Compensation Program. This program was created in the mid 1980's to quickly compensate those who suffer serious side effects from childhood vaccines, while reducing the legal risk to doctors, nurses and manufacturers.

Frist is a member of the Health, Education, Labor and Pensions Committee and a heart and lung transplant surgeon.

* *

[Related Item. Thanks to Jeff Sell.]

Senator Bill Frist (R-TN) has introduced the "Improved Vaccine Affordability and Availability Act" or S 2053, to amend the National Vaccine Injury Compensation Program ("Program"). While undoing every gain that petitioners' families have made over the past several years, S 2053 also represents an attack on the very spirit of the Vaccine Program as it sacrifices the best interests of our children for the sake of protecting the vaccine manufacturers. Unlike its counterpart bill in the House of Representatives, HR 3741, the Frist amendment in the Senate does little if anything to protect or defend, let alone extend the rights of children in this country who have been injured by their recommended childhood vaccinations. Rather, it is determined, almost cynical, in its apparent disregard of those rights. While nearly every section of the amendment is disheartening, several sections stand out.

Reducing Public Awareness

SEC. 201: Administrative Revision of the Vaccine Injury Table

S 2053 cuts in half the time allowed for public comment (from 180 days to 90 days) when a change in the Vaccine Injury Table is proposed. It further eliminates the Secretary of HHS' obligation to hold a public hearing on the issue. The effect is to drastically reduce the already scant public participation in this Program.

Removing All "OPT-OUT" Actions

SEC. 202: Equitable Relief

S 2053 begins, here in Sec. 202, the first of its several-pronged attack, and ultimately, elimination of, the various forms of civil actions currently ongoing throughout the country, including the class actions seeking medical monitoring. By including the language "equitable relief' in the damages or awards sought section, S 2053 clearly removes the possibility of civil suits seeking medical monitoring, or other, non-monetary awards. Medical monitoring suits are specifically eliminated in SEC. 214. The effect of this provision, along with Sections 203-204 and 214-217 is to make sure that anyone with an injury from a vaccine MUST go through the Program first, and all class actions of any kind are eliminated.

SEC. 203: Parent Petitions for Compensation

S 2053 eliminates parental claims for loss of consortium, society, companionship or services, loss of earnings, medical or other expenses, and emotional distress until after a claim has been made through the Program. The effect of this provision is to, again, make sure everyone has to go through the Program first, and eliminates another form of the civil suits ongoing across the country. The irony here is that the bill does not create damages for parents under the program, which are comparable to civil damages, and it does not make it clear that parental claims in the civil system will have their statutes of limitations tolled by filing a child's claim in the program. The practical effect of this may be to eliminate parental claims altogether.

SEC. 214: Clarification of Standards of Responsibility

S 2053 requires, in this section, a "present physical injury", preventing any actions for medical monitoring. The section further specifically adds the "equitable relief' language and eliminates actions for claims of "medical monitoring, or increased risk of harm". This provision may have the added effect of denying compensation to someone who had a terrible injury under the program which lasted for some period of time (even years), but who has now recovered and does not have a "present physical injury." This is a good example of how drafting language with one purpose may have other dramatic, unintended consequences.

SEC'S. 215-217: Clarification of Definitions of Manufacturer, Vaccine-Related Injury or Death and Vaccine

S 2053, in these three sections, affirmatively states that an "adulterant or contaminant shall not include any component or ingredient listed in a vaccine's product license application or product label." The purpose of these clarifications is to eliminate the legal theory that Thimerosal is a contaminant or adulterant.

SEC. 204: Jurisdiction to Dismiss Actions Improperly Brought

S 2053 gives the manufacturers the right to remove to the US Court of Federal Claims any civil action against the manufacturer, brought by a family without first going through the Program, and requires the USCFC to dismiss the action. SEC. 204 works in tandem with 202-203 and 214-217 in preventing direct actions against the manufacturers.

With parental claims, medical monitoring and Thimerosal as adulterant representing the only options for families outside of the Program, the Frist amendment acts as a three strikes and you're "in" bill, effectively preventing any direct action against a vaccine manufacturer without first going through the Program.

Strengthening Goliath's Position

SEC. 206: Clarification of When Injury is Caused By Factors Unrelated to Administration of Vaccine

S 2053 gives the Government additional weapons in its arsenal to knock down petitioners' arguments and ultimately deny claims. It does so by creating "new~~ causes for the injury that Frist's amendment deems "unrelated" to the vaccine. This provision allows the Respondent to use medical ignorance to deny compensation. The government normally has to prove alternate causes of injuries. Senator Frist wants to give them presumptive alternate causes. The result will be to deny compensation to even more claimants. Proving causation with one's hands tied behind the back is hard enough, but Frist wants to tilt the playing field even further, and the children be damned.

Weakening David's Position

SEC. 208: Basis for Calculating Projected Lost Earnings

S 2053 destroys Petitioners' hard-fought and grudgingly conceded progress in getting realistic and "real world" compensation for injured children. The amendment reinforces the Program's original language and gives the Secretary of HHS the sole right to determine what is an "appropriate" formula for determining projected lost earnings. In the past this "discretion" has led to the absurd and contradictory result of injured children's projected earnings being reduced by Social Security taxes, though they will never work and pay into Social Security, AND being reduced by the FULL COST OF A HEALTH INSURANCE POLICY (sometimes thousands of dollars) despite the fact that "average" workers are NOT responsible for the full cost, but rather a sharply reduced amount as their employer pays the balance. It has further allowed the Government to selectively use data from the Bureau of Labor Statistics while refusing to provide Petitioners with data.

Other Key Points

S 2053 fails to provide a "look back" provision, as in HR 3741 that will allow hundreds of families to exercise their rights under the Program. This is a tragic injustice

S 2053 fails to extend the statute of limitations for death cases - death cases must still be filed within two years of the date of death.

S 2053 fails to provide for interim attorneys fees. The families of injured children have a right to effective counsel. The children injured by vaccines face an adversary of nearly unlimited financial and scientific resources. Their cases reach levels of complexity, both medical and legal, that would rival any toxic-tort class action. Their lawyers are, in effect, pro bono representatives throughout the course of the case, often for years, and unable to meet or even approach a level playing field with the Government's lawyers.

S 2053 creates a brutal and unforgiving legal battle, ostensibly in the "best interests" of injured children, strips them of their defenses and then forces them onto the field. In short, S 2053 not only bloodies the battlefield; it fails to render even basic aid to the wounded.

* * *

We Are In The Midst Of An International Epidemic

April 22, 2002

"POWER of ONE - IDEA" Rally, Washington DC

By Andrew Wakefield

We are in the midst of an international epidemic.

Those responsible for investigating and dealing with

this epidemic have failed.

Among the reasons for this failure is the fact that

they are faced with the prospect that they themselves may be

responsible for the epidemic. Therefore, in their efforts to

exonerate themselves they are an impediment to progress. I

believe that public health officials know there is a problem;

they are, however, willing to deny the problem and accept the

loss of an unknown number of children on the basis that the

success of public health policy - mandatory vaccination - by

necessity involves sacrifice. Neither I, nor my colleagues

subscribe to the belief that any child is expendable. History

has encountered and dealt with such beliefs.

You, the parent's and children, are the source of the

inspiration and strength for our endeavours; our quest for

truth through science - a science that is compassionate,

uncompromising and uncompromised.

I do not mean to stir you to mutiny, but be assured that

armed with this science it is in your power to force this issue,

in your pediatricians office, in Congress, in the Law Courts.

Keep faith with your instincts - they have served you well.

Andy Wakefield

* * *

RESEARCH

In Search Of a Place On Genetic Science Map

Group Wants to Establish Medical Research Center

A group of leading scientists, executives, health experts and a few self-described dreamers hatched a bold plan last week for Loudoun's future: to create one of the country's leading centers for genetic medicine and build it in the county.

Loudoun's Science and Technology Cabinet, a group of appointed advisers, backed the proposal after listening to two leading genetic researchers describe their latest breakthroughs in a room with a stunning vista of the Potomac River.

Terry Sharrer, the group's leader and chairman of the National Foundation for Cancer Research, said he envisions a clinical facility focused on cancer and on neurological and degenerative diseases. The idea is to create an environment where cutting-edge genetic research can be turned into life-saving treatments as quickly as possible -- "a place where gene medicine has room to grow," Sharrer said.

It's a grand task that would require cooperation among a number of local hospitals, medical schools and other players who don't always see things the same way. And it would be very expensive.

"This is all like nailing jelly to the wall right now," Sharrer said. "I have no idea how much these things will cost. If we did know what these things would cost, we wouldn't do them."

But many in the group, which broke down into smaller teams to consider specific challenges, said they wanted to go ahead. "Terry has been dreaming very big," said Larry Rosenstrauch, Loudoun's director of economic development.

Dietrich Stephan, a leading genetics researcher, told the group that they were embarking on a difficult but important task. He described what he termed the medieval current treatments for cancer and said, "the era of the genome" promises important new cures.

The meeting at the River Creek Country Club came two days before WorldCom Inc., one of the county's top employers, filed the biggest bankruptcy in history. The county's telecom woes help explain why local officials are eager to support such expansive thinking.

The Howard Hughes Medical Institute's plan to build a major research center in Loudoun, specializing in the nexus of biology and computers, is also driving the effort to create a center for advanced medicine.

In addition to the clinical facility, the cabinet members discussed trying to attract a genomics medical school that would expose students to the scientific, legal and ethical aspects of using genes as a basis for diagnosis and treatment. Members also envision commercial ventures being developed from the clinical center.

Among those who took part in the meeting were Donald S. Beyer Jr., Virginia's former lieutenant governor; Roland Tibbetts, a longtime official at the National Science Foundation; and Peter Hotez, a George Washington University professor who chairs the Department of Microbiology and Tropical Medicine and specializes in vaccine development. (c) 2002 The Washington Post Company

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EDUCATION

Researchers: Early Intervention For All Kids With Reading Difficulties

National experts in the field of reading and literacy have found research evidence that challenges federal policy for making children eligible to receive some special education services. Currently, a child must score substantially higher on intelligence tests than on achievement tests, without exhibiting other traits that might cause academic difficulties, to qualify for special education resources in reading. A meta-analysis published in the summer 2002 issue of the American Educational Research Journal questions the use of this criterion in addressing reading difficulties of children.

With reauthorization of the Individuals with Disabilities Education Act (IDEA) legislation pending before the U.S. Congress, researchers Karla K. Stuebing, FSD Data Services, Inc.; Jack M. Fletcher and Josett M. DeLoux, Department of Pediatrics, University of Texas Health Science Center; G. Reid Lyon, National Institute of Child Health and Human Development; and Sally E. and Bennett A. Shaywitz, Yale University School of Medicine, present research that supports early intervention for all children who experience difficulties learning to read, regardless of cause.

Their meta-analysis centers on the question of whether the needs of learning disabled children, who have been identified because of discrepancy between their intellectual potential and their levels of achievement, differ from the needs of children who do not demonstrate such a discrepancy but experience, nevertheless, difficulties in reading.

The authors reviewed 320 potential studies and, through a carefully constructed process, eventually selected 46 studies that compare IQ-discrepant and IQ-consistent groups. According to the researchers, "The overlap between poor readers identified as learning disabled and those not so identified is substantial, and little external validity exists for the differentiation of reading disability on the basis of IQ- discrepancy."

When discrepancy is used in federal regulations as a criterion for establishing learning disability, ". . .the provision of services favors children with higher IQ scores." This practice might be justified if such a distinction resulted in increased facility in reading skills or identified children with different learning haracteristics. The authors contend, however, that there is little evidence to support that assertion.

Instead, they report, "The solution is to carefully assess reading and reading-related skills in students for whom there is concern about reading." These assessments should address the instructional needs of each child. Along with early intervention, continuous monitoring of progress ". . .would facilitate the ultimate goal of helping as many children as possible learn to read adequately and return to general education."

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