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News 8 Investigates: Prevnar-Part 1

DALLAS, Feb 21  - By the time our children are old enough to go to school in this country we have given them nearly 40 doses of vaccines.  In 1940, children received just nine doses of vaccines. News 8's Valeri Williams begins an investigation into the questionable science behind the federal government's vaccine approval process. And what parents should know about the latest vaccine on the market, Prevnar.

"He-man took it with a smile as they participated in the experiment that could end the menace of polio," said a clip from an old film. 


This is NOT a report about vaccines being bad.

In the past 50 years, they have helped us to eradicate polio, small pox and whooping cough just to name a few dreaded childhood diseases.

But as the number of vaccines grows in this country so do the profits for the pharmaceutical companies who manufacture them.

Consumer advocates say here's what getting government approval for just one
vaccine can mean:

"The vaccine manufacturer of a new vaccine that's added to the universal use list has an assured stable market of three-and-a-half to four million babies born in this country every year. As of 1986, the manufacturer has virtually no liability for adverse events that may occur as do the doctors who administer the vaccine as of 1986. No liability. Stable-made market. No liability. A stockholder's dream," said Barbara Loe Fisher of the National
Vaccine Information Center.

This little vial holds one of the latest vaccines to be licensed by the FDA.

It's called Prevnar and since last March, there have been 10-million doses distributed.

At about $60-per-injection, there are a series of four shots, this is one of the most expensive vaccines in history.

"I had a baby that was perfectly healthy, happy, okay until she got a shot, until she got her vaccine, remembered parent Ray Graves.

Hayley Graves was nine months old when she received her second dose of Prevnar. This picture was taken the day she got her injection.

"Thirty, forty hours later, she's in the hospital having seizures that they can't stop. You're not gonna tell me it's not related to the vaccine somehow," said Graves.

Hayley slipped in and out of a coma for 45 days until she died in September. Tremors shook her little body almost the entire time.

"It's hard, it's very hard," said Graves.

Like many parents, Ray and Lisa Graves were told by their pediatrician that Prevnar would help to prevent "otitis media"-- or in layman's terms—ear infections.

But News 8 has discovered during a four-month investigation that Prevnar was never licensed for that use.

In fact, clinical trials showed that overall Prevnar decreased a child's chance of getting an ear infection by only 6% as compared to children who did not get the vaccine.

"I don't think anybody believes the vaccine was developed to prevent otitis," said Dr. John Modlin, chairman of the CDC Vaccine Advisory Committee.

Dr. Modlin confirmed that he knew this to be the case during an interview last week.

So 'why' we wondered had the Centers for Disease Control put out this fact sheet last March telling parents that among those who benefited most from Prevnar were:


"Children who have frequent or serious ear-aches." "I think what you're focusing on here is um.. is um ... I think you're creating basically a tempest in a teapot here," said Dr. Modlin.

But the misinformation from federal regulators doesn't stop there.

Doctors who log onto the CDC's website for Continuing Education Credit are given this test question which asks:


"Which type of pneumococcal disease is the Prevnar vaccine effective in preventing?
The correct answer according to the CDC is "all of the above"... including "acute otitis media".

Dr. Erdem Cantekin is one of the nation's leading experts on ear aches.

"It is an ineffective and toxic vaccine," said medical researcher Dr. Cantekin.

Cantekin says not only are federal regulators putting out bad information, they're also not revealing some of Prevnar's dangerous side effects.

Like seizures, which Cantekin says a study by the vaccine's manufacturer shows happened four times more often in infants given vaccines with Prevnar than children in a control group.

"I think the FDA approval of this vaccine is an act of irresponsibility. I think the FDA is following their regular course. They ignore the warnings until many people die, and then, it becomes such a public outrage and public problem, they say, "Oops, we will take this thing off the market," said Dr. Cantekin.

Before licensing Prevnar last year, vaccine committees from both the FDA and the CDC dismissed the data on seizures as not signficant.

However, as part of our investigation, News 8 reviewed nearly 800 adverse reaction reports filed with the FDA during past nine months.

What we found is that one of out 10 children who had suspected side effects suffered some sort of seizure.

"I'm angry..or I'm not angry, I'm mad.. that's all there is to it. You know, I guess I'm a little bitter about losing a child. I'm not a little, I'm a lot bitter," said Graves.

The Graves have no absolute proof that Prevnar killed their daughter.. just a string of medical coincidences.

Wyeth Laboratories, which makes Prevnar, says it has received a small number of reports about seizures among patients who've received the vaccine.

The company declined to interview with News 8, but it did fax us this letter which says:


"These reports are consistent with data from clinical trials documenting seizures in children who did not receive Prevnar. While there have also been a small number of deaths coincident with Prevnar administration, there is no reason to conclude that there is any association between these deaths and the administration of Prevnar. Prevnar... was tested in hundreds of thousands of children prior to its approval by the FDA."  Once you assume that a certain number of children are expendible, it is a very slippery slope. Because then, how many, how many can you sacrifice? Is it five? Is it a 100? Is it 5,000? It's very dangerous to employ that kind of utilitarian rational," said Fisher.

So if Prevnar was not licensed for ear infections... exactly what was it approved for?

To fight some strains of pneumococcal meningitis, pneumonia, and bacterimia.

But last year, there were only 1500 cases of pneumococcal meningitis in infants in this country.

Critics say not enough of a threat to scare parents into getting the vaccine, but tell parents that this ear ache vaccine... and there are five million cases of ear infections in children each year ... suddenly that produces a lot more interest.

Thursday night News 8's Valeri Williams will look into the stocks, grants or contracts that the people who sit on the vaccine committees have with the pharmaceutical industry.

It's called "conflict of interest".

By: Valeri Williams
Copyright:  2001 by WFAA-TV Co. All Rights Reserved.
 

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Copyright 2000 by WFAA-TV Co., A Belo Subsidiary

 

Breaking News Archives - each day's breaking news from December 1, 2003 (check here for breaking news you might have missed and breaking news that didn't ever hit the "front page")

More News - all the news most recently posted on this website

All the News - a running tab of everything posted on this website since October 29, 2003

Top Stories Archives - daily breaking and other important news stories

Daily News Archives - all the news posted on this website each day (from April 2001)

Hot Topics - selected stories, by category

Return to Vaccination News Home Page (for best results, right click to "open in new window")

DISCLAIMER:    All information, data, and material contained, presented, or provided here is for general information purposes only and is not to be construed as reflecting the knowledge or opinions of the publisher, and is not to be construed or intended as providing medical or legal advice.  The decision whether or not to vaccinate is an important and complex issue and should be made by you, and you alone, in consultation with your health care provider.