Wednesday, March 01, 2006

Blockbuster Vaccine RotaTeq


Kids Die and people lie,
and vaccines'll really hurt'cha

All the news about the six-month anniversary of Katrina, and the lack of progress towards rebuilding, the lives ruined and resources lost, reminds us of how little our government really can do in the face of calamity. A lot of the little that is done is a willing oversight by the powers that be, who have more concern for their own continuation in power, than what that power can provide for the common good.

The approval of a new vaccine for children by a federal advisory committe is a case in point of unbridled power used to line the pockets of the mega-rich:

Every healthy newborn in the United States should receive a new vaccine designed to protect against an intestinal germ called rotavirus, a federal advisory panel decided yesterday as it set aside theoretical concerns about the vaccine's safety.

The decision means that pediatricians are likely to recommend three doses of the oral vaccine for nearly every child at age 2 months, 4 months and 6 months, beginning almost immediately. The vaccine won approval from the Food and Drug Administration on Feb. 3, and some doctors have received supplies of it.

The recommendation for universal use of the vaccine was approved at a meeting of the Advisory Committee on Immunization Practices, the federal panel that sets vaccination policy in the United States. It comes nearly seven years after an earlier rotavirus vaccine was withdrawn from the market for causing a potentially life-threatening form of intestinal blockage in some babies.

Vaccine-safety advocates are urging parents to be wary of the new vaccine because of that history. The federal Centers for Disease Control and Prevention and the manufacturer, Merck & Co. Inc. of Whitehouse Station, N.J., have promised elaborate studies to catch any safety problems. Merck is selling the vaccine under the brand name RotaTeq.--
Washington Post 2/22/06

Our friend and watchperson at the Nationa Vaccine Information Center (NVIC.org), Barbara Loe Fisher, has a very different take on the rotavirus vaccine and its concurrent dangers and cost:

Infant diarrhea, properly managed, rarely fatal in the US and children whorecover from rotavirus infection have immunity.

Merck's live rotavirus vaccine (RotaTeq) contains five human-bovine (cow)reassortment rotaviruses. Stanley Plotkin, M.D., Fred Clark, D.V.M., Ph.D.,and Paul Offit, M.D.are U.S. and international patent holders of thevaccine. Offit and Clark are on the faculty of the Children's Hospital ofPhiladelphia. Plotkin is also a patent holder of the rubella vaccine and isassociated with the Wistar Institute.

By adding a diarrhea (rotavirus) vaccine to the routine childhood vaccineschedule, American children will now be subjected to 57 doses of 15 vaccinesby age 12. By 8 weeks old, an infant will have received 9 doses of 8 vaccines and 8 of those doses can be given on a single day.

Were there long term studies of RotaTeq in combination with 7 othervaccines? Was there an evaluation of antibody response and adverse eventsrelative to genetic or other biological differences between children? Wasthere any long term follow up to determine whether there are long termnegative effects on the developing immune system and brain of infants whenthey are given RotaTeq along with 7 other vaccines on a single day twice inthe first four months of life and once with 8 other vaccines on a single dayat age 6 months - compared to infants who receive no vaccines at all?

The answer is no.

Whether or not people have received the flu vaccine, they get the flu in the same numbers more or less every year. The year there was a huge flu vaccine shortage two years ago saw a smaller amount of flu cases than normal. Kids get pertussis--whooping cough--whether of not they received the vaccine. Some vaccines, like measles, do give short-term immunity, unlike the disease which confers lifelong immunity in most cases.

There are doubts and controversies surrounding the vaccine program in this country. There is no doubt about the money to be made from vaccines for their manufacturers, and that's the emmes.

RotaTeq is expected to be one of the most expensive vaccines ever marketed, with Merck listing it at $187.50 wholesale for the three-dose series. That means many doctors are likely to charge more than $300 retail, putting the Merck product in league with Prevnar, an expensive Wyeth vaccine that has been widely used in the United States for five years.

Prevnar, which protects children against certain types of pneumonia, became the first vaccine to meet the pharmaceutical industry's standard for a blockbuster product, with sales exceeding $1 billion a year.--Washington Post 2/22/06

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