Tuesday, March 29, 2011

Breast cancer could be curbed by preventive drug treatment

I am always leery of new drug treatments but could this be something that could help high-risk patients that are not open to holistic treatments?
I hope that some day that things like this won’t be necessary, but for those who won’t change their lifestyles or aren’t open to natural methods, hopefully things like this will work without too many complications. Time will tell. 
Isn't it odd that even though they think it would help women, they are having problems getting it approved for what they want to use it for? Go Figure!
All the best
Lou & Debbie

Breast cancer could be curbed by preventive drug treatment
The Independent
By Jeremy Laurance, Health Editor
Monday, 28 March 2011

One in 10 women at the highest risk would benefit from the drug treatment.
The soaring rate of breast cancer in Britain could be curbed if drugs to prevent the disease were offered to women in the same way that statins to lower cholesterol are offered to people at risk of heart disease, a panel of experts has concluded.
One in 10 women in the highest risk band would benefit, they said. Trials of newer drugs currently under way could eventually see preventive treatment offered to as many as half of all post-menopausal women.
The 12 international experts met in Switzerland last year to review the latest evidence and have published their conclusions in a consensus statement in Lancet Oncology today.
They draw a parallel with statins for the prevention of heart disease, which have been in widespread use for more than a decade and are taken by millions. But the use of drugs to prevent cancer is in its infancy and is still unfamiliar.
"The idea of preventing cancer with drugs seems quite alien," said Professor Jack Cuzick, the chairman of the expert panel and Cancer Research UK epidemiologist at Queen Mary, University of London. "But if someone came to a clinic with high cholesterol and was told 'Come back in a year and we will check you again' you would think that was mad. Yet that is what we do with cancer."
The equivalent of cholesterol levels in cancer is the density of the breast tissue, as seen on a mammogram. Women with dense breasts have a four times greater chance of developing cancer than those with the least dense breasts.
One in 10 women has dense breasts, defined as those where more than 75 per cent of the mammogram shows up as opaque white fibrous tissue, and should be offered drug treatment, the experts say.
Breast density offers a simple measure of risk for women in the same way that blood cholesterol levels provide a measure of heart disease risk.
Once started on preventive drugs, a reduction in breast density can be used to measure their effectiveness in the same way as a fall in cholesterol indicates a response to statins.
Breast cancer is rising rapidly with almost 48,000 new cases a year, an 80 per cent increase in 30 years. The rise is being driven by lifestyle changes that alter the levels of female hormones including later childbirth, smaller families, shorter breast feeding, growing obesity, increased alcohol intake and lower exercise.
Until now, prevention efforts have focused on encouraging women to exercise more, eat less and cut down on alcohol. But unlike heart disease, preventive drug therapy has not been emphasized.
The main drug recommended is tamoxifen, which shows a 40 per cent reduction in risk when taken for five years but has side effects including blood clots and a small extra risk of endometrial (womb) cancer. But a trial of a newer class of drugs – aromatase inhibitors – is under way and may show an even bigger reduction in breast cancer risk.
"We are hopeful we will see on the order of a 70 per cent reduction. It is generally better tolerated. You don't get the blood clots or the endometrial cancer. But it does cause bone thinning in some women so that has to be monitored. It is only suitable for post-menopausal women but it might be suitable for half of them," Professor Cuzick said.
How easy is it to get the drugs?
Women hoping to obtain the drugs face a difficulty. The main drug recommended – tamoxifen – is only licensed in Europe as a treatment for breast cancer, not as a preventative. It is "off patent" and its original manufacturer has not applied to extend its licence to include prevention, which is holding back its use. It can only be prescribed "off label", where the doctor carries the risk.
Professor Jack Cuzick, chairman of the expert panel and Cancer Research UK epidemiologist at Queen Mary, University of London, said: "This is an enormous problem. Tamoxifen is not licensed for prevention, but all the experts believe it should be. Only the manufacturer can apply and, because it has gone off-patent, it does not want to bear the cost. There is no mechanism for getting it licensed. It is a crazy situation."
Tamoxifen has been shown in trials to reduce the risk of breast cancer by 40 per cent when taken for five years. But it has side effects, including an increased risk of blood clots, and a small increase in endometrial cancer of the womb. Raloxifene is also recommended – it has fewer side effects but less benefit. Tamoxifen was licensed for prevention in the US before the patent ran out.

Monday, March 28, 2011

FDA Reverses Stance on Fracture Warnings for OTC Heartburn Meds

Wednesday, March 23, 2011

Keep Questionable Synthetic Additives Out of Organics!

Take a moment and send a letter or email!  We need to make sure we stop things like this from happening.  
f not you, who? If not now - if we wait, it will be too late!

This is longer than I like to put on the blog but we believe it's important.
All the best,
Lou & Debbie
Keep Questionable Synthetic Additives Out of Organics!
Protect Babies' and Children's Health
March 21, 2011
In conventional foods, the government allows the use of toxic pesticides, genetically engineered crops, and novel synthetic additives that have not been tested for safety. As organic consumers, we say: “No thanks, we’d rather not be part of this huge uncontrolled experiment!” 
Organic foods offer an alternative, but some pro-corporate members of the National Organic Standards Board (NOSB), the panel set up by Congress to advise the Secretary of Agriculture on organic standards, would like to open the door to all synthetic additives to be added freely to organic foods—as long as they have, theoretically, nutritional value. 
Any “nutrient” synthetic additive that comes on the market would become fair game for organics, even those that have never before been part of the human food system, chemically extracted with toxic solvents, grown in genetically engineered feedstock, and otherwise produced in ways that would shock any organic consumer.
Synthetic “nutrient” additives often have no scientifically proven benefits, and act primarily as corporate agribusiness marketing gimmicks.
We must reject this outrageous proposal!  The USDA is encouraging citizens to send them your comments. The members of the NOSB and the National Organic Program need to hear the following message from organic consumers, farmers and businesses:
  • The NOSB Handling Committee’s proposal to allow any and all “nutrient” additives —without the required vetting as required by Congress—in organics is outrageous.
  • Essential nutrients that are required by the Food and Drug Administration should remain allowed in organics—but the organic standards should not be broadened to allow any synthetic, novel, untested “nutrient” additive created by agribusiness and biotechnology corporations.Please reinforce that all synthetic additives should continue to be individually reviewed and approved for use in organics.
  • Reports from parents and health care professionals suggest that some infants react with diarrhea, vomiting, and other gastrointestinal symptoms to two unreviewed synthetic additives already in organic infant formula. This should not be tolerated in organics!
The synthetic “nutrient additives” DHA and ARA, added to infant formula despite extremely weak scientific evidence of their benefits, and reportedly linked to serious gastrointestinal side efffects in some infants, provide a striking example of the importance of keeping the organic standards strong.
The committee proposal is couched in terms of consumer “maximum freedom of choice” and “harmonizing government agency rules.” Consumers who wish to consume synthetic nutrient additives that were not carefully regulated by the National Organic Program are always free to buy conventional foods. If this proposal is accepted by the full Board at the April meeting, there will be one clear winner: corporations whose synthetic, non-organic, novel and untested additives will be allowed freely in organic foods.
Take Action
To submit your comment electronically, follow the link: 
and submit comments before the April 10 deadline.
To submit your comment via mail:
Address your comment to:
Ms. Patricia Atkins,
National Organic Standards Board,
1400 Independence Ave., SW.,
Room 2646-So., Ag Stop 0268,
Washington, DC 20250-0268.
Identify the following docket number on your letter: AMS-NOP-11-0014.
Tell your family and friends to submit their comments as well!
To speak in person at the NOSB meeting:
In addition to sending their written comments, organic consumers living in the Seattle area, or willing to travel, are encouraged to also sign up for a five-minute speaking slot at the meeting at the end of April. Individuals can find more information about the meeting, and can pre-register for a slot by April 10, 2011, by visiting http://www.ams.usda.gov/nosbseattleslots or by calling (202) 720-3252.
Sample Letter
Please use the sample letter below, but remember that personalized, individual letters are much more effective and powerful than sample letters (please feel free to edit, add your own words, or construct your own message)!
Dear Members of the National Organic Standards Board,
Please reject the Handling Committee’s proposal to allow any and all “nutrient” additives in organics. This outrageous proposal, if accepted, would indiscriminately weaken the integrity of the organic label.
Currently, the organic standards allow the addition of synthetic vitamins and minerals in organic foods. Any other nutrient additives, however, must be individually petitioned, reviewed and approved. This rigorous system is what sets organic foods apart from conventional foods.
Please do not weaken the organic standards by opening the door to any nutrient additive—many of which are untested for safety, lack scientific evidence of benefits and have been produced in ways that do not conform to the organic standards (fermented in genetically engineered feedstock, extracted with the use of toxic solvents, etc.).
Want to Become an Expert? In-depth Background:
Under current federal organic standards, any manufacturer of a synthetic nutrient additive must petition the NOSB, have the additive reviewed by experts for safety and environmental sustainability concerns, give the opportunity for all members of the organic community to comment, and finally, gain approval from the Secretary of Agriculture before it can add the synthetic nutrient to organic foods.
This rigorous process protects consumers from novel, synthetic additives that could potentially be dangerous to human health or the environment. It is what sets organic foods apart—not just any additive developed in a laboratory and chemically produced in a factory can be added to organic foods without first being carefully reviewed by experts and accepted by the organic community.
Since federal regulations favor strong organic standards and work on behalf of organic consumers seeking safe and wholesome foods, it should come as no surprise that corporate agribusiness, and their friends on the National Organic Standards Board, seek to change this regulation—in favor of corporate profits.
Why the Battle over “Nutrient Additives”?
The battle over the role of “nutrient additives” in organics has come to the forefront after the Cornucopia Institute discovered, through Freedom of Information Act requests, that the previous administration at the National Organic Program (NOP) had inappropriately allowed the synthetic additives DHA and ARA in organic infant formula.
As reported in a Washington Post investigative report, the manager of the NOP under the Bush administration had brokered a back-room deal with a corporate lobbyist to misinterpret the federal organic standards in order to allow these profitable additives in organic foods.
In April 2010, the current manager of the National Organic Program at the USDA admitted publicly that this was an improper decision. The current NOP administration publicly shared its view that the decision to open the door to any additives allowed by the FDA was based on an “incorrect interpretation” of the organic standards, and encouraged the NOSB to clarify the situation. The Board should have reinforced that only vitamins and minerals required by the FDA should be allowed freely in organics—all others should be petitioned and carefully reviewed, as the law currently requires.
As a shock to the organic community, the corporate-affiliated members of the NOSB committee have proposed the exact opposite—to allow any synthetic additive, with alleged nutrient value, that comes on the conventional market to also be allowed in organic foods.
An example of “nutrient additives”—DHA and ARA
DHA and ARA are striking examples of why the committee’s proposal would indeterminably weaken the integrity of the organic label. Synthetic DHA and ARA would qualify as “nutrient additives.” They are produced by Martek Biosciences Corporation from fermented algae and fungus that have never before been part of the human diet. They have never been formally approved for use in organics, yet food manufacturers that believe they are above the law are already adding them anyway.
According to Martek, these organisms are cryogenically frozen, fermented in corn syrup (that is likely genetically engineered), chemically extracted with a toxic solvent, deodorized and bleached. The resulting oils, added to infant formula, contain nutrients that are structurally different from the nutrients found naturally in breast milk.
Numerous scientific review studies and meta-analysis studies conclude that there are no benefits to infant development from these additives—yet they are advertised as “supporting brain and eye development.”
Most disturbingly, reports from parents and health care professionals suggest that some infants react with diarrhea, vomiting, and serious gastrointestinal symptoms from these additives.
The NOSB Committee Proposal—A Sellout of Organic Values
The proposal by the NOSB’s Handling Committee will be voted on by the full Board at their April 26-29 meeting in Seattle, WA. The committee vote was split, 4-3, along pro-corporate profit/pro-consumer interest lines. With enough public outrage over this proposal, the full Board is likely to reject this outrageous proposal.
We urge the rejection of this proposal, not only to protect the future integrity of the organic label, but to ensure that synthetic additives like DHA and ARA, which have been linked to serious symptoms in some infants, are taken out of organics immediately.
The committee proposal is available on the NOP website. The proposal would change the organic standards to allow the following synthetics:
Nutrients, Vitamins and Minerals, Materials required or allowed by law for the purpose of enrichment, supplementation or fortification of foods, including infant formula, and materials the use of which is supported by the FDA or the Institute of Medicine of the National Academies.
There is currently no federal definition for “supplementation” of foods (a company looking to boost the protein level of an organic energy bar could therefore add chemically-extracted, conventional soy protein isolate, and argue it qualifies as a “nutrient additive”). There is currently no standard for what is “allowed by law.”
The proposal is poorly researched and poorly written—clearly with the intent of opening loopholes and allowing food manufacturers free rein to add any “nutrient” additive they’d like to organics.
Most importantly, the proposal’s authors clearly do not “get” organics. To say that any nutrient that is allowed by law or supported by the FDA should be allowed in organics is equivalent to stating that any pesticide that is allowed by law or supported by the EPA should be in organics.
It is a nonsensical statement—the whole point of organics is that the standards are stricter than those set for the conventional food supply. Organic consumers actually want strict standards, precisely because we are not interested in consuming anything that corporations develop to boost their own profits—especially when they are not tested for safety.
Say No to Synthetic Additives!
The strength of the organic label lies in the trust that consumers have in the strict standards and third-party certification system. Consumers like to know that their organic foods were grown without dangerous pesticides, genetically engineered crops, and other dangerous inputs, and that unapproved synthetic additives are kept out.
Organic consumers, farmers and business owners must send a strong message to the NOSB: the committee proposal on “nutrient additives” would allow untested, synthetic additives to organics—and we can not allow that to happen.
The Cornucopia Institute P.O. Box 126 Cornucopia, WI 54827www.cornucopia.org

What Causes Sleep Apnea?

Most of the time you read or hear about sleep apnea, you hear that you need a machine to help force air into your lungs while you sleep.  Why is it that we never hear a simple solution to a medical problem? Like most medical problems we encounter, if we exercised more and lost some weight we would all be better off. (and I do mean all of us ;-)
All the Best
Lou & Debbie

When you're awake, throat muscles help keep your airway stiff and open so air can flow into your lungs. When you sleep, these muscles are more relaxed. Normally, the relaxed throat muscles don't stop your airway from staying open to allow air into your lungs.
But if you have obstructive sleep apnea, your airways can be blocked or narrowed during sleep because:
  • Your throat muscles and tongue relax more than normal.
  • Your tongue and tonsils (tissue masses in the back of your mouth) are large compared to the opening into your windpipe.
  • You're overweight. The extra soft fat tissue can thicken the wall of the windpipe. This causes the inside opening to narrow and makes it harder to keep open.
  • The shape of your head and neck (bony structure) may cause a smaller airway size in the mouth and throat area.
  • The aging process limits the ability of brain signals to keep your throat muscles stiff during sleep. This makes it more likely that the airway will narrow or collapse.
Not enough air flows into your lungs when your airways are fully or partly blocked during sleep. This can cause loud snoring and a drop in your blood oxygen levels.
When the oxygen drops to dangerous levels, it triggers your brain to disturb your sleep. This helps tighten the upper airway muscles and open your windpipe. Normal breaths then start again, often with a loud snort or choking sound.
The frequent drops in oxygen levels and reduced sleep quality trigger the release of stress hormones. These compounds raise your heart rate and increase your risk for high blood pressure, heart attack, stroke, and irregular heartbeats. The hormones also raise the risk for or worsen heart failure.
Untreated sleep apnea also can lead to changes in how your body uses energy. These changes increase your risk for obesity and diabetes.

Thursday, March 17, 2011

First U. S. Clinical Trial To Treat Prostate Cancer With Diet Begins

Its great to see that someone is finally looking at something natural to treat disease.  When universities are starting investigating how a healthy diet can heal naturally, I can hardly believe it.  How did this one get past the FDA and big pharma?
All the best,

Lou & Debbie
First U. S. Clinical Trial To Treat Prostate Cancer With Diet Begins
Some of the very healthy foods -- such as cauliflower, brussels sprouts and broccoli -- that many boys desperately sought to shun from their diets in childhood just may be the key to staving off prostate cancer in adulthood. That hypothesis is the impetus of a new clinical trial underway at University of California (UC) San Diego Moores Cancer Center.
The study will evaluate the effect that comes from a change in diet, supported with telephone counseling and exercise, in stopping or delaying the start or progression of prostate cancer. It is the first clinical trial in the U.S. that is a non-supplement study on prostate cancer/diet.
"Ours is the first study to focus on changing the entire lifestyle rather than just giving the participants a supplement pill," said J. Kellogg Parsons, MD, MHS, urologic oncologist at UC San Diego Moores Cancer Center. "We focus on more vegetables, less meat, and comprehensive counseling which encourages a more active lifestyle."
Participants in the Men's Eating and Living (MEAL) Study will be eating at least seven servings of colorful, robust-flavored produce per day, particularly cruciferous vegetables and tomato products, fruit, as well as whole grains, beans or other legumes.
"Evidence in previous studies suggests that a diet high in vegetable intake and low in meat and fat intake may decrease the risk of prostate cancer progressing or even beginning," said Parsons.
Although approximately 100,000 men are diagnosed annually with early stage, low-risk prostate cancer in the United States, low-risk prostate cancer is a slow-growing disease and many of those afflicted may not require immediate treatment. Unnecessary aggressive surgical or radiation treatment diminishes quality of life for thousands of men each year, but the UC San Diego study researchers see an opportunity to hone, and even re-define, treatment options and patient susceptibility within this particular patient demographic.
"Diet provides the participant/patient with a way to take control and fight what can be a distressing diagnosis," explained Parsons. "If diet is related to the risk of prostate cancer, it may well exert an impact on the earliest phases of the disease. One of the implicit messages that participants will take from this study is that low-risk prostate cancer can often be a condition to monitor: it is not a death sentence, nor is it a condition that necessarily requires radical, immediate, life-changing intervention."
Eligible participants are males up to 80 years of age who have been diagnosed with non-aggressive   within the last two years, are in the early stages, and have not yet received treatment of any kind.

Wednesday, March 16, 2011

Would you go thru a naked body scanner?

Are you planning on flying in the near future?  

I had to go to Dallas not long ago but did not have to deal with this issue.
I know that I don't even like getting x-ray's, so why would I submit myself to something like this?
Whenever something like this makes the news, it makes me wonder -why do we allow them do this to us?
Do you feel any safer now that they are installing these? 
I know I don't!

Let us know you thoughts.

All the best

Lou & Debbie 

TSA Admits Bungling of Airport Body-Scanner Radiation Tests

The Transportation Security Administration is re-analyzing the radiation levels of X-ray body scanners installed in airports nationwide, after testing produced dramatically higher-than-expected results.
The TSA, which has deployed at least 500 body scanners to at least 78 airports, said Tuesday the machines meet all safety standards and would remain in operation despite a “calculation error” in safety studies. The flawed results showed radiation levels 10 times higher than expected.
At least one flier group, the Association for Airline Passenger Rights, is urging the government to stop using the $180,000 machines that produce a virtual-nude image of the body until new tests are concluded in May.
“Airline passengers have enough concerns about flying — including numerous ones about how TSA conducts its haphazard security screenings — so it is TSA’s responsibility to ensure passengers are not being exposed to unhealthy amounts of radiation,” Brandon Macsata, executive director of the group, said in a statement.
The Electronic Privacy Information Center has been a loud voice opposing the machines. Last week, it urged a federal appeals court to stop using them until further health studies were conducted. Marc Rotenberg, EPIC’s executive director, is expected to tell the same thing to a congressional panel Wednesday.
“The agency should have conducted a public rule-making so that these risks could have been more carefully assessed,” (.pdf) according to a transcript of his expected testimony before the House Committee on Oversight and Government Reform.
Still, the government said the results proved the safety of the devices.
“It would appear that the emissions are 10 times higher. We understand it as a calculation error,” TSA spokesman Sarah Horowitz said in a telephone interview.
The snafu involves tests conducted on the roughly 250 backscatter X-ray machines produced by Rapiscan of Los Angeles, which has a contract to deliver another 250 machines at a cost of about $180,000 each. About 250 millimeter-wave technology machines produced by L-3 Communications of New York were not part of the bungled results.
Rapiscan technicians in the field are required to test radiation levels 10 times in a row, and divide by 10 to produce an average radiation measurement. Often, the testers failed to divide results by 10, Horowitz said.
“Certainly, the errors are not acceptable. It’s not every report. We believe the technology is safe,” she said.  ”We’ve done extensive, independent testing. It doesn’t raise alarms in terms of safety.”
Rapiscan, in a letter to the TSA, admitted the mistake and is “redesigning the form” used by its “field service engineers” when surveying the Rapiscan Secure 1000 that is deployed to 38 airports.
“Oftentimes, the FSE will bypass the step of dividing by 10. While the resulting entry, at a pragmatic level, is understandable on its face and usable for monitoring purposes, the value, if read literally by persons unfamiliar with our system and the survey process, would imply energy outputs that are unachievable by the Secure 1000 Single Pose,” (.pdf) Rapiscan wrote.
A recent Wired.com three-part series examined the constitutionality,effectiveness and health concerns of the scanners, which the TSA mandated as the preferred airport screening method in February 2009. Among other things, the Wired.com series concluded that there was discord among the scientific community about the scanners’ health risks to humans, and that they were not tested with mice or other biological samples before being deployed.
The government, however, maintains a thousand screenings equal the amount of radiation of one standard medical chest X-ray.
A federal appeals court hearing EPIC’s lawsuit suggested last week it wasnot likely to halt the scanners’ use.

Thursday, March 10, 2011

Things You Didn’t Know about Water


Sometimes we don't do the things we know we should, like just drink good water...

All the best,
Lou & Debbie

Things You Didn’t Know about Water

Seventy-five percent of Americans are chronically dehydrated

In 37% of Americans, the thirst mechanism is so weak that it is often mistaken for hunger.

Even MILD dehydration will slow down one’s metabolism as much as 3%.

One glass of water will shut down midnight hunger pangs for almost 100% of the dieters studied in a University of Washington study.

Lack of water is the number 1 trigger of daytime fatigue.

Preliminary research indicates that 8-10 glasses of water a day could significantly ease back and joint pain for up to 80% of sufferers.

A mere 2% drop in body water can trigger fuzzy short-term memory, trouble with basic math, and difficulty focusing on the computer screen or on a printed page.

Drinking 5 glasses of water daily decreases the risk of colon cancer by 45%, plus it can slash the risk of breast cancer by 79%, and one is 50%less likely to develop bladder cancer.

Now - go get a good water system and drink some water...

Wednesday, March 9, 2011

Restrictions apt to cut Avandia sales

Never ceases to amaze me that drugs that are so dangerous are allowed to even get on the market...
All the best
Lou & Debbie

The diabetes drug is now meant only for those who have no other alternative. 

Associated Press / February 8, 2011
WASHINGTON — GlaxoSmithKline PLC has updated labels for its diabetes pill Avandia to include safety restrictions because of the drug’s links to heart attacks.
The Food and Drug Administration ordered the changes in September, the last in a series of actions against the former blockbuster drug. Avandia has triggered thousands of lawsuits and a Department of Justice investigation. The European Union has banned the drug.
The new US label indicates Avandia is intended only for patients who cannot control their blood sugar with any of other medications. Patients who are currently on the drug can continue taking it after consulting with a doctor.
The FDA approved Avandia in 1999 and it became the top-selling diabetes pill in the world, with more than $3 billion in sales by 2006. But its use has plummeted since a 2007 analysis linked the drug to heart attacks.
More than 900,000 US patients filled prescriptions for Avandia in the first half of 2010, according to the health data firm IMS Health. That number is expected to shrink as the new FDA restrictions kick in.
London-based Glaxo reported last year that the Justice Department and several state attorneys general are investigating Avandia. A Senate investigation released last year concluded Glaxo knew about the drug’s risks years before they were made public and withheld data from the FDA.
The company has reportedly settled thousands of personal injury lawsuits.

Tuesday, March 8, 2011

Japan Stops Use of Pfizer, Sanofi Vaccines on Four Deaths

I just read that the Vaccines makers just won another round of court battles that keeps them from being sued for damage from their drugs?  Now we read this.  When will the FDA investigate this themselves?
All the best
Lou & Debbie
Feel free to share this with your friends...
Japan Stops Use of Pfizer, Sanofi Vaccines on Four Deaths
By Jason Clenfield and Junko Hayashi - Mar 6, 2011 9:49 PM ET
Japan’s health ministry suspended the use of pediatric vaccines made by Pfizer Inc. (PFE) and Sanofi- Aventis SA after reports of four deaths following immunizations.
The use of Pfizer’s Prevenar, to protect children against meningitis and pneumonia, and Sanofi’s ActHIB, to fightHaemophilus influenzae type b, will be suspended until at least tomorrow, when a safety panel will meet to discuss the cause of the deaths, the ministry said in a March 4 website posting.
The temporary suspension is a precautionary measure following the deaths of four children who had previously been immunized simultaneously with several pediatric vaccines, said Victor Carey, the Sydney-based Asia Pacific medical director for Sanofi’s vaccines unit. About 1.5 million Japanese children have received ActHIB since it was approved in Japan in 2007, 15 years after it was first licensed in Europe, he said.
“No causal relationship has been established between immunization and these fatalities, but an investigation is under way, which we’re fully cooperating with,” Carey said in a telephone interview.
Haemophilus influenzae type b, or Hib, caused 2 million to 3 million cases of serious disease, notably pneumonia and meningitis, and 386,000 deaths in young children in 2000, according to the Geneva-basedWorld Health Organization.
More than 200 million doses of ActHIB have been given to children in more than 120 countries, according to Paris-based Sanofi.
Multiple Vaccines
The deaths of the children in Japan occurred from March 2 to March 4, the ministry said. ActHIB was given to three of the four children, who were simultaneously vaccinated with at least one other vaccine from a different manufacturer, Carey said.
Pfizer’s Prevenar is a so-called pneumococcal conjugate vaccine that aims to prevent invasive disease caused by serotypes of the Streptococcus pneumoniae bacterium. The vaccine that protects against 13 serotypes generated $2.42 billion last year and a shot that fights seven serotypes had $1.25 billion in 2010 sales, according to data compiled by Bloomberg.
Surveillance in North America and Europe, where Prevenar has been used for at least a decade, hasn’t identified any major safety concerns, the WHO said in a 2007 report. Evidence suggests pneumococcal conjugate vaccines will have a “considerable impact on pneumococcal disease and overall infant mortality,” the United Nations health agency said.
Victoria Davis, a Pfizer spokeswoman, declined to comment specifically on the deaths in Japan.
“Pfizer thoroughly reviews and continually monitors all of its medicines and vaccines as safety is our top priority,” the New York-based drugmaker said in an e-mailed statement. “The company thoroughly evaluates all reported cases and works closely with health authorities to determine if there is any association with use of our medicines and vaccines.”
To contact the reporters on this story: Jason Clenfield in Tokyo at jclenfield@bloomberg.net; Junko Hayashi inTokyo at juhayashi@bloomberg.net
To contact the editor responsible for this story: Jason Gale in Singapore at j.gale@bloomberg.net.