FDA Recommends US Allow Use of Rotavirus Vaccines While Safety Being Studied
From Jennifer Corbett-Dooren of the Wall Street Journal
http://online.wsj.com/article/BT-CO-20100507-716126.html?mod=WSJ_latestheadlinesWASHINGTON

(Dow Jones)–A Food and Drug Administration panel said Friday fragments of pig viruses found in vaccines used to protect infants against rotavirus didn’t appear to cause health risks.

While the panel didn’t take a vote on the products, several members of the agency’s vaccine panel said the vaccines — Merck & Co.’s (MRK) Rotateq and GlaxoSmithKline PLC’s (GSK, GSK.LN) Rotarix — should remain on the U.S. market while additional studies are conducted about the impact of pig viruses.

In the meantime, the panel said parents who are considering whether to vaccinate their infants need to be informed about the findings.

FDA panels are made up of non-FDA medical experts and are called upon to make nonbinding recommendations to the agency.

Karen Midthun, acting director of FDA’s Center for Biologics and Research, said the agency would be “very expeditious” in making recommendations about whether either vaccine should be used. n March, the FDA recommended that doctors stop using Glaxo’s vaccine after a team of researchers from the University of California in San Francisco found DNA of a porcine circovirus known as PCV1 in the vaccine. Those tests didn’t find the same pig virus in Merck’s Rotateq.

However, on Thursday the FDA said more sensitive tests subsequently conducted on Rotateq found a “low level” of the same PCV1 virus, as well as a related porcine circovirus known as PCV2. Both viruses are common in pigs — and neither is known to cause illness in humans — but PCV2 may cause illness in pigs.

The FDA said it wouldn’t decide whether it would recommend that use of Merck’s Rotateq be suspended or whether it would lift its suspension recommendation involving Glaxo’s Rotarix in advance of the meeting. The panel meeting had originally scheduled to discuss Rotarix but also included Rotateq in light of similar findings about pig virus fragments discovered in the product.

“PCV is not infectious in humans,” said Harry Greenberg, a panel member and medical professor at Stanford University. “The benefits far outweigh the risks.”

Both the Glaxo and Merck vaccines are designed to protect infants from a gastrointestinal illness caused by rotavirus and have been given to millions of babies. While rotavirus is rarely fatal in the U.S., it contributed to about 70,000 infant hospitalizations annually before Merck’s vaccine was approved in 2006 and Glaxo’s in 2008.

Umesh Parashar, an epidemiologist at the Centers for Disease Control and Prevention, said the most recent agency data looking at the impact of the vaccines in the U.S. show “almost…a complete wipeout of rotavirus activity.” Parashar deemed rotavirus “a major killer” of children in parts of the world that can’t adequately treat dehydration from severe diarrhea.

One theory about how pig virus fragments got into the vaccine offered by both the FDA and the companies is that PCV fragments might be in trypsin, an enzyme derived from pigs that is used in the manufacturing process of the vaccine. The enzyme is used to grow viruses used in the vaccines.

Barbara Howe, a GlaxoSmithKline vice president in the company’s vaccine division said, “all available data support PCV1 in Rotarix is a manufacturing quality issue, not a safety issue.” She said the company is working on ways to remove PCV from the vaccine but that developing a new manufacturing process “is complex and will take time.”

Frontline’s “The Vaccine War” Misses Half the Story
http://www.huffingtonpost.com/jenny-mccarthy/ifrontlineis-the-vaccine_b_555785.html
Jenny McCarthy.Author, model and autism activist
Posted: April 28, 2010 03:21 PM

When the producers of PBS’s Frontline approached me to be interviewed for their new documentary “The Vaccine War,” I accepted with a simple condition: doctors and scientists on our side of the vaccine-autism debate needed to have a voice, too.

Prior to agreeing to the interview, Frontline sent us this email:

“Frontline will carry out a detailed and even-handed investigation including voices from all sides of the controversy including parents, activists, physicians, scientists, lawyers, politicians and vaccine manufacturers.”

I’ve learned to be wary of media who try to simplify the vaccine-autism debate into a “Parents vs. the Science” spin, so I went further and agreed to do the interview only if Dr. Jay Gordon, a well-known pediatrician here in Los Angeles, sat beside me. (Dr. Jay also sat for his own two hour interview.)

For those who’ve watched the show, you know that the Frontline producers broke their promise and presented our entire community’s position through my interview and just two other parents — Barbara Loe Fisher and J.B. Handley.

Where are the doctors and scientists who support our community and support the idea that vaccines may be a trigger for autism? In Frontline’s world, they don’t exist.

Imagine how much more credible the countless stories of children regressing into autism after vaccine appointments would be if a doctor were saying the same thing.

Luckily for all of us parents, Dr. Gordon has not stayed silent since the show aired. In a piece for HuffPost earlier this week, he wrote:

“Vaccines are neither all good — as this biased, miserable PBS treacle would have you believe…You had a point to prove and removed material from your show which made the narrative balanced. ‘Distraught, confused moms against important, well-spoken, calm doctors’ was your narrative with a deep sure voice to, literally, narrate the entire artifice.”
Also missing from Frontline were interviews from any of the dozens of scientists who have published studies in medical journals supporting the position of all the parents.

And, where was Autism Speaks, the largest autism organization in the world, and a group that hasn’t been a huge supporter of our community?

Maybe Frontline had seen a recent letter written by Dr. Geraldine Dawson, the chief science officer of Autism Speaks, where she wrote:

“Recent studies point to a key role of the immune system in the biology of ASD [autism], raising questions about the effects of the significant immune challenges associated with vaccinations, particularly when delivered in combination and early in life…We believe that the question of whether immunization is associated with an increased risk for ASD is of extremely high priority.”
Frontline’s trip to Denmark to interview a scientist was meant to convince parents that vaccines have been studied all over the world and so they must be safe.

What Frontline didn’t mention was that the Danish scientist interviewed works for a vaccine maker, that the paper discussed showed Denmark’s rate of autism at 1 in 2,500 (versus the U.S. rate of 1 in 100) or that Denmark’s vaccine schedule for kids is 12 shots versus 36 here in the U.S.

And, parents hear nothing about the Danish scientist’s colleague and co-author Poul Thorsen, who recently stole $2 million from the CDC and is reportedly on the run from authorities.

When Dr. Wakefield is profiled, there’s no recent interview with him to tell his story, just old media clips and one side’s take. What about Dr. Wakefield’s recent work finally comparing vaccinated monkeys with unvaccinated monkeys?

Frontline’s piece also lacked any sense of proportion. Yes, a wave of twelve children with measles in San Diego is a troubling thing. But, there are more than 20,000 children in San Diego with autism! 20,000 vs. 12? When you really look at the numbers, you realize how huge our autism problem really is.

I believe our bloated vaccine schedule has created a scenario where there is now too much of a good thing. All drugs have side-effects, particularly if many are given at one time. Why should vaccines be any different?

The Frontline viewer heard nothing about the more than 1,000 reported deaths from vaccination or the nearly $2 billion paid by the US government to vaccine injury victims.

If the risk of vaccinating is really a 1 in 100 chance of a child getting autism, what will happen to the vaccine program?

Cooler heads need to get involved with this problem, rather than multi-millionaire vaccine inventors. Dr. Bob Sears, another doctor interviewed by Frontline but cut out of the actual show, offered a possible solution:

“In my mind, the only way we’d really put this issue to rest is to do a very large scientific study that looks at hundreds of thousands of children who are vaccinated versus hundreds of thousands of children that are not vaccinated, and we compare the rates of autism in those two groups.”
I was encouraged at the end of the show when the health officials complained about the power and existence of the Internet, as if immediate information were somehow a threat to the vaccine program.

Parents, when people are blaming a problem on the availability of information — like China trying to keep their population in the dark — you know there’s a bigger problem, and another side to the story — a side that Frontline knowingly chose not to share.

Help children with autism by voting for Generation Rescue!

Frontline’s Producer Feeds the “Hungry Lie”
http://www.ageofautism.com/2010/05/frontlines-producer-feeds-the-hungry-lie.html

By J.B. Handley

The “hungry lie” on autism is both maddeningly simple and simply maddening and goes something like this: “It’s been asked and answered, vaccines don’t cause autism.”

As I’ve written about repeatedly, this is a huge lie, a critical lie, and a very “hungry” lie, because it constantly needs to be fed. Thanks to Frontline’s recent show, “the Vaccine War,” many more people will be confronted with this lie and have to sort through the rhetoric to figure out what is actually true.

Jon Palferman, who produced Frontline’s “The Vaccine War,” is different from many of the other feeders of the hungry lie in one important way: he spent nearly 2 hours sitting in my office debating and learning more about this very topic. I am certain that he fully and completely understands that only a single vaccine on the US vaccine schedule has actually been studied for its relationship to autism. I’m also certain he realizes many public health officials make bold and untrue statements all the time to reassure the public that “vaccines” have been studied and rendered “safe.”

To me, this makes Mr. Palferman’s recent public comment all the more unconscionable. On Frontline’s website, as a response to Dr. Jay Gordon’s searing critique of Frontline’s decision to not air any of Dr. Gordon’s taped interview, Mr. Palferman issued the following statement:

“Many thanks for your feedback on the program. FRONTLINE went to considerable lengths to include a wide range of viewpoints, even in the face of very strong scientific evidence against the hypothesized autism link to MMR and thimerosal. Despite the consistent negative epidemiology and the definitive verdict of the federal vaccine court, we included views from people who wanted more and different studies. The program also gave a great deal of time to the arguments of vaccine hesitant parents who think the CDC schedule is bloated. The companion FRONTLINE website contains full interviews with different stakeholders, including Dr Robert Sears, who promotes an alternative spread out vaccine schedule. The website also hosts a robust public conversation where a full range of viewpoints are being aired and engaged.”

Let me repeat for you the part of Mr. Palferman’s statement that shows he did spend 2 hours with me, but wanted to defend his position anyway:

“the hypothesized autism link to MMR and thimerosal”

You see, Mr. Palferman fully gets that no one has shown “vaccines don’t cause autism,” because I personally hammered home the point to him until he finally got it. So, he’s smart enough not to fully repeat the simple hungry lie that “vaccines” have been studied and at least tells the truth that ONLY thimerosal and the MMR have been looked at.

But, Mr. Palferman is still feeding the hungry lie through his statement, because he’s implying that somehow the meager amount of science on 2 of 36 shots our kids are given somehow implies that the position of our community is resting on shaky ground. And, he’s well aware that mainstream voices will support his statement, because they are all heavily invested in the same hungry lie. It’s a simple way for him to get out of the middle of the firing line.

* *

The hungry lie is so obvious to me, I struggle sometimes to see why it’s constantly repeated without anyone getting called out for saying it. Am I not communicating this clearly enough? Is there a better way to explain it?

In Jenny McCarthy’s recent HuffPo editorial criticizing Frontline, there is a trail of comments that approaches the hungry lie in a different way that makes the point with even more detail–perhaps reviewing it will highlight the issue.

SingaporeAutismDad writes:

Here’s first 12 months of vaccines for American children:
Birth: Hep B
2 months: Hep B, Rotavirus, DTaP, Hib, PCV, IPV
4 months: Rotavirus, DTaP, Hib, PCV, IPV
6 months: Hep B, Rotavirus, DTaP, Hib, PCV, IPV, Flu
12 months: MMR, Hib, PCV, Varicella, Hep A, Hep B

For all you scientists out there, how many of these shots have been studied for relationship to autism? One. So, here’s the schedule in first 12 months of shots kids get that HAVE NOT been studied. Are you still a scientist?

Birth: Hep B
2 months: Hep B, Rotavirus, DTaP, Hib, PCV, IPV
4 months: Rotavirus, DTaP, Hib, PCV, IPV
6 months: Hep B, Rotavirus, DTaP, Hib, PCV, IPV, Flu
12 months: Hib, PCV, Varicella, Hep A, Hep B

I thought this was great. As you can see, MMR was pulled from the second list, leaving 24 vaccines by 12 months of age that have NOT been looked at for their relationship to autism. How does an honest scientist argue with this point?

Well, the appropriately named “Mikerattlesnake” gave it his best shot:

“yes, the ONE that anti-vaxers were clammoring for to be tested ad nauseum, by the way. When a link failed to emerge, when none of the data pointed to a link beyond a simple correlation, when the proponents of the link were shown to be frauds, etc, etc, etc, it probably lost a bit of priority. Money should be spent on studies that show some promise. This link shows no promise.”

This “link” shows no promise? We have tens of thousands of case reports of declines after vaccine appointments, absolutely no science that remotely reflects the experience of our kids, but the link shows no promise? So far, that’s about the only argument I’ve heard that tries to defend studying only one of the first 25 vaccines our kids get. Most just try to avoid the question, because it’s so indefensible.

SinaporeAutismDad then asks a more clear-headed commentor named Schwartzz the following:

“Schwartzz: You make a lot of sense. Perhaps comment on why so few shots have been studied? Why do they give 20 shots in the first year of life, only study one, and say “case closed”? Is this American science, or Big Pharma science? I don’t understand it.”

Schwartzz responds:

“It’s quite simple: Because they don’t need to study them. Why would any corporation spend money on something that in the best case maintains the status quo and in the worst case costs them a fortune?

What you have is purely a product of the system that is setup to regulate medicine. It isn’t a conspiracy at all. It is the natural outcome of a flawed system.”

I couldn’t have said it any better myself.