Doctors Ask Congress To Probe Vaccine Approval Process / VAX Media News

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Doctors Ask Congress To Probe Vaccine Approval Process / VAX Media News

Saturday, September 04, 1999

(Reuters Health) -- The Association of American Physicians and Surgeons

(AAPS) on Thursday requested that Congress investigate the approval process

for all vaccines after the rotavirus vaccine was shown to threaten the life

of 15 infants who received the vaccine.

The rotavirus vaccine was recently withdrawn from the market after it

was revealed that 15 infants were diagnosed with the intestinal disorder

intussusception after receiving the vaccine. Furthermore, the rate of

intussusception, or intestinal obstructions, during clinical trials was 30

times the expected rate, according to the association's review of trial

records.

" The situation with the rotavirus vaccine may be a clue to a far more

serious problem with the vaccine approval process, " the association's

Executive Director Dr. Jane M. Orient, said in a letter to Rep. Dan Burton,

who chairs the House Committee on Government Reform and Oversight. " AAPS has

been studying the reports and has concluded that the FDA (Food and Drug

Administration) and CDC (Centers for Disease Control and Prevention) may

have ignored or concealed data that showed the problems from the outset.

House Committee spokesman told Reuters Health that the

investigation is ongoing. Committee investigators initiated a probe this

spring into the approval process for a range of vaccines, he said.

Physicians and parents were not warned to watch for symptoms of

intussusception, Orient said in a press statement. As a result the

association is also calling for public disclosure of the approval process

and independent review of data.

The CDC did not return Reuters' phone call by deadline. However, the

association reports that the CDC Web site, dated March 23, said, " In studies

that have been done so far, rotavirus has been associated only with mild

problems. "

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VAX Media News:

Kathi of the National Vaccine Information Center reports that

the " Director MS-NBC has contacted us with the good news that the vaccine

story that ran on August 27, 1999 will be re-aired on Monday September 6,

1999. It will air at 10:00 PM on CNBC. This is one of the highest rated

segments they have ever done. When it aired at 9:00 PM there was a ratings

jump during the segment. When it aired at 10:00 PM there was another ratings

surge. . .Parent Activist Rick Rollens joins in with " Look for one of many

articles I am involved in coming out this Monday, September 6 in Newsweek

Magazine. The vaccine-autism story will be with us in the press for many

months to come.

The CDC's " IMMUNIZATION UPDATE, " is Sept. 16, 1999

You still have time to register! The Centers for Disease Control and

Prevention (CDC) will sponsor " Immunization Update, " a live, interactive,

satellite videoconference on September 16, 1999. The broadcast will provide

the most current information available in the constantly changing field of

immunization. Continuing education credits will be offered for a variety of

professions.

Topics covered will include new recommendations for polio vaccination

in the United States, expanded recommendations for the use of hepatitis A

vaccine, characteristics and use of Lyme disease vaccine, and recent vaccine

safety issues. Each 2.5 hour broadcast will feature a question and answer

session in which participants nationwide can interact with the course

instructors via toll-free telephone lines.

L. Atkinson, MD, MPH, and Sharon G. Humiston, MD, MPH, medical

epidemiologists at the National Immunization Program, will host the

broadcast along with other guest experts from CDC.

Two broadcasts of " Immunization Update " are schedule on September 16th,

1999. The first broadcast will run from 9:00-11:30 a.m. (ET), and the second

from 12:00-2:30 p.m. (ET).

For more information, call 888-232-3299 and request fax document

#130022, or click here:

http://www.cdc.gov/phtn/fact-sheets/Imm-99/130022.htm

To register for the course, or to find out viewing locations, contact

your state immunization program manager. Find his/her phone number at:

http://www.cdc.gov/phtn/stcoords.htm

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editor: Lenny Schafer east coast editor: , Ph.D.

schafer@... CIJOHN@...

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