Archive for GlaxoSmithKline

H1N1 WHO exaggerated threat? Influenced by drug makers ?

Posted in Flu Chip, Flu Shot, H1N1, Vaccinations with tags , , , , , , , , on June 7, 2010 by saynsumthn

Reports accuse WHO of exaggerating H1N1 threat, possible ties to drug makers
By Rob Stein
Washington Post Staff Writer

Friday, June 4, 2010; 3:52 PM

European criticism of the World Health Organization‘s handling of the H1N1 pandemic intensified Friday with the release of two reports that accused the agency of exaggerating the threat posed by the virus and failing to disclose possible influence by the pharmaceutical industry on its recommendations for how countries should respond.

The WHO’s response caused widespread, unnecessary fear and prompted countries around the world to waste millions of dollars, according to one report. At the same time, the Geneva-based arm of the United Nations relied on advice from experts with ties to drug makers in developing the guidelines it used to encourage countries to stockpile millions of doses of antiviral medications, according to the second report.

The reports outlined the drumbeat of criticism that has arisen, primarily in Europe, of how the world’s leading health organization responded to the first influenza pandemic in more than four decades.

“For WHO, its credibility has been badly damaged,” wrote Fiona Godlee, the editor of the BMJ, a prominent British medical journal, that published one of the reports. “WHO must act now to restore its credibility.”

A spokesman for the WHO, along with several independent experts, however, strongly disputed the reports, saying they misrepresented the seriousness of the pandemic and the WHO’s response, which was carefully formulated and necessary given the potential threat.

“The idea that we declared a pandemic when there wasn’t a pandemic is both historically inaccurate and downright irresponsible,” said WHO spokesman Gregory Hartl in a telephone interview. “There is no doubt that this was a pandemic. To insinuate that this was not a pandemic is very disrespectful to the people who died from it.”

The first report, released in Paris, came from the Social, Health and Family Affairs Committee of the Parliamentary Assembly of the Council of Europe, which launched an investigation in response to allegations that the WHO’s response to the pandemic was influenced by drug companies that make antiviral drugs and vaccines.

“The parliamentary assembly is alarmed about the way in which the H1N1 influenza pandemic has been handled, not only by the World Health Organization (WHO), but also by the competent health authorities at the level of the European Union and at national level,” the 18-page draft report states.

“It is particularly troubled by some of the consequences of decisions taken and advice given leading to distortion of priorities of public health services across Europe, waste of large sums of public money, and also unjustified scares and fears about health risks faced by the European public at large,” according to the report.

The second report, a joint investigation by the BMJ and the Bureau of Investigative Journalism, which is based in London, criticized 2004 guidelines the WHO developed based in part on the advice of three experts who received consulting fees from the two leading manufacturers of antiviral drugs used against the virus, Roche and GlaxoSmithKline.

“We are left wondering whether major public health organizations are able to effectively manage the conflicts of interest that are inherent in medical science,” the report states.

Hartl dismissed those charges.

“WHO would say categorically that it believes that it has not been subject to undue conflict-of-interest. We know that some experts that come to our committees have contact with industry. It would be surprising if they didn’t because the best experts are sought by all organizations,” Hartl said. “We feel that the guidelines produced were certainly not subject to undue influence.”

Several other experts also defended the agency.

“Twenty-twenty hindsight can always second guess the decisions of public health officials,” said Jeffrey Levi, executive director of the Trust for America’s Health, a private nonprofit group. “But this kind of condemnation of public health officials who made the most prudent decisions based on available knowledge could well backfire in future emergencies: I fear that public health officials will draw the lesson that they should wait for greater scientific certainty before responding in the future — and we could pay for that overcaution with many lives lost.”

In response to the criticism, the WHO has launched two investigations, including one by an independent panel of experts led by Harvey Fineberg, who heads the Institute of Medicine at the U.S. National Academy of Sciences.

These reports raise questions about potential, inappropriate influences on WHO decision-making in the assessment and response to the 2009 H1N1 pandemic and, more generally, question practices employed by WHO to guard against conflict of interest among its expert advisers,” Fineberg said in an e-mail. “These topics are among those that will be fully considered by our review committee.”

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.

Skepticism on Swine Flu’s Danger Limits European Vaccine Demand

Posted in Flu Shot, H1N1, Swine Flu, Vaccinations with tags , , , , , , , on December 9, 2009 by saynsumthn

From Bloomberg

By Andrea Gerlin

Dec. 8 (Bloomberg) — Fewer Europeans are getting pandemic flu vaccine than typically get seasonal flu shots, as safety concerns and lower-than-expected death rates have damped demand.

The U.K., Ireland, Italy, Germany and France have vaccinated less than 10 percent of their populations, compared with 20 percent in Europe in a typical flu season. As a result, a fraction of the European Union’s 500 million people will be protected against the pandemic virus by early next year.

Public concerns that the vaccines made by GlaxoSmithKline Plc, Novartis AG and Baxter International Inc. may cause serious side effects have kept some Europeans on the sidelines since governments began vaccinating residents for free in October. That means Europe may donate more doses to poorer countries or experience a surge in hospital admissions if the virus mutates.

“If it’s not in the news anymore and if people don’t experience a lot of severe cases, to them it’s just a flu and not a pandemic flu in a way,” said Christian Ruef, professor of infectious disease and director of infection control at University Hospital Zurich. “The term pandemic to them is probably associated with more serious disease.”

The number of deaths is lower than what was predicted in worst-case scenarios after the virus first struck, Ruef said. Perceptions that the virus is mild may be hampering vaccination, he said.

The European Society of Clinical Microbiology and Infectious Diseases said on Nov. 23 that it was concerned about “mixed levels of uptake” and opposition from anti-vaccine activists challenging the safety of and need for the shot. The vaccines made by London-based Glaxo, Basel, Switzerland-based Novartis and Deerfield, Illinois-based Baxter were approved for use by the European Medicines Agency.

Unpredictable Virus

“No one should reject a safe and effective vaccine when we are dealing with an unpredictable virus capable of killing children and young adults in their prime,” said Javier Garau, president of the Basel-based European Society of Clinical Microbiology and Infectious Diseases.

More than 8,768 people worldwide have died from swine flu since it was first identified in Mexico and the U.S. in April, the Geneva-based World Health Organization said on Dec. 4. More than 850 deaths have been reported in Europe since April, according to the Stockholm-based European Centre for Disease Prevention and Control. As many as 500,000 people globally die of seasonal flu each year, according to the WHO.

Officials expect the virus to be prevalent again in 2010. The WHO in September decided to include swine flu in the vaccine for seasonal influenza in the next Southern Hemisphere flu season, meaning the agency believes it’s the most likely H1N1 strain to be circulating.

Polish Negotiations

Poland hasn’t used any vaccine so far, the country’s health ministry said.

We’ve been negotiating with producers for at least a month now because we want them to guarantee the vaccine’s safe and take responsibility for any unwanted side effects, and that’s something they don’t want to do,” said Piotr Olechno, a Polish Health Ministry spokesman. The government is in talks with five companies, Olechno said. He declined to name them.

The U.K. has shipped 10 million doses of swine flu vaccine to family doctors, who have inoculated about 1.6 million of the 9.3 million people in risk groups, England’s Chief Medical Officer Liam Donaldson said Dec. 3. That’s less than 2 percent of the country’s entire population of about 60 million.

Washing Hands

To reduce the risk of catching swine flu, Emma Murphy is washing her and her toddler’s hands more often, avoiding people with colds and stocking up on honey and lemon. She and her 17- month-old son won’t get immunized.

They put the vaccine out so quickly that I wouldn’t feel secure in giving it to him,” said Murphy, 29, a human resources assistant and student in Manchester, England, in an interview. “We’re being scared into making the decision by people saying children are dying.”

Italy had immunized 494,915 people out of about 60 million who live there as of Nov. 22, according to a Dec. 2 Health Ministry press release. France, where two patients died from a mutated version of the H1N1 virus that causes swine flu, has given pandemic shots to about 1.3 million people since Oct. 20, Health Minister Roselyne Bachelot-Narquin said on Dec. 3. The French government has ordered 94 million doses of vaccine for the country’s 63 million people.

Hard Decision

Parisian Simone Cartier said she “agonized” over whether to have her daughters, ages 2 and 5, immunized against swine flu. She doesn’t know anyone who has had the illness. After reading about the vaccine, she became concerned that it was produced too quickly and contains an adjuvant, an ingredient that boosts the immune system’s response. She then spoke to her doctor and changed her mind. Two weeks ago, she waited three hours in a school gym to get Glaxo’s Pandemrix shot for herself and her daughters.

“The night before going I thought: Am I going to inject my children with this poison or in 20 years am I going to be in front of a judge with kids who are sick?” said Cartier, 35, who works in book production. “Five minutes before leaving, I wanted to turn around. I try not to think about it.”

In Ireland, more than 150,000 people in risk groups — pregnant women and people with underlying illnesses — had been vaccinated as of Nov. 25, Gerry Mulligan of the Health Service Executive said. The country has had lower-than-expected uptake among children under 5 since it began vaccinating them in mid- November, Mulligan said. Ireland started vaccinating schoolchildren on Nov. 30, he said.

In the German federal state of Thuringia, 150,000 of 2.3 million residents have been immunized since Nov. 9, according to Thuringia’s health department.

Bright Spot

Declining swine flu rates in some countries also may deter people from getting the vaccine. England reported the fourth consecutive weekly drop in new swine flu cases on Dec. 3. Visits to U.S. doctors for influenza-like illness fell to the lowest level in three months, the government said on Dec. 4.

One bright spot in Europe’s pandemic immunization effort is Scandinavia. A third of Sweden’s 9.2 million people are estimated to have gotten the swine flu shot as of Nov. 20, according to the Swedish Association of Local Authorities and Regions. About 3.3 million doses of vaccine had been delivered to Sweden as of Nov. 20 and demand has outpaced supply.

“Everybody in my family got the shot,” said Jenny Mattisson, 36, a mother of three who lives in a suburb of Stockholm and usually doesn’t get a seasonal flu shot. “Our daughter is in a risk group so we wanted to try to minimize the chance of her getting sick, but I would have taken it anyway. I think it’s a good idea to get the vaccine; it helps slow it from spreading.”

Norway, U.S. Demand

Norway, where mutations in the H1N1 virus have been detected among two patients who died of the flu and one who was severely ill, had vaccinated all 1.2 million people in its risk groups as of Nov. 24, almost 25 percent of its total population, said Bjoerne-Inge Larsen, director general of Norway’s Directorate of Health. Finland has immunized about 1 million people, or 19 percent of its population, the government said on Nov. 26.

In the U.S., demand for the vaccine has been strong, with quick uptake of doses as they become available and waiting times at many providers, said Joseph Quimby, a spokesman for the U.S. Centers for Disease Control and Prevention, in an interview on Dec. 4. Doctors had administered about 20 million shots by mid- November. Health officials plan to release updated estimates of inoculations in the next few weeks, Quimby said.

There were 73 million vaccine doses available for distribution by the end of last week and an additional 10 million doses arriving this week, CDC director Thomas Frieden said in a press conference Dec. 4. Some states are beginning to offer the shots to a wider audience, after initial supplies were focused on protecting pregnant women, children and adults with chronic health conditions.

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.