Friday, November 23, 2007



HPV virus: Give your little girl VACCINES if you are stupid


The Ottawa Citizen

Half Ontario parents refuse HPV vaccine: health official

Charlie Fidelman, The Montreal Gazette
Published: Thursday, November 22, 2007

The Ontario vaccine program that started this fall is floundering, a leading health official said yesterday.

"There are lessons to be learned from the Ontario experience. You don't want to undermine the program before you start," said Dr. Ian Gemmill, the medical officer of health for Kingston, Frontenac and Lennox & Addington Public Health.

Parents are refusing Gardasil, a newly-developed vaccine to prevent human papillomavirus (HPV), a sexually-transmitted infection that is identified as the major cause of cervical cancer.

"It's not something that typically we've seen with any other vaccine program we've had," said Dr. Gemmill, who has served on national and provincial committees on communicable diseases and immunization.

Fewer than 50 per cent of parents -- in some Ontario areas it's 28 per cent -- have agreed to vaccinate their girls, Dr. Gemmill told a conference on public health held in Montreal.

"This is a huge disappointment," said Dr. Gemmill, who blames popular media and scientific journals for stoking unfounded fears of the vaccine.

The federal government is making available $300 million to the provinces for HPV vaccination.

Ontario's announcement that it will offer a vaccine to girls in Grade 8 came in August, a day after an article in the Canadian Medical Association Journal argued it is premature to offer the immunizations on a universal basis.

Lead author and McGill University epidemiologist Abby Lippman warned that the long-term effects of the Gardasil vaccine are not known.

Ms. Lippman argued that the disease isn't an epidemic and regular Pap tests are effective in detecting cervical cancer in early, treatable stages.


A warehouse manager takes a carton of Tamiflu, which contains the antiviral drug oseltamivir, for packing at a pharmaceuticals storage facility in Singapore March 21, 2007. U.S. Food and Drug Administration staff are recommending new warnings about psychiatric events observed in patients on Roche Holding AG's (Nicky Loh/Reuters)

Yahoo Main Page (Most Popular in the World)

FDA staff urge warnings for two flu drugs

By Kim Dixon 12 minutes ago
Nov 23, 2007

WASHINGTON (Reuters) - Food and Drug Administration staffers are recommending new warnings about psychiatric events observed in some patients taking Roche Holding AG's Tamiflu and GlaxoSmithKline Plc's Relenza, according to documents released on Friday.

An FDA advisory panel will review the recommendations for the anti-viral influenza drugs at a meeting next week.

The FDA held a similar meeting two years ago in response to reports of a dozen deaths of children in Japan who had been taking Tamiflu.

Experts then found no evidence of a direct connection between the drug and the deaths, although the FDA did ultimately update Tamiflu's label to add a caution urging close monitoring of patients for abnormal behavior such as delirium or self-injury.

In documents prepared for the meeting next week and posted on the FDA's Web site, agency staff recommended that Tamiflu's label be strengthened to note: "In some cases, these behaviors resulted in serious injuries, including death, in adult and pediatric patients."

The FDA staff also reviewed Relenza, a drug in the same class as Tamiflu, recommending its label be changed to note "reports of hallucinations, delirium and abnormal behavior" observed in some patients taking the drug.

The current Relenza label has no label warning related to psychiatric events.

The FDA staff said the evidence is "conflicting" as to whether the events are medication-related, a manifestation of disease or a combination of the two.

Tamiflu has been more widely used in Japan than in the United States, and there is some evidence that the Japanese are more vigilant about reporting side effects, the FDA has said.

Tamiflu, known generically as oseltamivir, is a pill, while Relenza, generically zanamivir, is inhaled.

A Roche spokesman said no causal relationship between Tamiflu and these psychiatric events has been proven.

"Roche has extensively investigated the issue and is conducting ongoing clinical and nonclinical studies. Roche takes all adverse events reports very seriously," spokesman Terence Hurley said in a statement.

About 48 million people have taken Tamiflu worldwide, including 21 million children, since approval in 1999, he said.

A Glaxo spokeswoman said a review of premarketing and post-approval trial data showed no worrying safety signals on patients taking Relenza. The drug is a not a major revenue-generator for UK-based Glaxo.

FDA staff based its recommendations on a review of nearly 600 cases of neuropsychiatric events reported by patients on Tamiflu and 115 cases of such events by patients taking Relenza.

The FDA staff will present the advice to the advisory panel of experts meeting on Tuesday, November 27. The agency typically takes the advice of these panels but is not bound by them.


Japan in March warned against prescribing Tamiflu to those ages 10 to 19 as more than 100 people, mostly young, showed signs of abnormal behavior after taking the drug.

Earlier this year, Japan broadened its probe of Tamiflu to look at flu drugs Relenza and amantadine, after reports of abnormal behavior among young patients.

FDA staff reviewed recent side effect reports on amantadine and rimantadine, another flu drug in amantadine's class, but recommended no label changes. Amantadine already has a strong warning about suicide attempts and an increase in seizures seen in patients on the drug, while rimantadine notes seizure-like activity and hallucinations.

Tamiflu was having lackluster sales as a drug to prevent and treat seasonal flu but got a second life when it was the first drug to show real efficacy in treating and preventing bird flu.

The FDA staff documents for the advisory meeting were posted at: dex-27and28.html.

(Additional reporting by Ben Hirschler in London)

(Reporting by Kim Dixon; Editing by Gerald E. McCormick and Carol Bishopric)

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Rolling Stone Magazine

Deadly Immunity

Robert F. Kennedy Jr. investigates the government cover-up of a mercury/autism scandal

Posted Jun 20, 2005 12:00 AM

In June 2000, a group of top government scientists and health officials gathered for a meeting at the isolated Simpsonwood conference center in Norcross, Georgia. Convened by the Centers for Disease Control and Prevention, the meeting was held at this Methodist retreat center, nestled in wooded farmland next to the Chattahoochee River, to ensure complete secrecy.

The agency had issued no public announcement of the session -- only private invitations to fifty-two attendees. There were high-level officials from the CDC and the Food and Drug Administration, the top vaccine specialist from the World Health Organization in Geneva and representatives of every major vaccine manufacturer, including GlaxoSmithKline, Merck, Wyeth and Aventis Pasteur.

All of the scientific data under discussion, CDC officials repeatedly reminded the participants, was strictly "embargoed." There would be no making photocopies of documents, no taking papers with them when they left.

The federal officials and industry representatives had assembled to discuss a disturbing new study that raised alarming questions about the safety of a host of common childhood vaccines administered to infants and young children.

According to a CDC epidemiologist named Tom Verstraeten, who had analyzed the agency's massive database containing the medical records of 100,000 children, a mercury-based preservative in the vaccines -- thimerosal -- appeared to be responsible for a dramatic increase in autism and a host of other neurological disorders among children. "I was actually stunned by what I saw," Verstraeten told those assembled at Simpsonwood, citing the staggering number of earlier studies that indicate a link between thimerosal and speech delays, attention-deficit disorder, hyperactivity and autism.

Since 1991, when the CDC and the FDA had recommended that three additional vaccines laced with the preservative be given to extremely young infants -- in one case, within hours of birth -- the estimated number of cases of autism had increased fifteenfold, from one in every 2,500 children to one in 166 children.


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