PENTACEL! AAP IS PLEASED!

By Kim Stagliano

An unnamed AAP official celebrates the announcement of a new Five in One vaccine called, "Pentacel."   Read the FDA sheets HERE.  When the article says, "could reduce the number of injections" that doesn't mean fewer vaccines, it means fewer needles. Tricky sticky, yes? Don't fall for it.

MONDAY, June 23 (HealthDay News) -- The U.S. Food and Drug Administration has approved Sanofi Pasteur's Pentacel combination vaccine for children, the company said Monday.

Approved as a four-dose series at 2, 4, 6 and 15 to 18 months of age, it protects against diphtheria, tetanus, whooping cough (pertussis), polio, and influenza type B. Use of the vaccine could reduce the number of injections children get before they are 18 months old by as many as one-third -- from 23 shots to 16, Sanofi said in a statement.

Read the full article from the Atlanta Journal Constitution HERE.

 

Due to budget constraints, we were only able to poll one infant about Pentacel. However, she seems to sum up her thoughts quite succinctly.

Kim Stagliano is Managing Editor of Age of Autism.

Comments

[Monica]

Ok, well, they did actually use my comments regarding Jade's reaction, and contraindication in the on-air broadcast, but only list the politically-correct version online (which of course promotes pentacel as if it were gold).

I have given as much info as I can for now on the article- perhaps others may care to contribute!

http://www.tampabays10.com/news/local/story.aspx?storyid=83785&catid=8

[MOnica]

Our local station, who also hosts www.momstampabay.com (a very open mass media forum that speaks openly about the dangers of vaccines, and other mothering topics) is running a story today at 4 on pentacel. Ironically, AoA is often mentioned there.

I hope my friends at TampaBays10 have committed to spreading the truth!

Here is a thread the producer (who is also expecting) started regarding pentacel, and today's show.
http://forums.momstampabay.com/viewtopic.php?t=3326

As soon as today's show is linked, I will link up.

[Riley's mom]

I have yet to read the whole article but the problem was I got to the baby picture and the comment with it and haven't been able to stop laughing or get the tears out of my eyes long enough to read it!!!
Well, the message isn't getting thru at all. It's not the "jabs" our kids receive that we worry about. So what, they cut it from a whopping 23 to a still whopping 16 before they are 18 months. It's still the same sh*t just a different spin. I honestly don't understand how they get away with this.

[angela s]

Pentacel is being promoted all over the local news channels. Let's hope people listening ask WTH!!!

[pinkdove]

those pictures are fantastic. only real laugh i've had all day.

[Teresa Conrick]

Thanks SAM for your thoughts re Tetramune. I actually found a creepy vaccine timeline
http://www.immunize .org/timeline/
that showed it appeared on the radar the year Meg was born, 1993, and was then disappearing into the horizon before my 2nd daughter, Mary, was born in 1995. That is a short span of shelf time so I do wonder what was happening behind the scenes.

[Twyla]

Keep in mind that infants are already getting 7 or 8 vaccines at 2 mos & 4 mos, according to the CDC's schedule -- the five which are in Pentacel, plus Pneumococcal, Rotavirus, and HepB. At six months they get most of these plus their first flu shot.

My point is not that Pentacel is o.k., but that babies are already receiving so many at one time. On the plus side, maybe there's just one dose of the adjuvants etc. But if doctors stock Pentacel and not individual vaccines, it will be that much more difficult for parents to have the schedule spread out and slowed down.

[SAM]

DTwP-HIB, Diphtheria, Tetanus, Whole-cell Pertussis and Haemophilus Influenza B conjugate. It had 25 mcg of thimerosal too.

Sigh, you really couldn't win, back then, could you, Teresa?. My ds didn't get that one, but in early 1995 and throughout that year, he received the dtWp with 25 mcg. of hg, and the Hib with 25 mcg's of hg. So he got the whole cell dtp, plus the extra hg in the Hib (and the heb B hg too, of course). But, I'll bet they were already realizing that the tetramune was causing big problems, yet weren't ready to roll out the dtAp yet.

[AJ]

"The vaccine should not be administered to infants who developed Guillain-Barré syndrome after a prior tetanus vaccine, or if a serious adverse reaction was noted after a prior whooping cough vaccine, the company said."

If they are starting the shot at 2 months, how the heck will they let anyone develop Guillain-Barre or have an adverse reaction to the whooping cough vaccine. I thought there was no whooping cough vaccine because it needs the D and the T along with it.

Why the pretend safeguards when they know this is going to kill many many babies or permanently maim them? Do they still not understand how dangerous these combo vaccines are? What's it going to take to "get" a simple message? How many deaths is good enough?

[Teresa Conrick]

linda-

Saw you comment re Tetramune. Megan also had that 4x. For those who don't know, DTwP-HIB, Diphtheria, Tetanus, Whole-cell Pertussis and Haemophilus Influenza B conjugate. It had 25 mcg of thimerosal too. I often wonder how many severe cases of autism came about like Megans (birth-1993)from it. Somewhere around 1994/95, it began to disappear and be replaced with the acellular,,Prohibit and Trihibit. My 2nd daughter, born in 1995 did not get Tetramune, or autism.

[Gayle]

Hours, later, Kim, I am still laughing at the pictures you selected. Absolutely nothing else is funny, though, I must say (except for Jeanne's wonderfully astute monkey baby comment).

[Elucidatus]

I love that picture. That is the picture that should be on the label of the Pentacel. Also, there should be one of those really cheesey commercials of some knucklehead doctor describing the symptoms of the side effects with the parents sitting in the doctor's office just nodding their heads as agreeing. This is it people. This is the vaccine that is going to make headlines. 5 in 1 should only be for a Swiss Army knife not a vaccine.

[linda]

That's how the Tetramune was sold to me- it will be less injections! My son ended up with a massive brain hemorrhage! Thank God I don't participate any longer in the government's experiment on our children!

[Garbo]

I guess the marketing department is running the AAP these days. They've realized they have a hard time selling a bazillion vaccines to parents of infants. Why don't they just get it over with and make one ginormous syringe? I'm sure Paul Offit would approve.

RE: Free samples, Carrie; speaking for me only, I can see the value in helping out patients who might be on limited financial means by giving free samples, but personally I have found that whatever "free" samples I've gotten have been for newer, more costly drugs that work no better or in some cases less well than existing medications. I get irritated every time I'm at my doctor's office and see it wall to wall with notepads, pens, and pencil cups emblazoned with the logo of a particularly expensive drug she prescribed for me a while back that gave me terrible side effects. It makes me wonder whether her prescribing decisions are made with patients in mind or profits.

[Harry Tembenis]

Let's not forget Pediatrix, another 5 in 1 combo:

http://www.centerwatch.com/patient/drugs/dru815.html

...and let's also not forget how many fathers are most likely sitting in jail for "shaken baby syndrome" when most likely they walked into their child having a seizure following immunizations in the same day and were trying to perform CPR on the child but were scapegoated instead to cover up the reaction...

[Angela S.]

Wait a minute! Isn't this the vaccine that showed negative effects when tested? Seizures, I think. I'm searching for info about this but having no luck.

I am so worried about the parents who will fall for this.

However more and more parents are questioning vaccines every day, so perhaps it won't make the AAP as happy as they think.

Hopefully this will backfire in their face when people who've been questioning whether or not to have their child vaccinated hear about this and say "WTF"!! (I would imagine many will think this).

This could just work in our favor!

[Concerned Mom in North Dakota]

This is for not only Carrie but all of humanity: Re: proceeds from Jenny's book not going to support autism. (She seems to have donated her life to the cause and is getting the word out there more than anyone or any group to date) We all need to ask ourselves how we can help, if we can donate time, money or medical expertise. Or babysitting so these parents can get a breather. Or home cooked (healthy) meals.

I have 3 healthy children, none with autism. But when my daughter began kindergarten last year I learned there were 3 in her class with autism (I am aware of only 3) and became concerned even more so with this EPIDEMIC. I joined an autism support group to promote awareness and see what I Personally can do to put an end to this. Because really we all can make a difference in inching our way along. We forget the POWER each of us has. And that Combined POWER...

And I firmly believe this ball will keep a rollin' and not STOP until the truth is evident for EVERYONE to FINALLY SEE.

[Stagmom]

Cathy, different set of vaxes. Yeah, I know. So????

They're trying to fool parents into thinking their babies are getting fewer vaccines. Read the press release: "Reducing the number of injections..." Other releases will substitute a more ambiguous, "the number shots" and most parents will be duped. But not if they read A of A!

Best,

KIM

[Cathy]

Pardon my ignore, but I thought I read, maybe even on AOA, that the study for the quad shot of MMRV was stopped due to unnervingly (my word) high incidence of seizure activity attributed to the nice and neat one shot vaccine. So why would they continue research on a pent shot? The insanity continues to amaze me...

[Sakura]

Kelli Ann, you bring up some great points. In addition, what about premature infants? I can pretty much guarantee that all of the pre-licensure trials were done on healthy, full-term babies. If they vaccinate according to chronological age (which is the norm), then some babies that receive this vaccine will not even be "full term" when they receive this vaccination. It makes me sick to think of these fragile preemie babies getting stuck with 5 vaccines at once when they are still not even gestationally "full term". Heartbreaking. THIS is "medicine" and "science"?

[Kelli Ann Davis]

Check this out from the FDA approval letter:

Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of administration are required to contain an assessment of the safety and effectiveness of the product for the claimed indication(s) in pediatric patients unless this requirement is waived, deferred or inapplicable.

**We are waiving the pediatric study requirement** for this application for ages 0-5 weeks (i.e., before age 6 weeks) and 5-16 years (i.e., 5 years to prior to 17 th birthday) because:

A) In the pediatric population 0-5 weeks of age, necessary studies are impossible or highly impracticable because neither diphtheria, tetanus, nor poliomyelitis occur in U.S. infants too young to be protected from vaccination beginning at 6 weeks of age.

B) In the pediatric population 0-5 weeks of age, Pentacel® does not represent a meaningful therapeutic benefit over initiating vaccination against diphtheria, tetanus, and poliomyelitis at 6 weeks of age and ****IS NOT LIKELY TO BE USED**** in a substantial number of pediatric patients ages 0-5 weeks.

Two Questions:

1.) Who determined that *6 weeks* is the magical number when an infant is able to handle a boatload of vaccines? I mean really, what difference is 7 days gonna do when they're that young??? Heck, why not just shoot them up at 5 weeks?

2.) What happens if a doctor administers this vaccine at say.....5 1/2 weeks? Wouldn't that be *unethical* considering there were never any safety tests done on this population???

The words *not likely* seems to indicate that the FDA realizes that infants within this age group WILL be given the vaccine -- but most won't.

So what happens if the doc isn't *strictly* following the schedule?? Would it be breaking the law if the shot is given too early???

I mean heck, you don't get to legally drink alcohol unless your 21. It doesn't matter if your birthday is a week away -- the establishment could still get their license revoked if they serve you alcohol.

So what happens in this case? Is the doc going to get in trouble for administering a vaccine on an infant who's too young to receive it??

[hmmmm]

So is this injected or incribed and do they sacrifice goats or chickens during the ceremony? Our insurance only covers chickens.

[Jeanne]

Looks like it's time to call in those monkey babies again...

[Josh Day]

That's interesting you bring up the topic of pharma freebies, Carrie, cause I have an article here that's dead on with where you're coming from:

http://www.medicationsense.com/articles/jan_apr_07/pharm_free_041507.html

Reading that article then seeing your words, it's clear something positive is going on as a backlash to pharm's influence, at least in some medical schools.

I had a great dermatologist who gave his patients entire boxes of samples so they wouldn't have to pay for prescriptions. The guy was great; he actually talked about diet and food choices as a viable way of treating some acne. And he always explained everything and made it clear nothing was guaranteed to work, laying out several options for treatment. It was stunning, really... never in my life did I trust a doctor as much as that guy or really believe he genuinely cared about my health.

If it were me, Carrie, I don't think I'd give these reps the time of day, like you said, simply not to encourage them. I think it will go a long way in empowering trust and respect for you in your patients.

Not to hijack the Pentacel article, but you mentioned in another post the free lunches these guys duke out to doctors. I know this happens ALL THE TIME in practices. Could be as simple as a pizza brought to the office with a six pack of Coke, or something as lavish as 100 dollar meal with cocktails and premium tickets to a basketball game.

Do you see a lot of this sort of cajoling in medical school, as well as practices? Would you say many of your fellow medical students are of the same mind as you?

[Kathy]

Ok, let me get this straight.

Serious Adverse Events of Pentacel:

2 cases of encephalopathy
5 deaths - causes: asphyxia due to suffocation, head trauma, SIDS and neuroblastoma.

This out of a small sample of the population. What the hell do they think will happen when they start shooting up millions of our children?

This is crazy ...

[Sargent L. Goodchild, Jr.]

Pandorasboxacel would have been a more fitting name.

[Not an MD]

My questions are:
1. How many American babies are going to die from the ever elusive and mysterious "SIDS", due to this new combo whammy to the immune system?
2. How many babies died during the pre-licensure testing?
3. How many temporally connected baby deaths (in previously healthy infants) is it going to take before anyone at the FDA or CDC considers withdrawing this new vaccine?
4. Does anyone at all at the FDA or CDC ever even think about that (question #3), or do they just issue blanket denials across the board about the very obvious potential causal connection between a vaccine and death of an infant?

[Carrie]

This is actually kind of funny...in a I-want-to-give-them-the-finger sort of way. Oh, and I just noticed the baby is doing it for me. I bet Pentacel costs a fortune too (both for the clinics and for the parents). Thankfully, it is still possible to order individual vaccines, it's a bit more work, but some docs are happy to do it. I have stuff to answer on another post.

Actually, this is a good time to ask you something. There is one dilemma I am having and I'd like your thoughts on it. Pharma companies come by clinics and give out samples for free. Of course, they are samples for the most expensive and ridiculous drugs, but "free" samples none-the-less (there are not 100% free because people are paying for them through other methods, that's another discussion altogether). I have seen some mentors accept the drugs and "humor" the reps. They then offer the samples to their patients as help. Sort of like, "Here , I actually have a cream that helps that rash. Don't buy it when you run out though, I'll write you a script for something cheaper and just as effective".

What are your thoughts on this? I sort of like it. But I also like not giving them the pleasure of accepting it. I'm on the fence.

Ps. You don't have to call me Dr. Carrie. For one, I'm not a doc quite yet. For two, I'm not one of those people who likes being referred to as doctor outside of work. At the clinic, fine, but outside of that, I am just another regular person. I don't have doctor on my credit card or anything. I always sort of snorted at those people who were like, "It's DOCTOR Carrie, sheesh". Again, this may all change in 20 years, but for now, Carrie's just fine.

[Kathy]

WTF? Isn't anyone listening? We don't need less injections and more combos ... OMG, this is so frightening. Love the picture of the baby. And what parent would put their child in a clinical trial for this? There were 5000 of them? Should be considered child abuse with the information we currently have on the dangers of multiple vaccines at one time ... I'm scared to be an American. WE HAVE TO KEEP SCREAMING.

[Carrie, come back!]

Well, there goes Dr. Carrie.... (wink)

Kim