Sanofi Pasteur Wants Liability Protection for Vaccinating Pregnant Women

Managing Editor's Note:  Kelli Ann and many other Age of Autism readers listened into the 2nd National Stakeholders Meeting on vaccines today. Thanks to everyone who has been commenting and to Kelli Ann for this teaser of much more to come.  Dr. Stanley Plotkin has developed a number of vaccines and worked with Dr. Offit on RotaTeq (HERE.)

By Kelli Ann Davis

Today, during the Institute of Medicine’s (IOM) 2nd National Stakeholder Meeting on the Review of Priorities in the National Vaccine Plan, Stanley Plotkin, Executive Advisor to the CEO of Sanofi Pasteur and Emeritus Professor of Pediatrics at the University of Pennsylvania made a startling revelation: Sanofi Pasteur is lobbying members of the Senate for liability protection.

According to Plotkin, Sanofi Pasteur is concerned about the “legal issue of vaccinating while pregnant” and feels it is “important to keep non-negligence issues” out of the tort system; he stated, “it needs to be addressed” and then went on to say, “I don’t know how it should be done but it needs to be addressed considering what’s happening recently.”

He continued with a suggestion that a “commission” could make an “assessment of the benefit and risks” and “determine this” while stressing that we “have to decide.”

Earlier in the morning, before his mention of Sanofi Pasteur's current lobbying efforts, he stated “there are many vaccine targets left” and “we haven’t exhausted the need for new vaccines.”

Indeed. 

More on the events leading up to this meeting and details on a future “stakeholder’s meeting” due to convene in January 2009 later.

Kelli Ann Davis is the D.C. Political Liaison for Generation Rescue.

Comments

[Twyla]

I totally agree with your 4:11 comment, Jack, and your perspective is interesting.

[Jack]

Twyla,

If I had it to do over I would revise that last paragraph. Vaccines do have their place and actually I've dedicated my career to developing and manufacturing them when I could have been doing a lot more lucrative things (Joe the Vaccine Maker doesn't do as well as Joe the Plumber apparently) because I thought they were good things.

I just think what is missing is a true risk-benefit anaylsis. Facing small-pox maybe 1 in 5,000 is acceptable. Facing chicken pox it is not. Personal risk factors (on either side of the equation) change things too. Injection of 3 million infants should be reserved for the most desparate of situations.

I'm just feeling pessimistic about our capacity to make catastrophic mistakes despite the best intentions, which we'd be lucky to get, because of knowledge gaps.

Increased hospitalization due to pneumonia because of new more virulent strains taking the place of previous common ones after the introduction of Prevnar in Scotland are a prime example of this.

[Tanners Dad]

I managed to get in a plug for Age of Autism as the last word. I spoke about this article on the Mancow Show this morning. I tried to create some real word of mouth... When 4 million people go ask their pregnant friend or relative "have you thought about that flu shot and what it could do to the baby." We hopefully have started a mainstream discussion...

Mancow Show Notes Autism Vaccines Recovery and Causecast http://www.causecast.org/member/tanners-dad/blog_posts/449

[Twyla]

Jack -
One of the problems with studies is they tend to look for one cause. And, as Dr. Bernarding Healy said, "vaccine experts tend to look at the population as a whole, not at individual patients. And population studies are not granular enough to detect individual metabolic, genetic, or immunological variation that might make some children under certain circumstances susceptible to neurological complications after vaccination." http://health.usnews.com/articles/health/brain-and-behavior/2008/04/10/fighting-the-autism-vaccine-war.html

From Sharyl Attkisson's interview with Dr. Healy at www.cbsnews.com/stories/2008/05/12/cbsnews_investigates/main4086809.shtml

"But public health officials have been saying they know, they've been implying to the public there's enough evidence and they know it's not causal," Attkisson said.

"I think you can't say that," Healy said. "You can't say that."

Healy goes on to say public health officials have intentionally avoided researching whether subsets of children are “susceptible” to vaccine side effects - afraid the answer will scare the public.

"You're saying that public health officials have turned their back on a viable area of research largely because they're afraid of what might be found?" Attkisson asked.

Healy said: "There is a completely expressed concern that they don't want to pursue a hypothesis because that hypothesis could be damaging to the public health community at large by scaring people. "First of all," Healy said, "I think the public’s smarter than that. The public values vaccines. But more importantly, I don’t think you should ever turn your back on any scientific hypothesis because you’re afraid of what it might show."

As an example, Healy points to the existing vaccine court claims.

CBS News has learned the government has paid more than 1,300 brain injury claims in vaccine court since 1988, but is not studying those cases or tracking how many of them resulted in autism.

The branch of the government that handles vaccine court told CBS News: “Some children who have been compensated for vaccine injuries... may ultimately end up with autism or autistic symptoms, but we do not track cases on this basis.”

"What we’re seeing in the bulk of the population: vaccines are safe," said Healy. "But there may be this susceptible group. The fact that there is concern, that you don’t want to know that susceptible group is a real disappointment to me. If you know that susceptible group, you can save those children. If you turn your back on the notion that there is a susceptible group... what can I say?"

****

Although, as you say, there may be no way to predict in advance a small number of adverse reactions to a new vaccine, those adverse reactions should be studied when they occur. There is so much fear of recognizing problems that problems are not even addressed, or are addressed incredibly slowly (such as changing from DPT to DTaP or from live polio virus or removing thimerosal from some but not all vaccines with no recall of existing supplies).

It is not hard to find the injured children. Thousands of injuries have been reported to VAERS. Thousands of families have filed claims under the Autism Omnibus procedings. Parents such as Lyn Redwood have said they were shocked to find that the government was not interested in their children's stories of injury and (in some cases) recovery.

I'm not quite sure what you mean in your last paragraph, Jack. Are you saying that we should not have any vaccines? I do believe that some vaccines have more benefit than risk. I agree that there is a lot of arrogance involved, and that we do not fully understand the immune system. An infectious disease specialist I happened to speak with a few weeks ago said: "There is so much that we do not understand about the immune system."

Regarding other factors such as overuse of antibiotics and tylenol, I agree that these may be contributing factors. However, those factors also existed back in the 1970's and 1980's when the autism rate was quite low. The things that have really changed during the past two decades are the number of vaccines and the amount of toxins such as mercury in our environment. I believe that, while autism may have many causes, vaccines are a primary factor, and one that can be controlled.

[anonymous antivaccinationist]

@Patrick,

[[[They want to change how adverse reactions are handled when they occur in clinical trials.]]]

They are already not required to report it. Title 21 in the CFR:

Subpart D sec. 600.800:

(e) Postmarketing studies. (1) Licensed manufacturers are not required to submit a 15-day Alert report under paragraph (c) of this section for an adverse experience obtained from a postmarketing clinical study (whether or not conducted under a biological investigational new drug application) unless the licensed manufacturer concludes that there is a reasonable possibility that the product caused the adverse experience.

Then protocol for waiver:

§ 600.90 - Waivers

(a) A licensed manufacturer may ask the Food and Drug Administration to waive under this section any requirement that applies to the licensed manufacturer under §§600.80 and 600.81. A waiver request under this section is required to be submitted with supporting documentation. The waiver request is required to contain one of the following:

(1) An explanation why the licensed manufacturer’s compliance with the requirement is unnecessary or cannot be achieved,

(2) A description of an alternative submission that satisfies the purpose of the requirement, or

(3) Other information justifying a waiver.

(b) FDA may grant a waiver if it finds one of the following:

(1) The licensed manufacturer’s compliance with the requirement is unnecessary or cannot be achieved,

(2) The licensed manufacturer’s alternative submission satisfies the requirement, or

(3) The licensed manufacturer’s submission otherwise justifies a waiver.

Feeling warm and fuzzy?

AA

[anonymous antivaccinationist]

@garbo:

[[[Implicit in their pleas for liability protection is a threat to withdraw from the market, leaving the government with no vaccines at all. I believe this is an empty threat as they would be leaving billions of dollars on the table when they walked away.]]]

Of course. This is with hopes that someone covering the meeting in their camp will pick it up and run with it. This will instill hysteria and fear. Next, an envelope with white powder will be delivered to some medical clinic and we'll all be herded into the community center for
Anthrax vaccines and Cipro. People will flock to the pharmacy to get Cipro just in case, and Bayer's stock will increase 15 fold.

AA

[Jack]

There have been some incredibly stupid things done (Thimerosal, HepB on day one, etc). And a shocking lack of consideration for the patient and oath of first do no harm.

But I think the elephant in the room isn't that our vaccine schedule is causing autism, but that there would be no way to see something similar moving forward.

You're trying to detect maybe 1 in 1,000 (I think there are multiple ways autism can happen) extemely complicated adverse events that often happen (or at least diagnosis of it) after a long course of time and potentially in conjuntion with other issues, such as over-prescription of antibiotics, use of tylenol, etc. How can you possibly design a clinical trial to detect that, especially when you don't know what you'd be looking for?

Some stupid things could be changed. Thimerosal removed. The schedule changed. No combo vaccines.

But when it comes to developing a new vaccine I'm not sure how much safer you can be. Who is to say whether a chosen SARS antigen might be similar to some native protein in 1 in 5,000 people =that sets off an auto-immune attach similar to MS or ALS. There is no way to know that and no amount of money or effort would detect it.

The great folly of our society was to think we were smart enough to take control of the way our immune system works and thereby defeat disease. While greed has been a factor, the primary error was human arrogance. We should have just been washing our hand thoroughly this whole time.

[Twyla]

Jack, it sounds like you are saying that the only way that companies can make money off of vaccines is if they are allowed to make totally unsafe vaccines with no repercussions. I find that hard to believe.

[Twyla]

Jack said, "I don't think we can reasonably say we are pro-safe vaccine. I don't believe we can ever have that for all people."

I am certainly for safER vaccines. I am for the makers of vaccines producing the very safest vaccines possible. I am for the study of adverse reactions to understand better what causes those reactions, who is most vulnerable, and how to best treat those reactions.

Yes, it is true that vaccines most likely cannot be made safe for absolutely everyone. But if there were 1 in a million serious adverse reactions, or even one in 100,000, that would be so much better than the current situation where at least 1 in 150 children have autism and kids have increasing rates of asthma, diabetes, ADHD, severe allergies...

The fact that vaccines cannot be perfect is no excuse for not making them as safe as possible, no excuse for sweeping problems under the rug. Cars are not perfect either, but we continue to develope technology etc. to make them as safe as possible.

And decisions such as giving hepatitis B vaccines containing thimerosal to all newborns on the day of birth are just insane. There has to be better weighing of risks and benefits.

[sdtech]

Karenatlanta:

Yes, organized inhumanity comes to mind when searching for answers. Just how do we explain the lack of vaccine safety for children in our current society? Profits versus First Do No Harm!?

[sdtech]

Kelli:

Thank you. This is important regarding pharmaceutical concerns on possible causes of Autism.

On David Kirby’s HuffingtonPost at http://www.huffingtonpost.com/david-kirby/new-study---mitochondrial_b_147030.html , Spectrum Dad referred to fetus exposure data for the flu vaccine Thimerosal mercury. See
http://www.cdc.gov/flu/professionals/vaccination/pdf/vaccinetrend.pdf

This is really troubling. Looking at the ten year period from 1997 to 2006, this data extrapolates to an average of 11.47 percent of pregnant women receiving a flu shot. Using a figure of 4 million children born each year gives an estimated 458,800 fetuses exposed to Thimerosal. Then using the CDC Autism rate from 2002 of 1/150 gives an estimated 26,667 children diagnosed with Autism annually. And this number of children with Autism calculates out to 5.81 % of the pregnant women exposed annually to “standard Thimerosal content” of 25 micrograms of mercury levels from the shot. This amount is with the use of the multi-dose vial. See http://www.vaccineshoppe.com/image.cfm?image_type=product_pdf&pi=flu ).

And the CDC message to pregnant women right now is “Is it safe for pregnant women to receive an influenza vaccine that contains thimerosal? Yes... the benefits of influenza vaccine with reduced or standard thimerosal content outweighs the theoretical risk, if any, of thimerosal.” See http://www.cdc.gov/FLU/ABOUT/QA/thimerosal.htm , September 23, 2008.

Again, just what part of neurotoxin doesn’t the CDC get?

This CDC vaccine trend data seems to only reinforce the hypothesis that the flu shot with Thimerosal, given to pregnant women, results in a significant contribution to Autism in children.

[Julie Swenson]

Chris, yep, that's me over on Baby Center...I don't even read those boards anymore--too depressing.

[Jack]

Well, I'm certainly not trying to defend them. There has certainly been too much abuse, criminal cover-up and out-right stupidity for that.

But I don't think it is a case of them threatening to quit developing vaccines in the "we're taking our ball and going home" type of way. I think it is just an inevitable outcome. If one of the big pharma's annouces that they are going to invest millions into developing a product with no assured market and in the face of tremendous potential liability the stock would crash. Shareholders would revolt, CEOs would be ousted. The decision wouldn't belong to the pharma executives, it would belong to Wall Street.

IF (all caps intentional) these guys care about developing new drugs because they think they are good for the world, they would still say the things they said in the meeting yesterday.

What's the answer, I don't know. Lots of zinc and vitamin C. Less processed foods and pesticides maybe...and freedom of choice when it comes to your own family's medical care.

[Gatogorra]

Jack-- well, here's one thing I can think of which Hillary Clinton contributed. She suggested this year that a law be passed forcing vaccine manufacturers to give one year's notice before abandoning production of any product on the market. That would be about enough time for some pharma start-up to take over production. Smaller companies might not whine as much if ordered to do R&D on safer products and won't have the clout to make threats if made liable to ensure product safety.

Considering that Clinton sent people to Rep. Maloney's briefing on the hill, maybe she's rethinking her past enthusiasm for hypervaccination. Who knows but it would be a clever strategy to hold the "targets" (in this case, pharma) down while legislatively reinstating liability on the industry.

Not that people who no longer vaccinate even care whether vaccine makers cut and run, but it's a potent threat to the rest of the populace. The threat also hinders research on safer products. I'd like to see industry divested of weilding this threat for good.

[biomedmom]

Jack, the executives who feel that way should be forcibly removed and replaced, and the remaining staff should be able to continue - manufacturing only truly necessary vaccines that are free of toxins.

What they have done and continued to do is criminal and no one should ever cave in to a hissy fit on such a crucial scale as this.

If they are going to threaten withholding medicines because they can't continue to damage human beings for profit then they are not the type of people we need in key positions in the pharmaceutical industry. The people and organizations who pander to them have made themselves just as complicit.

[Patrick]

This one bothered me:

They want to change how adverse reactions are handled when they occur in clinical trials.

If they start handleing adverse reactions the way pediatricians handle them we are in trouble (not reporting).

The woman that brought this up stressed the point at least twice during the meeting.

[Jack]

Garbo,

Well, I agree with that my hope for actual informed choice and individualized medicine is hopelessly idealistic.

But I disagree with the second half of this:

"Implicit in their pleas for liability protection is a threat to withdraw from the market, leaving the government with no vaccines at all. I believe this is an empty threat as they would be leaving billions of dollars on the table when they walked away."

I think the threat is real. Without the liability protection and mandates they won't be walking away from billions in profit, just a headache and I think they will. Why spend 100 million dollars and 8 years taking a shot at a SARS vaccine, for instance, in that environment?

I think that is why it is the organizations like the CDC, AAP, etc. that fight us so hard and maintain/orchestrate the cover up. If vaccine development stops because the truth about risks comes out, and we do have some truly serious outbreak the public will see the failure as their's.

[Garbo]

Jack:
"We should stand on pro-informed choice. Pro-freedom of choice. Pro-doctors that investigate the individual and make the recommendation right for them."

I agree that this would be great in an ideal world, but if you listen to what they were talking about in that meeting yesterday, it was basically about marketing and how important it is for the government panels (IOM, CDC, etc.) to make recommendations that encourage people to use these vaccines. Actual informed choice, with actual transparency, without government putting its weighty finger on the scales to tip the balance toward vaccination, would devastate their business model. Implicit in their pleas for liability protection is a threat to withdraw from the market, leaving the government with no vaccines at all. I believe this is an empty threat as they would be leaving billions of dollars on the table when they walked away. But the FDA/CDC/HHS don't seem willing to play that hand of poker. It is far easier for them to portray us as hysterics on the lunatic fringe than it is for them to explain to people that vaccines have certain benefits and certain risks.

[karenatlanta]

Sorry I meant to say an "awful notion".
I am so mad.
This article sums up my feeling about the free pass vaccine makers are given.
As if our babies and toddlers don't matter.
What an inhumane gesture.
How Hitler perverted the course of science
The Nazis' gruesome experiments became an accepted part of German medical research,
http://www.telegraph.co.uk/scienceandtechnology/science/sciencenews/3540339/How-Hitler-perverted-the-course-of-science.html

[Gatogorra]

I love the war imagery in this: "there are many vaccine targets left". Hmm. Guess who's the enemy?

It's all a kind of video war game with cash prizes to these people, isn't it? They even have their little bug-warrior hero avatar identities. If they can go on silencing the victims through clever tort hacking and suppressing independent science, then they can continue playing and imagining that this is all taking place in virtual reality.