Archive for Merck

Toyota 52 deaths, Gardasil 49. Toyota recalled.

Posted in Gardasil, Vaccinations with tags , , , , , , , , on April 7, 2010 by saynsumthn

Barbara Hollingsworth: Time for the truth about Gardasil
By: Barbara Hollingsworth
Local Opinion Editor
March 30, 2010

Cervical cancer accounts for less than 1 percent of all cancer deaths, so it was somewhat surprising when the U.S. Food and Drug Administration fast-tracked approval of Gardasil, a Merck vaccine targeting the human papilloma virus that causes the disease, in 2006.

As of Jan. 31, 2010, 49 unexplained deaths following Gardasil injections have been reported to the Centers for Disease Control and Prevention’s Vaccine Adverse Event Reporting System (http://vaers.hhs.gov/index). By contrast, 52 deaths are attributed to unintended acceleration in Toyotas, which triggered a $2 billion recall.

No recall for Gardasil, which is required for sixth-grade girls in D.C., Maryland, Virginia, and many other states. Parents can opt out, but few know the true risks.
That was the certainly the case for Mary Davison of Frederick, Md., whose three daughters had the second of a three-shot vaccination regimen in January 2008. Her two younger girls had no reactions, but 20-year-old Mary Katherine felt sick and dizzy.

A subsequent magnetic resonance imaging scan showed that the Hood College student had a major stroke, and she spent almost two months in rehab before she could walk again. However, it wasn’t until the family’s primary care physician refused to schedule Mary Katherine’s third injection that her mom “finally put two and two together,” she told the Washington Examiner.

A month later, Lisa Ericzon of Alexandria Bay, N.Y., found her 17-year-old daughter Jessica dead on the bathroom floor just 40 hours after her third Gardasil injection. The coroner listed the cause as “undetermined natural causes.”

Jessica had pain and dizziness following her second Gardasil shot. “At the time, we didn’t think about any connection with the vaccination,” Ericzon told me. “But later, when I got on the Internet, I found all of the side effects Jessica complained about and three other women told me their daughters had also died within days of being vaccinated.”

One of those women was Emily Tarsell, of Sparks, Md., whose 21-year-old daughter Christina died 18 days after receiving her final Gardasil injection and experiencing fatigue, dizziness, and a pounding heartbeat. “We had no clue that these were all symptoms of something,” her mother said. Neither an autopsy or toxicology screen could determine the cause of death.

An October 2008 CDC report said 28 million girls and women who received Gardasil had no more adverse medical outcomes than those who hadn’t gotten the shots. But in February 2009, the National Vaccine Information Center (nvic.org) used CDC’s own data to contradict the government’s findings: Gardasil was associated “with at least four times as many death and cardiac arrest reports” as a similar vaccine, and “seemed to be associated with an unusually high number of reports of atypical collapse. …”

The August 2009 Journal of the American Medical Association reported that 89 percent of adverse Gardasil reactions submitted to VAERS had “insufficient identifying information to permit clinical follow-up or review.”

Merck denies any of the deaths are related to its vaccine, and the parents involved can’t prove they were. A Merck spokeswoman would only refer me to the VAERS Web site.
“CDC is still saying this is a safe vaccine. With Pap smears, there was no medical reason for fast-tracking FDA approval. They made it sound like it was some kind of pandemic,” Tarsell added. “No one ever calls you, no one ever follows up.”

Indeed, two months after Sen. Barbara Mikulski, D-Md., asked CDC to contact Tarsell, she has yet to hear from them. The feds “totally ignored us,” echoed Ericzon.
Barbara F. Hollingsworth is the Washington Examiner’s local opinion editor.

Read more at the Washington Examiner: http://www.washingtonexaminer.com/opinion/columns/Time-for-the-truth-about-Gardasil-89466882.html#ixzz0kRpedz85

Rotarix rotavirus vaccine contaminated, officials say

Posted in Vaccinations with tags , , , , , , on March 26, 2010 by saynsumthn

By Tom Watkins, CNN
STORY HIGHLIGHTS

* Doctors have been advised to suspend use of Rotarix rotavirus vaccine
* Another vaccine, RotaTeq, is still OK to use, officials say
* GlaxoSmithKline, maker of Rotarix, says the contamination is not harmful

(CNN) — Federal health authorities recommended Monday that doctors suspend using Rotarix, one of two vaccines licensed in the United States against rotavirus, saying the vaccine is contaminated with material from a pig virus.

“There is no evidence at this time that this material poses a safety risk,” Food and Drug Administration Commissioner Dr. Margaret Hamburg told reporters in a conference call.

Rotarix, made by GlaxoSmithKline, was approved by the FDA in 2008. The contaminant material is DNA from porcine circovirus 1, a virus from pigs that is not known to cause disease in humans or animals, Hamburg said.

About 1 million children in the United States and about 30 million worldwide have gotten Rotarix vaccine, she said.

Rotavirus disease kills more than 500,000 infants around the world each year, primarily in low- and middle-income countries, she said. Before rotavirus vaccine became available, the disease was blamed for more than 50,000 hospitalizations and several dozen deaths per year in the United States, she said.

The FDA learned about the contamination after an academic research team using a novel technique to look for viruses in a range of vaccines found the material in GlaxoSmithKline’s product and told the company, Hamburg said. The drug maker confirmed its presence in both the cell bank and the seed from which the vaccine is derived, suggesting its presence from the early stages of vaccine development, she said. The FDA then confirmed the drug maker’s findings.

GlaxoSmithKline emphasized Monday that the pig virus is not known to cause illness in humans, saying “it is found in everyday meat products and is frequently eaten with no resulting disease or illness.”

“No safety issue has been identified by external agencies or GSK,” Thomas Breuer, the drug maker’s chief medical officer, said in a written statement. “GSK is committed to patient safety and to the highest manufacturing standards for all our vaccines and medicines. We are already working closely and discussing this finding with regulatory agencies around the world.”

Another vaccine, RotaTeq, is made by Merck and was approved in 2006. There is no evidence that the Merck product is affected, Hamburg said. Both vaccines are given by mouth to infants to prevent rotavirus disease, which is marked by severe diarrhea and dehydration.

Asked whether Merck would be able to meet the nation’s demand, Merck spokeswoman Pam Eisele said, “Obviously, we will work with the … FDA to evaluate supply needs.”

In the next four to six weeks, the drug agency will convene an advisory committee to make recommendations and seek input on the use of new techniques for identifying viruses in vaccine, Hamburg said.

“We’re not pulling it from the market, we’re just suspending its use during this period while we’re collecting more information,” she said. “It should not be in this vaccine product and we want to understand how it got there. It’s not an easy call and we spent many long hours debating the pros and cons but, because we have an alternative product and because the background rates of this disease are not so severe in this country, we felt that the judicious thing to do was to take a pause, to really ask the critical questions about what this material was doing in the vaccine, how it got there.”

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, said “a substantial amount” of the DNA was found in the vaccine. But, he stressed, “there is no evidence that it causes any disease. … There is no evidence that it ever does anything.”

The research group that discovered the contamination has asked not to be identified pending its paper’s publication in a scientific journal, Hamburg said.

Anyone who has already received a dose of Rotarix should switch to the Merck product for the next two doses, Hamburg said. Preliminary testing of the Merck product has found no evidence of the porcine circovirus 1 DNA, she said. Doctors should be able to tell parents which of the two products their children received, she said.

Hamburg stressed that the suspension applies only to the United States. Public health officials in countries where the incidence of rotavirus is more severe may decide that the benefits of continuing to use the vaccine outweigh any concerns raised by the contamination, she said. “Such a decision would be very understandable,” she added.

A similar virus, porcine circovirus 2, also does not cause disease in humans, but it does cause disease in its pig host, Hamburg said.

High Potential for False Safety Concerns with H1N1 Vaccine

Posted in Alex Jones, Civil Rights, Flu Chip, Flu Shot, Glenn Beck, H1N1, Health Care, Homeland Security, Mercury, Population Control, Swine Flu, Vaccinations, Veri-Chip with tags , , , , , , , , , , , , , , , , , , , , , , on November 2, 2009 by saynsumthn

From Medical News:

Failure to account for background rates when considering adverse events from pandemic H1N1 flu vaccination could spark public panic, researchers cautioned.
Coincidental cases of dramatic events including sudden death, Guillain-Barré syndrome, and spontaneous abortion can be expected to boost the true incidence of adverse events after immunization, said Steven Black, MD, of Cincinnati Children’s Hospital, and colleagues online in The Lancet.

The public will need frequent reassurance of vaccine safety when events that are temporally associated with vaccination are identified, even when these events have other causes and occur at the expected background rate,” they said.

Widespread belief in spurious associations can disrupt immunization programs, the researchers noted.

They cited the example of four deaths that occurred within 24 hours of seasonal flu vaccination in 2006 in Israel that derailed the program there, even though these were high-risk patients to begin with and the number of deaths was actually lower than expected from chance alone.

The risk is high for a similar situation with the mass vaccination programs underway for H1N1 influenza, they said.

A vaccination campaign in 1976-1977 against “swine” flu was associated with elevated rates of the autoimmune disease Guillain-Barré syndrome.

Since one or two diagnoses of the syndrome per 1 million people would be expected every month, 200 or more cases of Guillain-Barré will occur as background, coincidental events during the current vaccination campaign if 100 million people in the U.S. are immunized.

The reporting of even a fraction of such a large number of cases as adverse events after immunization, with attendant media coverage, would probably give rise to intense public concern, even though the occurrence of such cases was completely predictable and would have happened in the absence of a mass campaign,” Black’s group wrote.

So, the investigators looked into background rates of some events that are most likely to raise concerns with the pandemic vaccination campaign.
A review of data from prior studies and from hospital databases showed that rates varied by year, country, age, and sex.

Overall, 3.58 cases of Guillain-Barré syndrome would be expected as background events within seven days per 10 million individuals vaccinated and 21.50 per 10 million within six weeks.

Coincident sudden death would be expected to strike 0.98 people per 10 million vaccinated people within seven days of vaccination and 5.75 cases would be expected to occur within six weeks as background events.

Among women, 14.40 cases of optic neuritis would be expected for every 10 million vaccinated within seven days and 86.30 could be expected for the same population within six weeks.

For pregnant women, 397 spontaneous abortions within one day of vaccination would occur as coincidental, background events for every 1 million vaccinated.

However, the researchers cautioned that the miscarriage rate may have been an overestimate given that vaccination rates are not uniform throughout trimesters of pregnancy.

But given the large number of events that could potentially be misinterpreted as caused by vaccination, Black’s group recommended “timely and thorough analysis of safety concerns,” taking into account the chance of temporal and geographical clustering.

For example, about 2% of practices will likely have a seemingly elevated rate — more than two standard deviations above average — of post vaccination spontaneous abortion based on the normal distribution.

Although this could lead to suspicions of a link to vaccination or a specific manufacturer’s vaccine, the investigators warned that “even random events can appear to have patterns.”

The number of cases sent to passive reporting systems alone is not an appropriate method on which to rely because the “denominator” — the number vaccinated — is usually not known, they cautioned.

Comparing observed and expected rates is a better method, although that is still subject to uncertainty and differences in populations, the researchers said.
In the U.S., the voluntary Vaccine Adverse Event Reporting System has beefed up outreach efforts, and a new Web-based active surveillance system has been implemented along with population-based, computerized database monitoring, according to an accompanying commentary in The Lancet.

The CDC’s Frank DeStefano, MD, MPH, and Jerome Tokars, MD, MPH, wrote that other countries have mounted similarly intensive monitoring for the safety of the H1N1 vaccine, which should serve as a model for tracking safety of all vaccines in the future.

Black reported serving on the data monitoring safety board for pneumoccocal conjugate vaccine for GlaxoSmithKline and receiving honoraria for participation in scientific advisory boards for Novartis. Co-authors reported conflicts of interest with the CDC, Merck, Novartis, Wyeth, and Sanofi Pasteur.

DeStefano and Tokars reported no conflicts of interest.

Primary source: The Lancet
Source reference:
Black S, et al “Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines” Lancet 2009; DOI: 10.1016/S0140-6736(09)61877-8.

Also Read: Pregnant Women Wary of Swine Flu Shot

Oct. 27, 2009 — A new survey shows only about one in four pregnant women and mothers of young children plan to get the H1N1 flu vaccine this year, despite recommendations from public health groups urging them to do so.
The CDC, American College of Obstetrics and Gynecology, and many other public health organizations strongly recommend that pregnant women and new mothers get both the seasonal and H1N1 flu vaccine shots to protect themselves as well as their newborns.
The survey shows 43% of pregnant women and mothers of children younger than 2 years old plan to get a seasonal flu shot this year, up from 33% surveyed last year. But only 27% plan on getting the H1N1 flu vaccine.
Researchers say confusion and concerns about the safety and effectiveness of the H1N1 vaccine may be preventing many pregnant women from getting the additional protection they need…..

Top researcher who worked on cervical cancer vaccine warns about its dangers

Posted in birth control, Gardasil, Health Care, Planned Parenthood, pro-choice, Vaccinations, Violence against women with tags , , , , , , , on October 9, 2009 by saynsumthn

by Mike Adams, the Health Ranger, NaturalNews Editor

harper
(NaturalNews) One of the key researchers involved in the clinical trials for both Gardasil and Cevarix cervical cancer vaccines has gone public with warnings about their safety and effectiveness. This highly unusual warning against these vaccines by one of Big Pharma’s own researchers surfaced in an exclusive interview with the Sunday Express in the UK over the last few days. There, Dr. Diane Harper openly admitted the vaccine doesn’t even prevent cervical cancer, stating, “[The vaccine] will not decrease cervical cancer rates at all.”

This is astonishing news. The whole push behind the cervical cancer vaccines is based on the belief that they prevent cervical cancer. That belief, it turns out, is a myth.

Dr. Harper also warned that the cervical cancer vaccine was being “over-marketed” and that parents should be warned about the possible risk of severe side effects from the vaccine. She even concluded that the vaccine itself is more dangerous than the cervical cancer it claims to prevent!

Hysteria over genital warts?
In a New York Times article published last year, Dr. Harper spoke about the fear-based marketing of Gardasil by Merck:

“‘Merck lobbied every opinion leader, women’s group, medical society, politicians, and went directly to the people — it created a sense of panic that says you have to have this vaccine now…”

This behavior by drug companies — using fear tactics to promote a particular disease in order to sell the “treatment” — is called disease mongering. Most of the pharmaceutical profits generated today are based on precisely this tactic: Spread the fear, then sell the treatment.

Why is disease mongering so important to the profits of the drug companies? They figured out many years ago that selling drugs only to those people who are sick was a very limited income opportunity. To rake in the real profits, they needed to devise a way to sell drugs to healthy people (i.e. people who don’t need them). That’s what cervical cancer vaccines really are: A scheme to sell vaccines to people who aren’t suffering from any disease at all.

That one of the industry’s own researchers is willing to speak out against this is not just highly unusual; it’s also highly courageous. It makes you wonder: Who, exactly, is this Dr. Harper?

Dr. Diane Harper
Dr. Harper is a graduate of the Massachusetts Institute of Technology. She studied additional courses at Stanford and received her medical degree from the University of Kansas. She was a key researcher in both Gardasil and Cervarix vaccines, and she’s one of the most experienced researchers in the world on HPV-related diseases. She’s done work for both Merck and GlaxoSmithKline.

Dr. Harper’s warnings about cervical cancer vaccines are especially relevant considering her expertise in the cost/benefit analysis of vaccines. Her conclusion is that cervical cancer vaccines aren’t worth the risks, nor are they worth all the effort being put into hyping them to the public. “This may not be the best use of our resources at this time,” she said in a Washington Post article.

So why do cervical cancer vaccines continue to be pushed by doctors and health authorities across the US, UK and other first-world nations? Because Big Pharma is the great corporate puppeteer that’s pulling the strings of legislators. With enough money and lobbyists, you can always overcome scientific thinking with fear-based marketing and under-the-table deal-making. Science-based medicine has no place in a world where disease is big business.

There’s a ridiculous amount of money to be made by pushing vaccines onto people who don’t need them. If I had ten bucks for every teenage girl that’s been injected with a cervical cancer vaccine, I’d be… well… GlaxoSmithKline.