2. MMR/Vaccine Report Finds No Provable Connection But Calls for Research

[Guest guest]

FEAT DAILY NEWSLETTER Sacramento, California http://www.feat.org

" Healing Autism: No Finer a Cause on the Planet "

______________________________________________________

April 23, 2001 Search www.feat.org/search/news.asp

2. MMR/Vaccine Report Finds No Provable Connection but Calls for Research

Continued from previous post.

SIGNIFICANCE ASSESSMENT

In its significance assessment, the committee considered the burden

(i.e., the seriousness, risk, and treatability) of the vaccine-preventable

diseases (measles, mumps, and rubella). The potential adverse event (ASD),

and the level of public concern surrounding this issue. Measles, mumps, and

rubella can lead to significant morbidity and mortality and treatment of

these infectious diseases and their associated complications is limited to

symptomatic relief and physiologic support until the condition resolves.

Historically, concerns about the safety of vaccines have led to

declines in immunization coverage rates followed by outbreaks of disease, as

observed with pertussis in the United Kingdom during the 1970s. Similar

outbreaks could easily occur were immunization rates to decline as a result

of fears regarding MMR. Yet, because MMR vaccine is a mandatory vaccine that

is administered to healthy children—in part, as a public health measure to

protect the health of others—the responsibility of the government to ensure

the safety of this vaccine is high, even if the adverse outcome is rare.

Thus the significance of the hypothesized adverse event—ASD, a group

of incurable and serious behavioral disorder—requires consideration of all

possible etiologies. In addition, the level of public concern about MMR

vaccine safety is high.

RECOMMENDATIONS

Public Health Response Although the committee has concluded that the

evidence favors rejection of the causal relationship at the population level

between MMR vaccine and autistic spectrum disorders, the

committee-nevertheless recommends that this issue receive continued

attention. It does so in recognition that its conclusion does not exclude

the possibility that MMR vaccine could contribute to ASD in a small number

of children, as well as the following factors: the identified limitations of

the evidence, the burden of ASD, the burden of the diseases prevented by the

vaccine, the immense and concern of parents, and the prominence of the issue

in public debate.

Specific recommendations regarding policy review, research and

surveillance, and communication follow.

Policy Review The committee does not recommend a policy review at this

time of the licensure of MMR vaccine or of the current schedule and

recommendations for administration of MMR vaccine.

Research Regarding MMR and ASD The committee concludes & at further

research on the occurrence of ASD in a small number of children subsequent

to MMR vaccination is warranted and has identified targeted research

opportunities that could lead to firmer understanding of the relationship.

The Committee makes the following research recommendations, recognizing that

it has no basis for judging whether the results of such research will alter

the balance of evidence that led to the committee's original conclusion:

• Use accepted case definitions and assessment protocols for ASD to

enhance the precision and comparability of results from surveillance,

epidemiological studies, and biologic investigations.

• Explore whether exposure to MMR vaccine is a risk factor for ASD in

a small number of children.

• Develop targeted investigation of whether or not measles

vaccine-strain virus is present in the intestines of some children with ASD.

• Encourage all who submit reports to the Vaccine Adverse Event

Reporting System to provide as much detail and as much documentation as

possible when any diagnosis of ASD is thought to be related to MMR

vaccine, • Study the possible effects of different immunization

exposures—for example, studying children whose families have chosen to have

them not receive the MMR vaccine.

• Conduct further clinical and epidemiological studies of sufficient

rigor to identify risk factors and biological markers of ASD in order to

better understand genetic or environmental causes.

Communications » The committee heard repeatedly in its open sessions

and discussions with parents and advocacy groups that obtaining unbiased and

accurate information on the possible relationship between MMR vaccine and

ASD has been difficult. The committee will address this issue more fully in

the future. In the meantime, it specifically recommends that governmental

and professional organizations, CDC and Food and Drug Administration (PDA)

in particular, review some of the most prominent forms of communication

regarding the hypothesized relationship between MMR vaccine and ASD,

including ease of access to information they provide via the Internet. They

should especially be attentive to how the material is perceived and used by

parents of children about to be immunized or those who believe their child

has been adversely affected by a vaccine. Direct input from parents and

other stakeholders would be invaluable in conducting a systematic and

effective evaluation of current communication tools.

General and Crosscutting Issues In its discussion of recommendations

related specifically to the MMR-ASD question, the committee identified more

general concerns that it could not adequately or appropriately address in

this report. These include: deficiencies in the available information on the

risks and benefits of vaccines; inadequate discussion on the ethics of

providing information regarding the risks and benefits of vaccinations; the

role of public input into vaccine advisory committees; and inadequate

clinical-provider information on vaccine safety or the Vaccine Adverse Event

Reporting System. The committee sees a need for a dialogue between vaccine

safety advocates of every kind, in order to come to common understanding of

how to align the appropriate public health attention with a possibly small

vaccine safety risk. Finally, the committee did not have time to responsibly

address the appropriateness of alternative immunization schedules or

practices, which might be requested in a clinical setting. These concerns

will be more completely considered in future reports. In the meantime, the

committee urges the CDC, PDA, NIH, American Academy of Pediatrics (AAP), and

similar organizations to take to heart the serious concerns and earnest

offers of help on information exchange and communication from the members of

the public concerned about the safety of vaccines.

SUMMARY The Immunization Safety Review Committee concludes that the

evidence favors rejection of a causal relationship at the population level

between MMR vaccine and ASD. However, this conclusion does not exclude the

possibility that MMR vaccine could contribute to ASD in a small number of

children, because the epidemiological evidence lacks the precision to assess

rare occurrences of a response to MMR vaccine leading to ASD and the

proposed biological models linking MMR vaccine to ASD, although far from

established, are nevertheless not disproved.

Because of the limitations of the evidence, the significant public

concern surrounding the issue, the risk of disease outbreaks if immunization

rates fall, and the seriousness of ASD, the committee recommends that

continued attention be given to this issue. Thus the committee has provided

targeted research and communication recommendations. However, the committee

does

not recommend a policy review at this time of the licensure of MMR vaccine

or of the current schedule and recommendations regarding administration of

MMR vaccine.

>> DO SOMETHING ABOUT AUTISM NOW <<

Subscribe, Read, then Forward the FEAT Daily Newsletter.

To Subscribe go to www.feat.org/FEATnews No Cost!

_______________________________________________________

AUTISM CONFERENCE & RALLY! WASH DC APRIL 25-27

" Open Your Eyes to Autism " and be a part of " The Power of ONE "

Unlocking Autism - www.UnlockingAutism.org

_______________________________________________________

Lenny Schafer, Editor PhD Ron Sleith Kay Stammers

Editor@... Unsubscribe: FEATNews-signoff-request@...

CALENDAR OF EVENTS submissions to Guppy events@...