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by David Perlmutter, MD, FACN, ABIHM
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AP Poll: Third of parents oppose swine flu vaccine

October 10th, 2009

From WashingtonPost.com:

As the first wave of swine flu vaccine crosses the country, more than a third of parents don’t want their kids vaccinated, according to an Associated Press-GfK poll.

Some parents say they are concerned about side effects from the new vaccine – even though nothing serious has turned up in tests so far – while others say swine flu doesn’t amount to any greater health threat than seasonal flu.

Jackie Shea of Newtown, Conn., the mother of a 5-year-old boy named Emmett, says the vaccine is too new and too untested.

“I will not be first in line in October to get him vaccinated,” she said in an interview last month. “We’re talking about putting an unknown into him. I can’t do that.”

The AP poll found that 38 percent of parents said they were unlikely to give permission for their kids to be vaccinated at school.

The belief that the new vaccine could be risky is one federal health officials have been fighting from the start, and they plan an unprecedented system of monitoring for side effects.

They note that swine flu vaccine is made the same way as seasonal flu vaccines that have been used for years. And no scary side effects have turned up in tests on volunteers, including children.

On Wednesday, Health and Human Services Secretary Kathleen Sebelius appealed for widespread inoculation against swine flu, vouching unconditionally for the vaccine: “We know it’s safe and secure.”

The AP poll, conducted Oct. 1-5, found 72 percent of those surveyed are worried about side effects, although more than half say that wouldn’t stop them from getting the vaccine to protect their kids from the new flu.

Giving flu shots to schoolchildren is also an idea many parents are still getting used to. It was only last year that the government recommendation kicked in for virtually all children to get it. Seasonal flu vaccination rates for children last year ranged from about 48 percent for toddlers to about 9 percent for teens.

It traditionally takes a while for parents to learn about and accept a new vaccine and years for immunization rates to grow, said Dr. Matthew Davis, a University of Michigan Medical School associate professor who has overseen polling on flu issues.

Special swine flu vaccination clinics at schools are being planned in many states. Children are the main spreaders of infectious disease, and if large numbers are coming down with swine flu, there are ripple effects for everyone else.

In public health bill, a contagion of fear

September 20th, 2009

From Boston.com:

The banner, bold and provocative, was tattooed with a syringe, skull and crossbones, and a call to action: “Say no to forced vaccination.’’

The message, delivered last week on Beacon Hill, was aimed at a seemingly prosaic piece of legislation that aims to better define – and, in some respects, restrict – the emergency powers of the state’s public health officials.

Within the bill’s arcane language, a 16-month-old activist coalition sees government authority run amok: mandated vaccinations, quarantines, arrests, fines. Swine flu, they warn, will be the virus that opens the door to the public health police.

“We have a concern that we will be forced to be quarantined if we refuse the vaccine,’’ said Laura Jackson, president of the Liberty Preservation Association of Massachusetts, which mustered 30 to 40 members for the lobbying drive. “What I’d like to see done with this law is have it burned.’’

Those concerns, public health authorities insist, are entirely unfounded. But the association’s multimedia campaign – aired over talk radio and its website – compelled state Public Health Commissioner John Auerbach to send an italicized, bold-faced missive to legislators, stressing that “mandatory vaccination is not and has never been part of the plan or discussion in Massachusetts’ pandemic response.’’

The bill, Auerbach and other top officials said in interviews, would never force anyone to be vaccinated unwillingly, and its extraordinary measures – such as quarantining people who decline inoculations – would be reserved for equally extraordinary times, such as a bioterror attack or the emergence of a highly lethal, rapidly spreading germ. Swine flu, caused by the H1N1 virus, is not such a germ, Auerbach said.

The protest by the group, whose founders supported Republican Ron Paul in the 2008 presidential election, reached its pitch at an especially delicate moment for public health authorities. Auerbach’s letter demonstrates that his agency is worried the dissent could raise doubts about vaccination and imperil an unprecedented campaign to inoculate millions this fall against the seasonal flu and the swine strain.

“Accuracy of information is going to be key in terms of the public understanding what they should do,’’ Auerbach said in an interview.

In the opposition to Massachusetts’ revised public health emergency law, as well as in the combustible health care town hall meetings that greeted some members of Congress this summer, analysts see more than traditional conservative concerns about individual liberty and big government.

They also find signs of deeper worries about a world descending into uncertainty, with panic over economics and the emergence of a novel flu strain.

“It doesn’t surprise me that when you have another epidemic, another threat of a disease, then you get emotions tweaked up, and separately in the health care debate, we’ve seen a rise in emotionalism replacing logic,’’ said Gene W. Matthews, a senior fellow at the University of North Carolina’s Institute for Public Health.

Matthews was among those who presided over efforts to update public health emergency regulations when he was the top attorney at the US Centers for Disease Control and Prevention.

The terrorist attacks of Sept. 11, 2001, and the arrival of anthrax-laced letters at congressional and media offices a month later revealed a largely ignored truth about those laws: In many states, they had not been updated for decades.

A team led by Lawrence O. Gostin, a Georgetown University law professor, drafted the language that has served as a model for Massachusetts’ proposed law and for revised rules adopted in 37 states so far.

“Most of the laws were very antiquated,’’ Matthews said, “and they didn’t recognize concepts of due process and individual rights and legal evolution that had occurred in the last 50 years.’’

In times of emergency, medical authorities had long possessed sweeping powers to do what was necessary to protect the public’s well-being. According to the state Department of Public Health, such emergencies have been declared only three times since the 1970s, with the most recent being a 2006 order for aerial spraying to combat Eastern equine encephalitis in Southeast Massachusetts. In 1993, when West Stockbridge’s water supply ran dry, the agency used its powers to tap water from a private source. And in the 1970s, the state took control of a financially teetering nursing home.

The updated legislation, passed by the Senate in late April and awaiting action in the House, carries penalties for certain violations: People who refuse orders to remain isolated could face up to a month in jail and fines as high as $1,000 a day.

But the proposed law also would, in certain instances, provide a check on the power of health officials. For example, a judge’s approval would now be needed before a government agency could perform tests or a physical examination on someone thought to present a significant medical risk to the community.

Bob Dwyer, an opponent of the law, said the Liberty Preservation Association was “not trying to say don’t take the vaccines’’ against the flu.

Still, he said, he believes the emergency law “violates numerous rights that we have in the Bill of Rights and the Constitution,’’ including the right to freely assemble. The law is unnecessary, he insisted, because most people don’t need the threat of legal action to persuade them to remain home when they’re sick.

It’s understandable that some people might greet talk of quarantines with trepidation, said Valerie Bassett, executive director of the Massachusetts Public Health Association.

But such measures, taken in rare circumstances, are “the same reason you drive within the lane on the highway,’’ Bassett said. “It’s about the protection of health and life.’’

Health Workers Are Reluctant to Get Swine Flu Vaccine

August 27th, 2009

Dr. Perlmutter’s comment: What do you suppose healthcare workers know that the general population doesn’t ?

From Bloomberg.com:

Less than half of health-care workers in Hong Kong are willing to be vaccinated for swine flu, mainly because of worry over side effects, research published today in the British Medical Journal shows.

The proportion of medical workers including nurses and doctors who plan to be immunized against H1N1, the virus that causes swine flu, was 47.9 percent when polled in May, when the World Health Organization’s pandemic alert was at the second- highest level of 5, researchers at the Chinese University of Hong Kong said. The WHO raised the alert to level 6 in June.

“The prevailing sentiment is that people don’t want to get it,” Thomas Tsang, acting controller of Hong Kong’s Centre for Health Protection, said on Aug. 23 at a meeting on influenza organized by The Lancet medical journal, China’s health ministry and the WHO. “They are afraid of all sorts of side effects.”

Health-care workers will be among the first inoculated against swine flu in most countries that have announced immunization programs when vaccine producers begin delivery during autumn in the Northern Hemisphere. The WHO’s Strategic Advisory Group of Experts on Immunization recommended last month that countries vaccinate medical personnel first to keep health- care systems operating before determining other priority groups.

H5N1 Study

A separate survey done by the same researchers found that 28.4 percent of respondents said they were willing to be vaccinated for the H5N1 bird flu strain when asked in January to March, when the pandemic alert was at level 3. There were “no significant changes” in the level of willingness to get inoculated against H5N1, which kills three of every five reported cases, after the WHO raised the alert to level 5.

The researchers looked at self-administered, anonymous questionnaires from 2,255 health-care workers at 31 Hong Kong public hospital departments for the two studies.

The surveys show a “consistently low level of willingness” to accept pre-pandemic flu vaccination, the study said. The researchers were surprised that more respondents — three-quarters of whom were nurses — didn’t plan to be vaccinated, given the impact of the 2003 SARS outbreak on Hong Kong. Those who weren’t planning to get the shot expressed doubts about its effectiveness among reasons for declining it.

“Vaccination is one of the potentially effective measures that can reduce mortality and morbidity from pandemic influenza,” the authors wrote. “However, the effectiveness of this measure depends heavily on the uptake rate in those groups assigned high priority.”

Infection Rate

H1N1 has infected at least 182,166 people and killed at least 1,799 around the world as of Aug. 13, the WHO said last week. The figures are based on laboratory-confirmed cases reported to the Geneva-based UN agency.

The WHO’s pandemic alert level of 5 signifies human-to- human transmission in at least two countries in one region. The highest phase, 6, indicates sustained community-level outbreaks in at least one country in another WHO region.

Most studies show that less than 60 percent of health-care workers have seasonal flu shots, according to the BMJ report.

An online survey of almost 1,500 readers of Nursing Times, a U.K. trade publication, published last week found that 30 percent didn’t plan to get vaccinated against swine flu and 37 percent did. The remainder was undecided. Liam Donaldson, England’s chief medical officer, said last week that the U.K. wouldn’t require health-care personnel to get inoculated

Parents Doubt Gardasil’s Safety

August 21st, 2009

From ABCNews.go.com :

“I thought I was protecting my daughter.”

Tammy Harper, 42, now fears that vaccinating her 14-year old daughter against several strains of the human papilloma virus, or HPV, may not have been the right thing to do.

Harper, from Merrit Island, Fla., is one of many parents gripped by doubt about the safety of Gardasil, the 3-dose vaccine that promises to protect against cancer-causing HPV infections, following media reports this week on government data that called the vaccine’s safety into question.

Despite her initial reservations about Gardasil being a relatively new drug without data on long term side effects, Harper said her daughter’s pediatrician strongly recommended the vaccine. In addition, she feared cancer, having seen a family friend succumb to ovarian cancer.

“I wanted to know … is it going to keep the cancer [away],” Harper said. “I’m concerned now that I’ve given her a vaccine that’s supposed to protect her. Now who knows what I’ve condemned her to?”

The government report released Tuesday linked Gardasil to 32 unconfirmed deaths as well as incidents of blood clots and neurological disorders. More common, non-life threatening side effects of the vaccine included fainting, nausea and headaches. All adverse effects occurred in a pool of over 25 million doses of Gardasil administered in the U.S.

Official Recommendations Have Not Changed
To date, none of the official recommendations regarding Gardasil use, which is indicated for girls and women between ages 9-26, have changed.

“We recommend the completion of the series of three doses of HPV vaccine within the recommended window for optimal effectiveness,” said Arleen Porcell-Pharr, a spokesperson for the Centers for Disease Control and Prevention. “We don’t have enough data to analyze how effective the vaccine is with only two doses. In the event the person can’t follow the recommended schedule, we still want the person to complete the series, no matter how long it takes.”

Parents whose daughters have received one or two doses of Gardasil may fear that they have ventured down a one-way path where they have no choice but to await a bad reaction to the vaccine.

No Adverse Reactions Now Probably Means No Adverse Reactions Later
But experts are quick to point out that if a patient has not exhibited adverse reactions after receiving one or more vaccine injection, they are unlikely to do so. Stopping the course of treatment has no evident medical drawback beyond failure to protect against HPV.

“We continue to counsel anyone who has already started the vaccine to continue the vaccine, especially if they’ve had no adverse reactions,” said Dr. Eugene Shapiro, associate chair of the Department of Pediatrics at Yale University School of Medicine.

In fact, Dr. Richard M. Haupt, head of the clinical program for Gardasil at Merck, the vaccine’s manufacturer, said the small number of adverse events reported supported the vaccine’s safety. As to whether or not to continue or discontinue the vaccination course, Haupt said that decision was for a family to make.

“Obviously that decision and discussion is important to occur between a family and their healthcare provider,” he said. “But for maximal benefit, all three doses should be given.”

Risk Tolerance Figures in Deciding Whether to Get the Vaccine
Other doctors say that deciding to get or continue getting the Gardasil vaccine depends largely on a family’s tolerance for risk.

“If they’ve only had one dose and they’ve had no problems with it, it could make sense to pull out and not do any more doses,” said Dr. Diane Harper, director of the Gynecologic Cancer Prevention Research Group at University of Missouri. “If they’ve had two doses, they’ve already swallowed the fish hook. If nothing bad happened, after the third dose the chances of an [adverse event] are really, really small.”

Harper added that parents, particularly those whose daughters are 11-12 years old, may want to carefully consider whether to continue administering Gardasil compared to girls who are receiving the vaccine in their late teens or early 20s, when the vaccine has a greater beneficial impact.

But others argue that vaccinating early provides protection before exposure to HPV and would not counsel the parents of a pre-teen differently than the parents of an older girl.

Vaccinating Young Is Easiest
“At that [11-12] age group, they are getting lots of other shots, they’re in the pediatrician’s office,” said Dr. Kevin Ault, associate professor of Gynecology and Obstetrics at Emory University. “If anything we want to aim younger rather than older.”

The uncertainty of future consequences of the vaccine may be most troubling to parents who wish to protect their daughters from HPV and potential cervical cancer.

“I’m worried about the long-term effects of a vaccination [for which] they don’t know the results,” said Mimi Denhart, 45, whose 12-year-old daughter received her first dose of Gardasil last week.

Shapiro said that the long-term effects are not known and cannot be known until after future analysis but that any potential risk is a well calculated one.

“That effectiveness is going to be long term … takes a certain leap of faith but it has been true of most vaccines,” he said. “We can change and adapt as we get more information, but the best information [available] now is that the benefits exceed the risks.”

Swine flu vaccine linked to deadly breathing disease

August 17th, 2009

From dailymail.co.uk:

Doctors have been put on alert for a deadly disease linked to swine flu jabs.

The Health Protection Agency has told neurologists to look out for a rise in Guillain-Barr Syndrome – in which paralysis of the breathing muscles can cause death by suffocation – when vaccination starts in the next few weeks.
The link was made following a mass immunisation programme in the U.S., in which a swine flu jab was blamed for more deaths than the disease itself.
More than 40million Americans were vaccinated after an outbreak of swine flu at an army base in 1976.
The programme was abandoned after hundreds of cases of GBS were diagnosed and 25 died.
The flu, however, did not spread further than the base and claimed only one life.

In a letter to the Association of British Neurologists, Elizabeth Miller, head of immunisation at the HPA, said: ‘GBS has been identified as a condition needing enhanced surveillance when the swine flu vaccines are rolled out.’
The warning will add to concerns about the safety of the jab, which will be given to more than 13million Britons from October.
Professor Patrick Chinnery, of the Association of British Neurologists, said: ‘This is a belt-and-braces approach to safety and is not something people should be worried about as it’s a rare condition.’