FDA: Don't Eat Maine Lobster Tomalley

Chantix Investigation: From FDA Approval To Market

How "Independent" Are Vaccine Defenders?

Sharyl Attkisson Investigates Vaccine Advocates Taking Funding From The Companies Whose Vaccines They Endorse

WASHINGTON, July 25, 2008(CBS) For years some parents and scientists have raised concerns about vaccine safety, including a possible link to autism and ADD. Many independent experts have sided with government officials and other scientists who say there's no possible connection. But how "independent" are they? CBS News investigative correspondent Sharyl Attkisson shares here's what she found.

New U.S. group defends ethanol in food vs fuel fight

By Lisa Shumaker

CHICAGO (Reuters) - A new group is adding its voice to the debate on using crops to produce alternative fuels such as ethanol amid rising food prices and shortages in some countries.

The Alliance for Abundant Food and Energy in Washington D.C. was created by Archer Daniels Midland Co, DuPont Co, Deere & Co, Monsanto Co and the Renewable Fuels Association (www.foodandenergy.org).

"There are critics who are trying to create an either-or decision between food and fuel," said Mark Kornblau, the alliance's executive director. "We believe this is a false choice. Today, more than 90 percent of crops in the United States and around the world are used exclusively for food."

The group believes that agricultural innovation -- such as genetically modified crops -- is the best way to address global hunger, not reducing biofuel production.

Decatur, Illinois-based ADM is one of the world's largest producers of biofuels, and Monsanto is a leading producer of GMO seeds.

Kornblau did not say exactly how much money the founding members contributed but said "the initial budget is in the multimillions."

The food versus fuel debate heated up as U.S. food prices last year saw their biggest increase in 15 years and are forecast to rise by 5 percent this year.

World food prices rose by 40 percent last year, causing food riots, hoarding and bread lines in some countries.

At the heart of the debate is to what degree the popularity of biofuels has contributed to the rapid rise in food prices.

Corn, soybean and wheat prices at the Chicago Board of Trade hit record highs this year amid increased global demand for food, rising oil prices and government mandates for biofuels.

About 34 percent of the U.S. corn crop this year will be used to make ethanol, compared with 23 percent last year, according to the U.S. Agriculture Department.

"Most credible studies say the rising price of food right now can be attributed to the high price of oil," Kornblau said. "To get your Idaho potatoes to Massachusetts or Florida, you have to have them shipped."

Crude oil prices have soared by 70 percent in the past 12 months and hit a record high of $147.27 a barrel on July 11. U.S. oil futures closed at $125.49 a barrel, up $1.05, on Thursday.

The new alliance faces tough opposition. Both livestock and food producers have lobbied to reduce or eliminate subsidies for ethanol. Their efforts may have succeeded to some degree.

The new U.S. farm law cuts the tax credit for corn-based ethanol by 6 cents to 45 cents a gallon beginning in 2009. The law extends the 54-cent import tariff on ethanol through 2010.

Tyson Foods Inc has backed eliminating U.S. ethanol subsidies and has seen its profits hurt by higher feed costs for its poultry, pork and beef processing business.

The Grocery Manufacturers' Association has criticized ethanol for driving up food prices.

(Reporting by Lisa Shumaker, editing by Matthew Lewis)

In Surprise Move, EPA Bans Carbofuran Residue on Food

The Environmental Protection Agency announced yesterday that it will no longer allow residue of the toxic pesticide carbofuran on domestic or imported food, a decision that would effectively remove the chemical from the U.S. market.

EPA officials said they made the decision -- which surprised environmentalists as well as the pesticide's sole U.S. manufacturer -- on the grounds that the chemical residue poses an unacceptable safety risk to toddlers.

"This is a product that we don't believe meets our high standards for the general population, particularly for small children who are more sensitive," said James Gulliford, EPA associate administrator for the office of prevention, pesticides and toxic substances. "While there is little exposure today [to the pesticide], we don't think there's a need, a reason for any exposure."

A million pounds of carbofuran are applied each year in the United States, affecting less than 1 percent of the nation's farmed acres, according to the EPA, but it is used more heavily in developing countries on crops including rice, bananas, coffee and sugar cane. The EPA had indicated earlier this year that it would not apply the ban to imported food, but yesterday it said it will.

"This could have major ramifications around the world, as there are many countries that export rice, coffee and bananas to the U.S.," said Michael Fry, director of conservation advocacy for the American Bird Conservancy. "It's one of the most widely used pesticides in the world."

The Conservancy and the Natural Resources Defense Council, another environmental group, had petitioned the agency to ban carbofuran residue on food on the grounds that the neurotoxin threatens animals as well as humans. Over the past four decades, the chemical has killed millions of wild birds, including golden and bald eagles, red-tailed hawks and migratory songbirds, the groups said.

The EPA indicated two years ago that it intended to cancel carbofuran's registration, a different regulatory path that determines whether a product can be sold in the United States, because of the hazards it poses to workers who apply it as well as to birds and other wildlife.

But manufacturer FMC has been fighting the move in federal court, arguing that the agency must prove that the chemical represents a public danger. FMC is the first pesticide manufacturer in 20 years to resist cancellation of a registered pesticide.

Yesterday's decision -- which is subject to a 60-day comment period -- could take carbofuran off the market sooner than the registration cancellation process, which remains in progress, but FMC spokesman James Fitzwater said his company will push to keep selling the product.

"It does give us an opportunity to prove this product is safe from a dietary risk standpoint," Fitzwater said in an interview. "We think we have a good case."

The EPA's scientific assessment found that the neurotoxin exceeded the agency's safety standard for children ages 1 to 2 by 200 percent, said Steven Bradbury, director of the EPA's special review and re-registration division.

Bradbury said that the pesticide residues are in such small concentrations that they would rarely pose a risk, but that they could if certain foods were eaten in combination.

"If these exposures happen, they don't meet our rigorous standards," he said.

In proposing the ban, the EPA also overruled the Agriculture Department, which argued in written comments that federal officials should consider the benefits associated with keeping the pesticide on the market. Gulliford, however, said the EPA does not weigh such factors when judging the risk posed by food products.

"It's not a benefit-risks decision, it's a risk-based decision," he said in an interview, adding that the agency hoped to have the pesticide off the market before next year's growing season. "This is part of our process to ensure we have the safest food supply of any country in the world."

There is no question that carbofuran exacts a toll on wildlife: A 2006 EPA document examining the pesticide's environmental effects found that if a flock of mallard ducks wandered into an alfalfa field within a week after the chemical was applied, 84 percent of the birds would die. The pesticide also kills bees, which have experienced an unexplained massive population collapse in recent years.

"I was surprised and pleased that EPA did the right thing and followed the science," said Jennifer Sass, a senior scientist at the Natural Resources Defense Council. "This is really a big one for workers, birds and bees."

Search for HIV Vaccine Needs
Overhaul, Scientists Suggest

WASHINGTON -- Scientists will have to take "enormous intellectual leaps" to develop an AIDS vaccine in the coming years, say researchers clearly frustrated by the failure of a once-promising shot.

The researchers, including a top National Institutes of Health official, want new people with new ideas to step up and join the search. They say the focus of their research should be on discovering a vaccine rather than on clinical trials for evaluating medicines that may or may not work.

"Design of a vaccine that blocks HIV infection will require enormous intellectual leaps beyond present day knowledge," concluded a broad team of researchers writing in Friday's edition of the journal Science.

More than 6,500 new HIV infections occur daily world-wide. A recent high-profile trial of a potential vaccine not only failed to prevent infection, but those who got the inoculation appeared at increased risk of infection compared with those who were given a placebo.

After the disappointing results, the National Institute of Allergy and Infectious Diseases held a summit in March on how to reinvigorate vaccine research.

The institute will still support studies in people -- but it is raising the bar that candidate vaccines need to pass to get federal support. NIH is looking for fresh ideas on how to approach HIV vaccine discovery, and emphasizing basic laboratory research to fill in key gaps in knowledge. Among the priorities will be increased research in chimpanzees, the Science article says.

The recent failed vaccine study showed "we were maybe on the wrong track a bit," Anthony Fauci, the institute's director, told a Science podcast. "We will be turning the knob, as I like to say, more preferentially toward answering some of the fundamental questions that have gone unanswered," he said.

When contractors don't meet milestones, or when initiatives don't attract the highest quality of applications, money will be redirected to more promising research activities, Dr. Fauci's team wrote. Unfortunately, the need for more resources aimed at discovering a vaccine comes at a time when the National Institutes of Health's budget remains flat, the officials said.

"Should growth in the NIH budget be reinstated in future years, one of the highest priorities will be to target those additional resources to HIV vaccine programs, particularly vaccine discovery research," the health officials wrote.

Copyright © 2008 Associated Press

http://www.cbsnews.com/blogs/2008/07/25/primarysource/entry4292347.shtml

July 25, 2008, 8:50 AM
 
 
Debate Over Vaccines And Autism/ADD 
 
 
Posted by Sharyl
<javascript:loadAuthor('primarysource',%20501263,%20'Sharyl_Attkisson')>
Attkisson|
<http://www.cbsnews.com/blogs/2008/07/25/primarysource/entry4292347.shtml#cc
mm> Comments5
 
 
 
 
 
http://www.cbsnews.com/images/2008/03/06/image3915706l.jpg
 
(AP)
 
The debate over vaccines and autism/ADD is so sensitive that for some who
are directly affected: it's gotten personal. No more personal, perhaps, than
for the parents of Hannah Poling. Hannah developed autism as a toddler after
a battery of vaccines. In a landmark case last fall, the federal government
(which defends vaccines in federal vaccine court) quietly conceded that
vaccinations resulted in Hannah's autism. The government has portrayed
Poling's case as an exception because she had an undiagnosed condition (that
may have been pre-existing): mitochondrial disorder. Many scientists and
government officials agree with vaccine makers in portraying Poling as a
"special case" that can "not be extrapolated to other vaccine-autism cases."
 
 
But the concession was significant for many reasons. First, for a decade the
government has insisted there is no possible link between vaccines and
autism, but was now conceding-- and agreeing to pay damages-- in such a
case. Even if the case is some sort of "exception," it runs counter to the
longstanding claim that no possible link exists. Simply put: the old
position was "there's no way vaccines can result in autism," but the
government's new position seems to be, "it may have happened once but it
doesn't really mean anything in the big picture." Second, Hannah was an
autism "test case" in federal vaccine court. By conceding the case, the
government avoided a test case trial that -- by its own calculations -- the
government would likely have lost. Hannah's case would have then served as a
high-profile precedent, giving guidance on any other cases similar among the
thousands of autism claims pending in vaccine court. 
 
When news that the government had conceded Hannah's case leaked out to the
public a few months ago, those who reject any possible link between vaccines
and autism/ADD went on the offensive. Among other things, they worry that if
parents are needlessly scared away from vaccinations, they will stop
immunizing and risk deadly diseases re-emerging into our society. 
 
Yale University School of Medicine academic clinical neurologist, Dr. Steven
Novella writes a blog that covers news and issues in neuroscience. He
recently posted <http://www.theness.com/neurologicablog/?p=339>  commentary
about what he calls, celebrities "promoting the false controversy about a
link between vaccines and autism." 
 
Hannah's Father, Dr. Jon Poling, a neurologist and a PhD, wrote a letter
<http://www.cbsnews.com/htdocs/pdf/072408_vaccines_autism.pdf>  to Dr.
Novella that shows just how complex the scientific question of Autism is.
Poling writes, "Regarding your entry on Hannah's case, your blog entry
unfortunately propagates several of the mistakes from the media." 
 
Some unresolved questions that are being asked in the debate: Was Hannah's
mitochondrial disorder a biological weakness that was exploited by vaccines,
resulting in autism? If so, does that confirm Hannah was an exception and
other children are not to worry? Does it imply there is a small subset of
children with unknown and known biological and genetic weaknesses who could
similarly be at special risk when vaccinated? As of now, according to
government officials, they are not studying cases of alleged autism
resulting from vaccine damage. In fact, the government told CBS News it has
not even tracked how many brain damage claims that have been paid in federal
vaccine court resulted in autism. As the former head of the National
Institutes of Health, Dr. Bernadine Healy has said: perhaps some answers to
the autism/ADD mystery are waiting, but you have to go looking to find them.
 
 
Watch the CBS Evening News tonight for Sharyl's Follow the Money
Investigation on some of the surprising places where vaccine industry money
ends up. 

A Statement from Wendy Fournier, NAA President 
 
For the last week, our community has been completely enveloped in the
Michael Savage controversy. It infuriates me that this one man has managed
to take away so much of our already limited time and energy by forcing us to
defend ourselves and our beloved children against his vile remarks.
 
When I first became aware of Savage's comments, I immediately got in touch
with Mark Masters, the CEO of Talk Radio Network and Savage's boss. Mark was
aware of the comments but had not yet listened to the show. We spoke for a
long while and I quickly came to realize that I was speaking to a kind and
compassionate husband and father. Mark said that while he hadn't yet heard
the tape, he suspected that Savage was talking about one of the issues that
bothers him most, the over-diagnosing and drugging of children in America,
and that it was possible that his remarks were being taken out of context.
Having dealt with the media and having seen the ridiculous way members of
our own community have been edited to look like crazy, desperate parents, I
was open to the idea that Mark's suggestion may have been a possibility.
Mark promised to speak with Savage and to give us the opportunity to refute
his comments on the air.
 
On Monday evening, Mark fulfilled his promise and I was able to speak with
Savage on his show. Leaving the door open to the chance that he was indeed
taken out of context, I pushed my anger toward him aside and discussed with
him many of his views about healthcare in America and the sad reality that
families affected by autism face. Savage has several problems with the
medical community in general that I personally agree with, the most
frustrating of which is the over-zealous desire to drug our children.
 
However, when it came to Savage's views on Autism specifically, he was
completely misinformed and off the mark. 
 
He believes that autism is being over-diagnosed. There may be a relatively
small number of children who are wrongly diagnosed with an ASD, but for the
most part, an autism diagnosis is not something that is given lightly. Those
of us whose children have been through the evaluation process know that it
is extensive.
 
On the subject of diagnosis, our kids are diagnosed based on observation of
skills and behaviors. All the while, the medical community completely fails
to investigate what might be causing those behaviors. This needs to change.
We need research to turn away from number-crunching epidemiological studies
and the search for the elusive Autism gene, and start looking from a
biological standpoint at the children who are currently affected. Your child
may very well meet the current diagnostic criteria for Autism, but what if
he or she is really suffering from heavy metal toxicity or auto-immune
encephalopathy, for example? Those illnesses are known to cause symptoms of
Autism. If your doctor kept digging to find the cause of your child's
neurological dysfunction, you would likely come out on the other side with a
treatable illness and hope for the future, not to mention health insurance
coverage for treatment. But instead, you are told that your child has
autism, there is no treatment, hurry to get on a waiting list for behavioral
therapies. Mainstream physicians need to start recognizing and treating the
underlying medical issues that are causing the symptoms we collectively
observe and diagnose as autism, only then will we start to make some real
progress. My hope is that one day, no child will be diagnosed with "Autism",
that all sick children will be properly diagnosed and successfully treated
for the illnesses that they truly suffer from.
 
Back to Savage and his misconceptions, this one is almost amusing. He
actually thinks that having a child with autism opens the door to free
medical treatment and services from the government, suggesting that parents
might actually push for a diagnosis in an effort to screw the government and
our fellow taxpayers. Those of us in the trenches know that the word
"autism" is the last thing a parent wants to hear. Savage's implied freebies
are nowhere to be found. The minute your child is diagnosed, you need to fit
yourself with a suit of armor, a shield and a big-ass sword, because you
have just taken the first step into a never-ending fight to get the services
and medical care that your child needs. Our kids are placed on waiting lists
for services that can be years long, our health insurance companies turn
their backs on us, and our overwhelmed and under-funded school districts
force us to fight for even the most basic services to help our kids. The
number of families facing bankruptcy and losing their homes to provide their
children with the care they need is staggering. 
 
Savage also thinks that greedy lawyers are somehow involved, looking for
ways to milk the pharmaceutical companies for families who claim that
vaccines caused their child's regression. He is completely ignorant to the
fact that manufacturers are protected from all liability on vaccine injury
claims thanks to the National Vaccine Injury Compensation Program. I tried
to point this out to him, but he pushed on with this false assumption. What
I didn't realize until hearing the show later, was that my phone line was
completely muted when Savage was speaking. There were several times when I
tried to interject and disagree with him, and I was simply not heard. This
is misleading and my silence could be interpreted by some of his listeners
as agreement. I'm not happy about that.
 
Savage's producer asked me to have several other guests from our community
standing by to be interviewed during the show. I did that, and not one of
them was included. The callers who were put on the air appeared to be
hand-selected to participate in the show with the sole purpose of allowing
Savage to backtrack and basically cover his own behind.
 
Savage claims to be an advocate for children's health. One might think that
instead of ranting about bad parenting, he would be questioning why we have
so many sick children in this country. Coinciding with the increase in
recommended vaccines, we've had an increase in chronic diseases including
Asthma, ADD, ADHD, Juvenile Diabetes, and yes, Autism. Why do our government
health agencies refuse to compare the overall health outcomes of vaccinated
versus unvaccinated children? Why do they continue to inject our babies with
substances that are known to be toxic to the developing brain and immune
system? Why is our government being allowed to treat an entire generation of
children like lab rats, by requiring an ever-increasing number of vaccines
and conducting absolutely no safety studies on their cumulative effects?
 
Last night, I received an email with a link to a new website,
savageonautism.com. He's got a website for this now? On this site, there is
a link to an audio clip of my discussion with Savage. It noted, "Savage
speaks with Wendy Fournier, President of the National Autism Association who
says that she has much common ground with Savage". Again, misleading. I do
not appreciate the implication that I am in any way on his side and I will
not be used as a pawn in his attempt to backtrack on his comments. I
contacted Talk Radio Network about this and the reference was promptly
removed. 
 
Mark Masters from TRN has offered to air public service announcements on
their nationally syndicated shows in an effort to educate listeners on the
reality of autism. For that I am very grateful. I hope that it will undo
some of the damage that has been done.
 
That damage is very real, and it frightens me for our children. I just got a
phone call from a 74-year-old lady from California who was literally
screaming at me, saying that we are a bunch of hysterical mothers who refuse
to discipline our kids. She could barely catch her breath, and she's calling
us hysterical? I ended up hanging up on her and she's called back 6 times
already - that's how fired up and anxious she is to criticize us as parents
and the children we love. This is the damage that Mike Savage has done,
whether he meant to or not is completely irrelevant. There are people out
there who are taking his words at face value and his message is one of hate.
 
 
To the fine people who are sending me hate mail about freedom of speech, you
can stop. I'm all for it. You can say anything you want to in this country,
but if you choose to attack our kids, be ready to defend your comments.
We're already suited up and are getting pretty good at wielding our big-ass
swords.
 
In closing, I have listened with an open mind to Savage's claim that he was
taken out of context. My personal conclusion is that he was not, he's lying
to us. There are several reasons why I don't believe him, but I keep coming
back to one very significant quote. Savage claims he was talking about the
"misdiagnosed", not kids that truly have autism. But during his deplorable
rant he said, "What do you mean they scream and they're silent?" He was
talking then about children who are silent, children who are non-verbal,
children who are severely affected by autism, children like my beautiful
little girl.
 
Michael Savage, take your father's advice. Don't act like a moron. You'll
get nowhere in life. Stop acting like a putz. Straighten up. Act like a man.
Whether you actually meant to hurt suffering families or not, the simple
fact is, you did hurt us. And for that alone, you should man up and
apologize.
 
Wendy Fournier, President
National Autism Association
wendy@nationalautism.org 

http://www.aidsinfobbs.org/periodicals/beta/21

Human Herpesvirus Type 6 (HHV-6): Cofactor or Opportunistic
Infection in AIDS?

Ronald A. Baker, PhD

     Ronald Baker is editor of BETA.

     A recent post-mortem study of lung, lymph node, spleen,
liver and kidney tissues of 9 people with AIDS revealed that
every tissue examined (34 of 34) was positive for active HHV-6
infection (Knox and Carrigan, 1994).  Based on these and other
results from their study, a research team at the Medical College
of Wisconsin concludes that HHV-6 is an important disease-causing
agent in people with AIDS.

     The HHV-6 infection rate was significantly higher in the
tissues examined than that for cytomegalovirus (CMV), which was
present in only 9 of the 34 tissues.  HHV-6 infection of the lung
of one individual was extensive enough to account for his fatal
pneumonitis, according to the investigators.

Background

     HHV-6 is a commonly found virus that infects at least 90% of
the general population in the U.S. by age 2, and is widely and
highly prevalent in many parts of the world.  HHV-6 was first
discovered in 1986 at the Tumor Cell Biology Laboratory of the
National Cancer Institute (Bethesda, Maryland) by Dr. Zaki
Salahuddin and colleagues (Salahuddin, 1986).

     The potential pathogenic role of HHV-6 is not yet clearly
understood, but there is suggestive evidence that the virus may
play a significant role in several diseases.  Researchers have
conclusively linked the virus to only one disease_exanthem
subitum (roseola), a benign illness of early childhood associated
with primary HHV-6 infection.  As with other herpesviruses,
available serologic tests have limited value in differentiating
between latent (inactive) and active infection with HHV-6.  Only
recently have researchers developed and employed special
techniques that can detect HHV-6 replication in vivo
(immunohistochemical staining with a specific polyclonal
antiserum).

     Dr. Robert Gallo and colleagues at the National Cancer
Institute (NCI) suggested 5 years ago that HHV-6 might contribute
to the depletion of CD4 cells (T-helper cells) in people with
AIDS.  These government researchers found that, like HIV (but
unlike CMV), HHV-6 selectively infects CD4 cells.  They also
discovered that, in laboratory tests of HIV and HHV-6 coinfected
cells, HHV-6 stimulates the release of cytokines that activate
HIV replication.  Thus, HHV-6 and HIV can coinfect individual
lymphocytes and cause increased cytopathic changes in these
immune system white blood cells, when compared to lymphocytes
infected only with HIV.  HHV-6 also induces CD8 cells and natural
killer (NK) cells to express the CD4 receptor (the major receptor
of HIV), thus increasing the number of cells susceptible to
infection with HIV.

Natural Killer Cellsand HHV-6

     Natural killer cells provide the body with an important
mechanism of primary defense against infection with viruses.
When natural killer cell functioning is significantly compromised
or reduced (as in AIDS), the natural immunity of the individual
is seriously impaired.  For example, multiple herpesvirus
infections occur in individuals who congenitally lack natural
killer cells.  [Ed.  note:  a reduced natural killer cell
function has been documented not only in AIDS but also in chronic
fatigue syndrome (CFS), a disorder of unknown cause that often
presents with signs of active HHV-6 infection.]

     In laboratory tests, HHV-6 can directly target and kill
natural killer cells.  In humans, this could result in the
suppression of the individual's natural antiviral immunity.
HHV-6 is the only virus known that efficently infects and kills
natural killer cells, according to NCI researchers.

Disseminated, Active HHV-6 Infection

     Researchers in the Department of Pathology at the Medical
College of Wisconsin evaluated the frequency of active HHV-6
infection in 9 people who died of AIDS.  The demographic data of
these individuals closely resembled that of the general
population of HIV positive individuals in Wisconsin.  As
mentioned above, every tissue examined was positive for active
HHV-6 infection, while CMV infection was found in only 9 of the
34 tissues examined.

     The investigators conclude that HHV-6 was probably the cause
of one individual's fatal pneumonitis.  They point out that
respiratory failure is the main cause of death in AIDS patients,
with pneumonitis of unknown cause being the primary cause of
death in 5-10% of people with AIDS. They suggest that HHV-6
infection may be the cause of the fatal pneumonitis in some of
these individuals.

     Most of the HHV-6-infected cells in tissues of AIDS patients
examined were lymphocytes.  HHV-6-infected lymphocytes located
within areas of inflammation, suggest the researchers, could
transfer the infection to other lymphocytes, thereby perpetuating
the inflammation and causing a significant systemic destruction
of lymphocytes.

     The lymphoid organs are important reservoirs of HIV
infection, and recent studies have demonstrated that HIV
infection is active and progressive in lymphoid tissue during the
clinically latent stage of HIV disease.  The Wisconsin
pathologists note that HHV-6-infected lymphocytes account for the
increased density of HHV-6 infection found in the lymphoid
organs.  HHV-6 can infect and destroy CD4 cells, and when HHV-6
and HIV infect the same CD4 cells, the destruction of these cells
is enhanced by mechanisms not yet understood.

Other Evidence of the Interaction between HHV-6 and HIV-1

     Many isolates of HHV-6 have been drawn from the lymphocytes
of people with an AIDS diagnosis.  Because the primary cellular
target of both HHV-6 and HIV is CD4 cells, it has been suggested
that HHV-6 may be a cofactor in progression to AIDS.  The
manifestations of such a role might include the following
criteria:  (1) changes in HHV-6 antibody levels as AIDS
progresses; (2) changes in levels of HHV-6 in tissues or bodily
fluids; and (3) evidence for interactions between the viruses at
the cellular or molecular levels (Pellet, 1992).

     The study of HHV-6 in people with HIV disease has yielded
uncertain results.  Published reports include evidence of a high
seroprevalence of HHV-6 and/or increased antibody titers in
people with AIDS (Levy, 1990); no differences in immune profiles
(Balachandran, 1991); no significant differences in HHV-6
antibody titer between HIV positive and random male blood donors
(Brown, 1988); lower prevalence of HHV-6 in AIDS patients; and no
difference between antibody titers of HIV positive
lymphadenopathy patients who did or did not progress to AIDS
(Spira, 1990).

     In laboratory tests of cell cultures coinfected with HIV and
HHV-6, a wide range of effects have been found.  Individual CD4
cells can be simultaneously infected with both viruses, with the
coinfected cells demonstrating increased HIV activity, increased
reverse transcriptase levels and earlier cell death (Lusso,
1989).  Lusso and colleagues found that HHV-6 induced the
expression of the CD4 receptor in lymphocytes, making these cells
more susceptible to infection with HIV (Lusso, 1991). Other
experiments have shown suppression of HIV replication in cells
coinfected with HHV-6 and HIV (Carrigan, 1990).  HHV-6
replication in these cells was unaffected or only slightly
enhanced.  It was even suggested that HHV-6 may slow the
progression of disease in some HIV positive individuals.

Chronic Fatigue Syndrome

     Several studies have noted higher HHV-6 antibody titers or
seroprevalence in people diagnosed with chronic fatigue syndrome
(Krueger, 1987; Read, 1988; Balachandran, 1991).  In a controlled
study, HHV-6 antibodies were detected in 69% of the cases and in
only 12.5% of the controls (Dale, 1989).  In contrast, one study
found no difference in seroprevalence between cases and controls
(Wakefield, 1988), and another noted no correlation between HHV-6
seroprevalence or antibody titers and chronic fatigue syndrome
(Gold, 1990).

Immune Response

     HHV-6 induces the increased expression of several cytokines,
including interferon alpha, interleukin-1B and tumor necrosis
factor (Kikuta, 1990; Flamand, 1991).  HHV-6 may produce an
immunomodulatory effect by stimulating the production of these
cytokines, which, in turn, may result in disease progression
(Carrigan, 1991), viral avoidance of immune surveillance
(Flammand, 1991) or stimulation of viral activity (Folks, 1989).

Other Disease Associations

     As mentioned above, HHV-6 infection occurs early in life,
and has been shown to be the cause of a mild disease in children,
exanthem subitum (roseola or sixth disease).  In addition,
significant increases in anti-HHV-6 titers have been found in
several types of transplant recipients whose immune systems were
suppressed by chemotherapy:  cardiac (Irving, 1988), bone marrow
(Asano, 1991), liver (Ward, 1989) and renal (Asano, 1989).

     In a study of 15 bone marrow recipients, only one
participant was culture-positive for HHV-6, suggesting that
active HHV-6 infection is not common among this patient
population.  HHV-6-infected lymphocytes were detected in the
lungs of 2 bone marrow transplant recipients who developed
pneumonitis, but the lung tissue cells had no evidence of HHV-6
infection, suggesting that disease resulted from HHV-6-associated
inflammation rather than cell destruction by the virus.  It is
clear that HHV-6 can become active due to post-transplant
immunosuppression, but its role in causing complications
following transplantation is unclear.  There is evidence
suggesting a role for HHV-6 in some adult cases of hepatitis
(Dubedat and Kappagoda, 1989).  Researchers also have reported an
association of HHV-6 with cases of mononucleosis-like illnesses
that did not appear to result from infection with Epstein-Barr
virus (EBV) or CMV (Irving and Cunningham, 1990).  HHV-6 was
cultured from the blood of a patient with a severe
mononucleosis-like illness, elevated numbers of activated B
cells, depressed numbers of T-cells, extremely high titers of
anti-HHV-6 antibodies, and who met the case definition of chronic
fatigue syndrome (Buchwald and others, 1991).

Immune Disorders and Lymphoproliferative Diseases

     The first 6 isolates of HHV-6 were taken from individuals
with lymphoproliferative disorders (Salahuddin, 1986), but the
role of HHV-6 in immune disorders and lymphoproliferative
diseases is uncertain. Individuals with autoimmune diseases
(e.g., sarcoidosis, Sjogren's syndrome and systemic lupus
erythematosis) reportedly have higher than normal HHV-6 antibody
titers (Ablashi, 1988).  Researchers found that patients with
leukemia and lymphoma had higher anti-HHV-6 titers than controls,
with the highest titers among those with acute myeloid leukemia,
Hodgkin's disease and non-Hodgkin's lymphoma (Clark, 1990).
Others have also noted higher HHV-6 antibody titers in people
with Hodgkin's disease (Balachandran, 1991).  It is possible
that, even if HHV-6 does not play a direct causative role, the
virus may be a cofactor in the progression of these diseases.
Some researchers have suggested that HHV-6 may stimulate the
production and activation of B-cells, thus expanding the
population of cells targeted by another pathogen or event that
gives rise to malignant lymphomas.

Treatment Implications

     The possible involvement of HHV-6 in serious illnesses has
motivated a search for antivirals to inhibit its replication.
The results of HHV-6 susceptibility to antivirals is summarized
in Table I. Although it is difficult to compare the results due
to the variety of assays, viral strains and culture conditions,
some conclusions can be drawn. Ganciclovir (GCV), foscarnet (PFA)
and phosphonoacetic acid clearly inhibit almost all HHV-6
replication, indicating that the virus is susceptible to similar
antivirals as cytomegalovirus.  HHV-6 is also sensitive to
acyclovir (ACV), although somewhat less than to the other
antivirals shown.  It is possible that acyclovir (Zovirax) at
doses adequate to suppress herpes simplex virus infection (oral
and genital herpes) also might have an inhibitory effect on the
reactivation of HHV-6.  The effect of the new acyclovir prodrug
valacyclovir (Valtrex) in HHV-6 has not yet been studied.
Because Valtrex produces significantly higher blood levels of
acyclovir than Zovirax, it may effectively suppress the activity
of HHV-6.

Commentary

     If the destruction of CD4 cells caused by coinfection with
HHV-6 and HIV seen in laboratory tests also occurs in vivo, the
result of this coinfection in the lymphoid organs could be the
synergistic destruction of CD4 lymphocyte cells.  This process,
in turn, would eventually result in the progressive
disintegration of the immune system.

     Conclusive evidence demonstrating an immunosuppressive role
for HHV-6 in AIDS is not yet available.  It is possible that the
widespread reactivation of HHV-6 infection shown by Knox and
Carrigan may result from the immunodeficiency caused by HIV
infection, but in his commentary on the Wisconsin post-mortem
study, Dr. Gallo suggests that the reactivation of HHV-6 over the
course of HIV infection may significantly increase disease
progression:  "...the unique biological properties of HHV-6,
especially its 'immunotropic' nature and its positive
interactions with HIV, strongly suggest that, once reactivated in
the course of HIV infection, it may have detrimental effects on
the immune system and expedite progression of the disease."

     "How can we solve this puzzle that may have critical
implications for the prophylaxis and management of AIDS?
Longitudinal studies of HHV-6 replication in HIV-infected people
are essential to establish a solid association with disease
progression.  Nevertheless, valuable information can be expected
from other approaches_for example, coinfection studies in animal
model systems...and therapeutic trials of drugs with selective
activity against HHV-6" (Gallo and Lusso, 1994).

Conclusion

     Although a good deal has been learned about HHV-6 in a short
period of time, much significant information remains unclear or
unknown. Researchers have presented data suggesting HHV-6
involvement in a number of diseases, but it is unlikely that the
virus plays a causative or cofactor role in all of them.  The
evidence for a cofactor role for HHV-6 in HIV disease progression
is suggestive, but inconclusive.  HHV-6 may be an opportunistic
infection, like so many others in AIDS.  Controlled clinical
trials will be necessary to clarify further what role, if any,
HHV-6 plays in HIV-associated immune dysfunction.

Sources

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Asano Y and others.  Reactivation of herpesvirus type 6 in
children receiving bone marrow transplants for leukemia.  New
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Balachandrian N and others.  Electrophoretic analysis of human
herpesvirus 6 polypeptides immunoprecipitated from infected cells
with human sera.  Journal of Infectious Diseases 163:  29-34.
1991.

Brown NA and others.  Prevalence of antibody to human herpesvirus
6 among blood donors infected with HIV.  The Lancet ii:  1146.
1988.

Carrigan DR and others.  Suppression of human immunodeficiency
virus type-1 replication by human herpesvirus-6.  Journal of
Infectious Diseases 162: 844-851.  1990.

Carrigan DR and others.  Interstitial pneumonitis associated with
human herpesvirus-6 infection after marrow transplantation.  The
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Corbellino M and others.  Disseminated human herpesvirus 6
infection in AIDS. The Lancet 342:  1242.  1993.

Dale JK and others.  The Inoue-Melnick virus, human herpesvirus
type 6, and the chronic fatigue syndrome.  Annals of Internal
Medicine 110:  92-93.  1989.

Drobyski WRR and others.  Human herpesvirus 6 (HHV-6) infection
in allogeneic bone marrow transplant recipients I:  evidence for
a marrow-suppressive role for HHV-6 in vivo.  Journal of
Infectious Diseases 167:  735-739.  1993.

Dubedat S and Kappagoda N.  Hepatitis due to human herpesvirus-6.
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Flamand L.  Human herpesvirus 6 induces interleukin-1B and tumor
necrosis factor alpha, but not interleukin-6, in peripheral blood
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Folks TM and others.  Tumor necrosis factor alpha induces
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Gold D and others.  Chronic fatigue.  A prospective clinical and
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Knox KK and Carrigan DR.  Disseminated active HHV-6 infections in
patients with AIDS.  The Lancet 343:577-578.  March 5, 1994.

Krueger GRF.  Persistent fatigue and depression in a patient with
antibody to human B-lymphotropic virus.  The Lancet ii:  36.
1987.

Levy JA and others.  Frequent isolation of HHV-6 from saliva and
high seroprevalence of the virus in the population.  The Lancet
335:  1047-1050. 1990.

Lusso P and others.  Productive dual infection of human CD4 T
lymphocytes by HIV-1 and HHV-6.  Nature (London) 337:  370-373.
1989.

Lusso P and others.  Induction of CD4 and susceptibility to HIV-1
infection in human CD8+ T lymphocytes by human herpesvirus 6.
Nature (London) 349: 533-555.  1991.

Lusso P and others.  Infection of natural killer cells by human
herpesvirus 6.  Nature 362:  458-462.  April 1, 1993.

Lusso P and Gallo RC.  Human herpesvirus 6 in AIDS.  The Lancet
343:  555-556. March 5, 1994.

Lusso P.  Interactions between HHV-6 and HIV:  HHV-6 as a
potential cofactor in AIDS.  In:  Interactions between
retroviruses and herpesviruses.  Kung HJ, Wood C, eds.  River
Edge, New Jersey.  World Scientific Publishing (in press).

Pellet PE and others.  Human herpesvirus 6:  the virus and the
search for its role as a human pathogen.  Advances in Viral
Research 41:  1-51.  1992.

Salahuddin SZ and others.  Isolation of a new virus, HBLV, in
patients with lymphoproliferative disorders.  Science 234:  596-
601.  1986.

Wakefield D.  Human herpesvirus 6 and myalgic encephalomyelitis.
The Lancet i:1059.  1988.

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seropositive donor.  Journal of Medical Virology 28:69-72.  1989.

---------

Inhibition of HHV-6 Growth by Antiviral Drugs


Inhibitory
Drug    Virus strain   Cells    dose (fM)   Inhibition  (%)

PFAa    African        PBL           83            100
HBLV    HSB-2        104            100
PAAb    Z29            PBL         2141             88
Z29     CBL          714            100
Roseola CBL          357            100
Z29     CBL          200            100
ACVc    Z29            PBL          400             85
OK      CBL          444            100
Z29     CBL           50             88
KF      PBL          128             90
African PBL          100            100
HBLV    HSB-2e       0.4             80
GCVd    African        PBL           10            100
KF             PBL            6            100
Z29            CBL           25             94
HBLV           HSB-2        0.6              0

a Phosphonoformate       c Acyclovir     e Drug was cytotoxic
b Phosphonoacetic acid   d Ganciclovir

Dynavax inks flu vaccine deal with Novartis

San Francisco Business Times - by Steven E.F. Brown

EU food safety experts say NO to cloned meat

By Sean Poulter Last updated at 10:06 PM on 24th July 2008

Calls for clone farming to be banned were stepped up yesterday after an official study highlighted animal suffering and food safety risks.

The European Food Safety Authority found that animals involved in cloning suffer pain and ill-health linked to miscarriages, organ defects and gigantism.

It also flagged up the possibility that clones and their offspring could pass animal diseases to humans through meat and milk.

Cloned pigs: A study has found animals involved in cloning suffer ill-health

The inquiry was launched in January 2007 after the Daily Mail highlighted the fact that Dundee Paradise – the offspring of a clone – had been born on a British farm.

Last month, the Mail reported that a total of eight 'clone farm' calves have now been born on British farms. 

Frozen embryos taken from the clones of prize-winning Holstein cows in the U.S. were flown to the UK and implanted into farm animals.

Advocates claim it will allow prize-winning animals to be copied to create a new generation of animals, able to produce vast quantities of milk or lean meat.

But the report by the EFSA, set up in 2002 to improve EU food safety, said: 'The health and welfare of a significant proportion of clones have been found to be adversely affected, often severely and with a fatal outcome.'

Professor Vittorio Silano, of the EFSA, said: 'It is clear there are significant animal health and welfare issues for surrogate mothers and clones that can be more frequent and severe than for conventionally-bred animals.'

The cloning process involves taking the nucleus of cells from the ear of an animal and implanting them in an egg from a female. The fertilisation process is kick-started with an electric charge.

There are large number of miscarriages of embryos. Organ defects lead to death in pregnancy or soon after birth.

EFSA said clones are also more likely to show 'gigantism'. They are so large the only way they can be born is through caesarean section.

The study highlighted the need to find out why clones and their offspring are more vulnerable to some diseases and if these could be a food safety threat. T

he report said: 'It should be investigated whether consumption of meat and milk derived from clones or their offspring may lead to increased exposure to transmissable agents.' 

The developments in clone farming have outpaced moves by the British Government and EU to put in place a policing mechanism.

There is no system to monitor the existence and welfare of clones and their offspring. Nor is there any system to ensure that meat and milk from these animals is labelled to inform shoppers.

The final decision on whether to allow clone farming and food rests with the European Commission.

Peter Stevenson of Compassion in World Farming, said: 'Britain and the EU should ban cloning, not just farming but also food from cloned animals and their offspring because of the very serious health and welfare issues.'

RSPCA senior scientist, Dr Nikki Osborne, said: 'The RSPCA believes cloning of animals for food production should be banned on animal welfare and ethical grounds.'

Sue Davies, Chief Policy Adviser at consumer group Which?, said: 'This EFSA opinion highlights why it is far too premature to think about using cloned animals for food production.'

Director of Eurogroup for Animals, Sonja Van Tichelen, said: 'The EU is now obligated to follow its own rules. Under the general farm directive a breeding technique that causes suffering should not be allowed.'

Last night Defra said it would expect food companies or farmers to seek advice from the Government before attempting to put meat and milk from clones or their offspring on the market.

Are GM Crops Killing Bees?

By Gunther Latsch

A mysterious decimation of bee populations has German beekeepers worried, while a similar phenomenon in the United States is gradually assuming catastrophic proportions. The consequences for agriculture and the economy could be enormous.
Walter Haefeker is a man who is used to painting grim scenarios. He sits on the board of directors of the German Beekeepers Association (DBIB) and is vice president of the European Professional Beekeepers Association. And because griping is part of a lobbyist's trade, it is practically his professional duty to warn that "the very existence of beekeeping is at stake."

The problem, says Haefeker, has a number of causes, one being the varroa mite, introduced from Asia, and another is the widespread practice in agriculture of spraying wildflowers with herbicides and practicing monoculture. Another possible cause, according to Haefeker, is the controversial and growing use of genetic engineering in agriculture.

As far back as 2005, Haefeker ended an article he contributed to the journal Der Kritischer Agrarbericht (Critical Agricultural Report) with an Albert Einstein quote: "If the bee disappeared off the surface of the globe then man would only have four years of life left. No more bees, no more pollination, no more plants, no more animals, no more man."

Mysterious events in recent months have suddenly made Einstein's apocalyptic vision seem all the more topical. For unknown reasons, bee populations throughout Germany are disappearing -- something that is so far only harming beekeepers. But the situation is different in the United States, where bees are dying in such dramatic numbers that the economic consequences could soon be dire. No one knows what is causing the bees to perish, but some experts believe that the large-scale use of genetically modified plants in the US could be a factor.

Felix Kriechbaum, an official with a regional beekeepers' association in Bavaria, recently reported a decline of almost 12 percent in local bee populations. When "bee populations disappear without a trace," says Kriechbaum, it is difficult to investigate the causes, because "most bees don't die in the beehive." There are many diseases that can cause bees to lose their sense of orientation so they can no longer find their way back to their hives.

Manfred Hederer, the president of the German Beekeepers Association, almost simultaneously reported a 25 percent drop in bee populations throughout Germany. In isolated cases, says Hederer, declines of up to 80 percent have been reported. He speculates that "a particular toxin, some agent with which we are not familiar," is killing the bees.

Politicians, until now, have shown little concern for such warnings or the woes of beekeepers. Although apiarists have been given a chance to make their case -- for example in the run-up to the German cabinet's approval of a genetic engineering policy document by Minister of Agriculture Horst Seehofer in February -- their complaints are still largely ignored.

Even when beekeepers actually go to court, as they recently did in a joint effort with the German chapter of the organic farming organization Demeter International and other groups to oppose the use of genetically modified corn plants, they can only dream of the sort of media attention environmental organizations like Greenpeace attract with their protests at test sites.

But that could soon change. Since last November, the US has seen a decline in bee populations so dramatic that it eclipses all previous incidences of mass mortality. Beekeepers on the east coast of the United States complain that they have lost more than 70 percent of their stock since late last year, while the west coast has seen a decline of up to 60 percent.

In an article in its business section in late February, the New York Times calculated the damage US agriculture would suffer if bees died out. Experts at Cornell University in upstate New York have estimated the value bees generate -- by pollinating fruit and vegetable plants, almond trees and animal feed like clover -- at more than $14 billion.

Scientists call the mysterious phenomenon "Colony Collapse Disorder" (CCD), and it is fast turning into a national catastrophe of sorts. A number of universities and government agencies have formed a "CCD Working Group" to search for the causes of the calamity, but have so far come up empty-handed. But, like Dennis vanEngelsdorp, an apiarist with the Pennsylvania Department of Agriculture, they are already referring to the problem as a potential "AIDS for the bee industry."

One thing is certain: Millions of bees have simply vanished. In most cases, all that's left in the hives are the doomed offspring. But dead bees are nowhere to be found -- neither in nor anywhere close to the hives. Diana Cox-Foster, a member of the CCD Working Group, told The Independent that researchers were "extremely alarmed," adding that the crisis "has the potential to devastate the US beekeeping industry."

It is particularly worrisome, she said, that the bees' death is accompanied by a set of symptoms "which does not seem to match anything in the literature."

In many cases, scientists have found evidence of almost all known bee viruses in the few surviving bees found in the hives after most have disappeared. Some had five or six infections at the same time and were infested with fungi -- a sign, experts say, that the insects' immune system may have collapsed.

The scientists are also surprised that bees and other insects usually leave the abandoned hives untouched. Nearby bee populations or parasites would normally raid the honey and pollen stores of colonies that have died for other reasons, such as excessive winter cold. "This suggests that there is something toxic in the colony itself which is repelling them," says Cox-Foster.

Walter Haefeker, the German beekeeping official, speculates that "besides a number of other factors," the fact that genetically modified, insect-resistant plants are now used in 40 percent of cornfields in the United States could be playing a role. The figure is much lower in Germany -- only 0.06 percent -- and most of that occurs in the eastern states of Mecklenburg-Western Pomerania and Brandenburg. Haefeker recently sent a researcher at the CCD Working Group some data from a bee study that he has long felt shows a possible connection between genetic engineering and diseases in bees.

The study in question is a small research project conducted at the University of Jena from 2001 to 2004. The researchers examined the effects of pollen from a genetically modified maize variant called "Bt corn" on bees. A gene from a soil bacterium had been inserted into the corn that enabled the plant to produce an agent that is toxic to insect pests. The study concluded that there was no evidence of a "toxic effect of Bt corn on healthy honeybee populations." But when, by sheer chance, the bees used in the experiments were infested with a parasite, something eerie happened. According to the Jena study, a "significantly stronger decline in the number of bees" occurred among the insects that had been fed a highly concentrated Bt poison feed.

According to Hans-Hinrich Kaatz, a professor at the University of Halle in eastern Germany and the director of the study, the bacterial toxin in the genetically modified corn may have "altered the surface of the bee's intestines, sufficiently weakening the bees to allow the parasites to gain entry -- or perhaps it was the other way around. We don't know."

Of course, the concentration of the toxin was ten times higher in the experiments than in normal Bt corn pollen. In addition, the bee feed was administered over a relatively lengthy six-week period.

Kaatz would have preferred to continue studying the phenomenon but lacked the necessary funding. "Those who have the money are not interested in this sort of research," says the professor, "and those who are interested don't have the money."

Translated from the German by Christopher Sultan

The director of the University of Pittsburgh Cancer Institute and UPMC Cancer Centers plans to issue an advisory to about 3,000 faculty and staff today about the possible health risks associated with cellular phone use.

"Recently I have become aware of the growing body of literature linking long-term cell phone use to possible adverse health effects including cancer," Dr. Ronald Herberman said in the memorandum. "Although the evidence is still controversial, I am convinced that there are sufficient data to warrant issuing an advisory to share some precautionary advice on cell phone use."

The advisory suggests certain measures to limit exposure to electromagnetic radiation emitted by the devices, such as shortening the length of conversations or keeping the phones away from the head by text messaging or using headsets or speaker phone options. It also recommends that children not use cell phones except in emergencies.

A child's developing organs "are the most likely to be sensitive to any possible effects of exposure," according to the document.

In an interview, Dr. Herberman said he hoped the suggestions would spread to others within Pitt and the University of Pittsburgh Medical Center, as well as to the general public.

He noted that other countries have recommended limits on exposure, and that in Canada, public health officials in Toronto have advised young people to limit cell phone use.

But while there is growing support for limited use, it is not universal.

There is nothing wrong with taking precautions, but "the bottom line, at this time, is that there is no conclusive evidence tying cell phone use to brain cancer," said Dan Catena, a spokesman for the American Cancer Society.

Dr. Herberman believes he is the first U.S. cancer center director to approve the release of such an advisory. And a spokesperson for the National Cancer Institute said officials there were unaware of similar advisories issued by other center directors.

No other major U.S. health care or consumer group has gone as far in advocating for precautions, said Dr. Louis Slesin, editor of Microwave News, which tracks research related to cell phone safety.

Dr. Herberman also has signed on, along with more than 20 other international experts, to a document calling for precautions in using the devices.

Many are from Europe, but they also include several with U.S. ties. Among them are Dr. David Servan-Schreiber, a Pitt medical school professor who spends much of his time in France, and Dr. Devra Davis, director of the Pitt Cancer Institute's Center for Environmental Oncology.

Dr. Servan-Schreiber, a brain cancer survivor, said he solicited experts to support the document, and Dr. Herberman credited Dr. Davis with drawing his attention to the recent research findings.

Release of the document in France last month drew considerable attention from the news media, Dr. Slesin said.

Some of the concerns about cell phone use have come from preliminary data from the 13-country study of cell phone use and tumors known as the Interphone study, he said.

Release of the overall findings has been delayed for more than two years. But a group of European countries has reported an elevated risk for certain brain tumors among long-term cell phone users, particularly on the side of the head where the phone was used, he said.

A separate group of Swedish researchers reported similar findings, Dr. Slesin said.

"From a public health perspective, it makes sense to limit risks," said Dr. Dan Wartenberg, director of environmental epidemiology at the University of Medicine and Dentistry of New Jersey and one of the international experts calling for precautions.

The group also wants manufacturers to provide phones "with the lowest possible risk" and to "encourage consumers to use their devices in a way that is most compatible with preserving their health."

"We do not need to ban this technology, but to adapt it -- to harness it -- so that it never becomes a major cause of illness," the group noted.

But others question the need for action.

While suggestions that cell phones may be linked to cancer have been around for years, "the science remains so sketchy," said Dr. Matt Quigley, surgical director of neuro-oncology at Allegheny General Hospital.

"The overwhelming majority of studies that have been published in scientific journals around the globe show that wireless phones do not pose a health risk," CTIA-The Wireless Association, a group representing the wireless industry, said in a statement. Joe Fahy can be reached at jfahy@post-gazette.com or 412-263-1722

FDA, CDC back Merck's Gardasil shot as safe

Fresh scent may hide toxic secret

Innocuous-sounding 'perfume' in detergents, air fresheners made with dangerous chemicals

By LISA STIFFLER
P-I REPORTER

The scented fabric sheet makes your shirts and socks smell flowery fresh and clean. That plug-in air freshener fills your home with inviting fragrances of apple and cinnamon or a country garden.

But those common household items are potentially exposing your family and friends to dangerous chemicals, a University of Washington study has found.

Trouble is, you have no way of knowing it. Manufacturers of detergents, laundry sheets and air fresheners aren't required to list all of their ingredients on their labels -- or anywhere else. Laws protecting people from indoor air pollution from consumer products are limited.

When UW engineering professor Anne Steinemann analyzed of some of these popular items, she found 100 different volatile organic compounds measuring 300 parts per billion or more -- some of which can be cancerous or cause harm to respiratory, reproductive, neurological and other organ systems.

Some of the chemicals are categorized as hazardous or toxic by federal regulatory agencies. But the labels tell a different story, naming only innocuous-sounding "perfume" or "biodegradable" contents.

"Consumers are breathing these chemicals," she said. "No one is doing anything about it."

Industry representatives say that isn't so.

"Dr. Steinemann's statement is misleading and disingenuous," said Chris Cathcart, president of the Washington, D.C.-based Consumer Specialty Products Association, in a statement.

"Air fresheners, laundry products and other consumer specialty products are regulated under the Federal Hazardous Substances Act and subsequently have strict labeling requirements," he said. "Companies producing products that are regulated under FHSA must name on the product label each component that contributes to the hazard."

Millions are spent annually to ensure that fragrances in the products are safe, according to a joint statement from the Fragrance Materials Association, which represents fragrance manufacturers, and the Research Institute for Fragrance Materials, which works closely with the association.

Ingredients are routinely tested, and chemicals that are considered dangerous are present at levels much too low to cause harm, according to the groups.

But there are numerous reports of people -- particularly those with asthma, chemical sensitivities and allergies -- having strong adverse reactions, researchers said.

That's a problem when public restrooms in restaurants or airplanes use air fresheners, or when hotels wash towels and sheets in scented laundry supplies. And even when the concentrations are low in individual products, people are exposed to multiple sources on a daily basis.

Aileen Gagney, Asthma and Environmental Health Program manager with the American Lung Association in Seattle, herself an asthma sufferer, has a rule of thumb to help avoid exposure: "If it smells bad, it's bad; if it smells good, it's bad."

But even that won't always work.

According to Steinemann, even products labeled "unscented" sometimes contain a fragrance and a "masking" fragrance to make them odor-free.

People, Puget Sound at risk?

For Steinemann's research, published Wednesday in Environmental Impact Assessment Review, she selected a top-selling item from six categories of products: dryer sheets, fabric softeners, detergents, and solid, spray and plug-in air fresheners.

Then she contracted with a lab to test the air around the items to identify the chemicals people could be breathing.

Ten of the 100 volatile organic compounds identified qualified under federal rules as toxic or hazardous, and three of those -- 1,4-dioxane, acetaldehyde and chloromethane -- are "hazardous air pollutants" considered unsafe to breathe at any concentration, according to the study.

The labels gave no indication that the irritating and potentially dangerous chemicals were present, so Steinemann checked the product's Material Safety Data Sheets. These technical documents provide ingredient information for the safety of workers and emergency responders. They, too, disclosed little detail, mostly citing ingredients such as "essential oils" and "organic perfume."

"It's a reasonable expectation to think that laundry products and air fresheners would be free of chemicals that can cause cancer," said Erika Schreder, a staff scientist with the Washington Toxics Coalition.

"But as this UW study shows, it's disturbingly easy to find toxic chemicals in everyday products like these because companies don't have to say what's in their products."

Cathcart, of the Consumer Specialty Products Association, said the information's not on the package because the "chemicals are not present in the products at levels deemed hazardous under the law. Given the limited space on product labels, it is important to include the relevant information consumers need to make intelligent use, storage and disposal decisions."

The threat isn't limited to people. Steinemann and others worry that the chemicals in consumer products flow from homes to the outdoors.

"These chemicals get into our water systems and into Puget Sound," she said. They are "extraordinarily hard to get out of the environment."

Steinemann's research was paid for using discretionary money awarded to her as a UW professor; she wanted to avoid any appearance of a conflict of interest. She has also submitted for publication a study that goes further to examine ingredients in cleaning and personal-care products.

Regulatory gaps

With fears growing over chemicals in consumer products -- lead in toys, bisphenol A in plastic baby bottles, phthalates in shower curtains and cosmetics -- environmentalists and health advocates are calling for stricter regulations of chemicals in everyday goods. They also want shoppers to have more readily accessible information.

Manufacturers and trade groups representing consumer products routinely counter that there's plenty of testing and oversight from within the industries and from government regulations to ensure safety.

In the fragranced-products arena, they point to industry Web sites with information on product ingredients and suggest contacting companies with specific questions.

Critics maintain that's not enough.

"There's obviously a loophole," said Michael Robinson-Dorn, a UW law professor who aided Steinemann's research. "We regulate many of these chemicals in other circumstances, yet when they're in products that we're in contact with daily, in some cases, we don't wind up finding out about them."

He said the items can slip between regulatory cracks by falling into the jurisdiction of multiple government agencies, none taking ownership.

"Any time you have a product that is regulated by many different agencies, it's easy for them not to react," he said.

In the absence of strong laws, the marketplace is starting to regulate itself.

After the Natural Resources Defense Council last fall found troubling levels of phthalates -- plasticizing chemicals that can potentially harm developing babies -- in air fresheners, Walgreens pulled the products from its shelves.

Last month, NRDC and other environmental groups sued the Environmental Protection Agency to force manufacturers to test air freshener safety and label products with a full ingredient list.

Steinemann's study could push the process along.

"Consumer demand for less-toxic products will encourage companies to reformulate their products," she said. "This is a case where a little information could have a great public benefit."

Allergen-free GM plants may boost food safety: experts

By Stephen Daniells

21-Jul-2008 - Advances in the field of genetic engineering may produce plants with little or no allergens, but there are limits to this approach, say Australian researchers.

BPA was found in approximately 90% of urine samples in Americans studied.^[21] Recent studies suggest it may also be linked to obesity^[22] by triggering fat-cell activity^[23] and have confirmed that bisphenol A exposure during development has carcinogenic effects and produce precursors of breast cancer.^[24][25]

In 2007, a consensus statement by 38 experts on bisphenol A concluded that average levels in people are above those that cause harm to animals in laboratory experiments,^[28] and a panel convened by the U.S. National Institutes of Health determined that there was "some concern" about BPA's effects on fetal and infant brain development and behavior.^[5] A 2008 draft report by the U.S. National Toxicology Program (NTP) agreed with the panel, concluding that "there is some concern for neural and behavioral effects in fetuses, infants, and children at current human exposures," and that there is "some concern for bisphenol A exposure in these populations based on effects in the prostate gland, mammary gland, and an earlier age for puberty in females."

Human exposure to bisphenol A

Bisphenol A has been known to leach from the plastic lining of canned foods ^[51] and, to a lesser degree, polycarbonate plastics that are cleaned with harsh detergents or used to contain acidic or high-temperature liquids. Studies by the CDC found bisphenol A in the urine of 95% of adults sampled in 1988-1994^[52] and in 93% of children and adults tested in 2003-04.^[53] Almost all exposure is through diet, and infants fed with liquid formula are among the most exposed. Infants fed canned formula with polycarbonate bottles can consume quantities of bisphenol A up to 13 µg/kg/day,^[54] while the most sensitive animal studies show effects at much lower concentrations. Debate continues on what is the safe limit of this compound. Within the United States, an exposure of up to 50 µg/kg/day (50 ppb/day) is considered safe^[32] by the United States Environmental Protection Agency.^[55]References

Spacehab Eyes Biomedical Research Opportunities Aboard ISS

For years scientists had to beg for access to the space shuttle to conduct microgravity research, until a well-timed salmonella discovery helped cinch a spot for Spacehab Inc. on all but one of the shuttle's remaining scheduled flights.

"The timing couldn't have been better," Spacehab President Jim Royston said June 16, two days after Space Shuttle Discovery returned from the international space station with test tubes of the salmonella bacteria.

Amid growing concern about salmonella outbreaks and an increase in the bacteria's resistance to existing medicine, Spacehab sent a second round of salmonella vaccine research to the space station May 31. Previous tests have shown salmonella is more virulent in microgravity, although scientists are not sure why.

Royston leaves the increased virulence question to scientists. His mission now is to take results of the Discovery mission, which validated similar findings aboard Endeavour in March, to the U.S. Food and Drug Administration. He hopes the agency will allow Spacehab to begin human trials of a salmonella vaccine by October.

The Webster, Texas-based company has a list of 20 other infectious diseases to send to the space station for vaccine research. On each of 10 upcoming shuttle flights, Spacehab will send between eight and 16 of its Group Activation Packs — polycarbonate cylinders containing eight 114-millimeter test tubes. With the turn of a handle, an astronaut will release bacteria-eating worms and growth nutrients from one end of each test tube to mix with disease-causing bacteria in a separate compartment at the other end of the tube. The packs also have a motor and can be activated remotely.

"Salmonella is a good bacteria to prove that our system is stable and reliable," Royston said. "We've shown it's extremely reliable, it meets all requirements and opens the door to move other vaccine candidates through this pipeline."

Through a partnership with the U.S. Department of Veterans Affairs, Spacehab will share its research but retain commercial rights. Veterans Affairs may use the data to conduct its own research or to treat its patients, Royston said, adding that in exchange, Spacehab has access to VA facilities.

A medical breakthrough such as the discovery of a salmonella vaccine could generate enthusiasm in the community of scientists who previously faced limited space access while the shuttle transported massive parts for space station construction. With the $100 billion space station nearly complete and its designation as a National Laboratory, new opportunities have emerged.

"Before, we had no destination. The shuttle was doing its best to do simple research," Royston said. "Now all of the sudden with the space station completion ... we have open-door access to what is probably mankind's greatest achievement."

NASA has made about half of its space station research space available to commercial enterprise through the National Laboratory, which will go a long way with reluctant investors, Royston said. Once the shuttle is retired, Spacehab can fly experiments to the space station on the Russian-built Soyuz and Europe's Automated Transfer Vehicle. Soyuz can return small samples, while other samples will produce data that can be recorded and retrieved without returning the samples, he said.

"If the market is there then the capability is there to do it. That's what we're trying to show on this first one," he said. "We see it as a tool to get better data faster."

In May, Spacehab established a subsidiary, BioSpace Technolgies Inc., for its biotechnology research — both space-based and on the ground. The company, headed by Royston for now, hired as its chief science officer Jeanne Becker, vice president and associate director of the National Space Biomedical Research Institute in Houston.

Spacehab's efforts have drawn support from the state of Florida, which has lured major biotechnology companies to a 23-county high-tech corridor stretching from coast to coast in North and Central Florida, and includes Cape Canaveral Air Force Station. The state's space arm, Space Florida, has committed $90,000 to the salmonella project, and Steve Kohler, president of Space Florida, plans to ask his board to approve $210,000 more.

"This is exposing an opportunity to connect space-related research and a customer group that might not otherwise be thinking about it, like biotech and pharmaceutical companies," Kohler said. "We can connect these kinds of opportunities to the international space station."

The partnership brings more than just money. As part of the agreement, Spacehab research can be conducted at Florida's Space Life Sciences Laboratory, a $30 million facility at Cape Canaveral. The lab can provide ground control and data transmission for on-orbit experiments and pre- and post-flight integration, Kohler said.

Royston said the partnership opens access to Florida's research institutes, large pharmaceutical companies and universities.

"The value of the partnership is immeasurable for what it brings," Royston said.

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http://www.floridatoday.com/apps/pbcs.dll/article?AID=/20080606/NEWS02/806060332/1007/news02

Space worms get sick for people

Insects infected with salmonella to find vaccine for humans

BY PATRICK PETERSON • FLORIDA TODAY • June 6, 2008

CAPE CANAVERAL -- Some worms that flew to space aboard shuttle Discovery are making a sacrifice to help mankind.

In an experiment to help find a vaccine against salmonella, tiny C. elegans worms will be exposed to the bacteria, which becomes three times more virulent in microgravity.

The experiment in space is similar to one that flew aboard the Discovery mission in March.

This second flight should validate the information from the first experiment, moving scientists closer to a vaccine.

"It's a piece of a puzzle. We don't come back with a vaccine," said Thomas Pickens III, chairman and chief executive officer of SPACEHAB Inc., which is sponsoring the experiment. "I don't think that we are very far away from it."

Space Florida, a state government agency charged with promoting space-related economic development, has invested $90,000 in the multi-
million dollar effort, in hopes of creating space biotechnology jobs in Florida.

"Validating a model for vaccine development on this mission opens the door to help people live healthier lives, build a new industry related to pharmaceutical development and drive diversity in aerospace economic development," Space Florida president Steve Kohler said.

By studying increased virulence and its effect on the worms at the gene level, scientists hope to develop a salmonella vaccine more quickly.

Pickens said a vaccine could be ready for market in two to three years.

A vaccine against salmonella could save many lives worldwide, especially among small children in developing countries, and make a profit for the company.

"Space is a short-cut," Pickens said.

The salmonella experiment has ridden to the International Space Station with the Japanese Kibo laboratory, which will be the largest module at the station.

The experiment was arranged under a new agreement to help scientists and industry use the space station for experiments.

With the installation of the European Columbus laboratory and the massive Japanese Kibo laboratory, the space station has greatly increased the amount of space available for scientific work.

As part of the arrangement to launch the modules, the U.S. controls half of the space for science in both modules.

Next spring, the crew of the space station will increase to six, providing more manpower for science as well.

Contact Peterson at 639-3644 or ppeterson@floridatoday.com