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January 13, 2009

Dr. Paul Offit: Fox in a Henhouse, the ACIP Years (1998-2003)

Doc with vaccine and cashBy J.B. Handley http://www.ageofautism.com/2009/01/dr-paul-offit-fox-in-a-henhouse-the-acip-years-1998-2003.html

"The screaming started four hours after 8-month-old Chaise Irons received a vaccination against rotavirus, recommended in June 1998 by the Centers for Disease Control and Prevention for every infant to prevent serious diarrhea. Within a day he was vomiting and eliminating blood. Doctors performed emergency surgery, saving him by repairing his intestines, which were folding in on one another. A doctor later figured out the vaccine caused Chaise's problem. In October 1999, after 15 reports of such incidents, the CDC withdrew its recommendation for the vaccination -- not because of the problem, the agency claims, but because bad publicity might give vaccines in general a bad name. But a four-month investigation by United Press International found a pattern of serious problems linked to vaccines recommended by the CDC -- and a web of close ties between the agency and the companies that make vaccines."

Mark Benjamin, United Press International, UPI Investigates: The Vaccine Conflict

There are few parents of young children today who remember the disastrous introduction of the first Rotavirus vaccine in June, 1998 and its withdrawal from the market due to adverse events only 13 months later. Of course, the parents of children who experienced severe bowel intussusception, like the child described in UPI's investigative piece quoted above,  remember it all too well. 
The Rotashield introduction and withdrawal was such a fiasco it triggered a Congressional investigation, and a blistering report from the Committee on Government Reform which was released on August 21, 2000 and titled, Conflicts in Vaccine Policy (HERE).
And who would you guess was at the center of the Congressional report's criticism? You guessed it: Dr. Paul Offit.

 People often ask me how the Centers for Disease Control (CDC) went from recommending 10 vaccines for children in the mid-1980s to the bursting-at-the-seams 36 vaccine schedule of today. My answer, which always surprises people, is a four-letter acronym: ACIP.
ACIP? Most people have never heard of it, the Advisory Committee on Immunization Practices. Locked away inside a single page on the CDC website, the ACIP is described as:
"15 experts in fields associated with immunization who have been selected by the Secretary of the U.S. Department of Health and Human Services to provide advice and guidance to the Secretary, the Assistant Secretary for Health, and the Centers for Disease Control and Prevention (CDC) on the control of vaccine-preventable diseases. The Committee develops written recommendations for the routine administration of vaccines to children and adults in the civilian population; recommendations include age for vaccine administration number of doses and dosing interval, and precautions and contraindications. The ACIP is the only entity in the federal government that makes such recommendations. [emphasis added]."
The ACIP is a remarkably powerful committee of appointees. Let's say you're Merck, a giant pharmaceutical company with vaccines as a primary business line. And, let's say you have invested several hundred million dollars in developing a vaccine. Just for fun, let's imagine the vaccine you have developed is for Rotavirus. Let's say you would like to sell your vaccine to as many people as possible.
Well, if you're Merck, and if you want to sell your new Rotavirus to as many people as possible, you can pass through one door and one door only: the ACIP. If the ACIP approves your vaccine, you can write your ticket. If the ACIP denies your vaccine? Zero. As Congress' report notes:
"The recommendation [by the ACIP] for routine use of a vaccine is tantamount to a Federal mandate for vaccine use."
It's almost hard to comprehend the amount of pressure pharma would be under to "manage" the ACIP and give their vaccines the best possible chance for approval – there are literally billions of dollars at stake for a single vaccine.
Enter Dr. Paul Offit. With Merck's funding and support, he filed a patent for a Merck-sponsored Rotavirus vaccine on December 9, 1994. Four years later, as his own vaccine was going through trials and no Rotavirus vaccines were YET on the U.S. vaccine schedule, Offit was appointed to the ACIP as a voting member of the committee.
Of course, Offit was well aware that a competing vaccine for Rotavirus made by Wyeth was years ahead of his own vaccine and preparing for a presentation to the ACIP in the near future. In fact, he joined the ACIP only three weeks before the committee voted to approve Wyeth's Rotashield vaccine for the Vaccines for Children program (Offit voted "yes."). What's so bad about voting for another company's vaccine for Rotavirus vaccine when you are developing a competing product? Congress explains:
"Members of the ACIP are allowed to vote on a recommendation for one company's vaccine even if they have financial ties to a competing firm developing a similar vaccine.  For example, in the case of the rotavirus vaccine, the vaccine before the advisory committee was developed by Wyeth-Lederle. However, Merck and SmithKline29 Beecham had rotavirus vaccines under development. A recommendation for Wyeth- Lederle's vaccine would help pave the way for future recommendations for the products of Merck and SmithKline-Beecham. While ACIP members with ties to Wyeth-Lederle were not allowed to vote on recommendations for the rotavirus vaccine, those with ties to Merck and SmithKline-Beecham were allowed to vote.
This stands in stark contrast to the policies of the FDA. In discussions with FDA staff on this specific issue they informed the Committee staff that when the VRBPAC is deliberating the licensure of a vaccine, a company is considered affected [an affected company is one with a direct interest] if they are direct competitors of the manufacturer of the vaccine being considered. They further clarified that that this policy was in place because of the competing interest of the affected company and not because of concerns about the release of proprietary information."
Dr. Paul Offit joined the ACIP three weeks before they voted on a Rotavirus vaccine manufactured by Wyeth to be added to the vaccine schedule. He held a patent on a competing vaccine. 
It's almost incomprehensible, and certainly shows the worst of how pharma games the US Vaccine system. It's hard to believe, but this story actually gets worse.
As we know from above, this initial vaccine that Paul Offit voted to approve was pulled from the market one short year later because of the level of adverse events affecting children. From the report:
"A product was placed on the market that had to be withdrawn within one year because it was injuring the children it was meant to protect."
Perhaps worse, and even more shocking, was the timing of the ACIP vote to approve Rotashield:
"A particularly troubling aspect of the deliberations on the 'RotaShield' vaccine is the sequence of events. The ACIP Committee voted to recommend universal vaccinations of infants before the FDA licensure of the vaccine. Officials of the CDC acknowledged that they knew of no other instance where this has happened."

Wait a minute. They approved the vaccine for universal use in kids before the FDA licensed the product? Why, that stands in rather marked contrast to the reassuring words of Dr. Renee Jenkins, President of the American Academy of Pediatrics:
"The vaccine schedule undergoes vigorous scientific and evidence-based review each year…The vaccine schedule has evolved over the past 50 years based on scientific evidence."
It appears Paul Offit joined the ACIP to ensure he could influence the approval of the Rotavirus vaccine, from which he would later benefit greatly when his own version of rotavirus vaccine was approved. Not surprisingly, Paul Offit voted yes on every action he could relating to the approval of Wyeth's vaccine. But, when the vaccine was being pulled from the market, Offit abstained:
"Dr. Offit began his tenure on ACIP in October of 1998. Out of four votes pertaining to the ACIP's rotavirus statement, he voted yes three times, including voting for the inclusion of the rotavirus vaccine in the VFC program. Dr. Offit abstained from voting on the ACIP's rescission of the recommendation of the rotavirus vaccine for routine use. He stated at the meeting, 'I'm not conflicted with Wyeth, but because I consult with Merck on the development of rotavirus vaccine, I would still prefer to abstain because it creates a perception of conflict.'"
Approve it? "Yes." Approve it? "Hell yes!" Approve it? "Absolutely." It's hurting a bunch of kids, we need to pull it! "Umm….I have a conflict, gotta go."
On February 23, 2006 the ACIP voted to add Paul Offit's vaccine, Rotateq, to the U.S. Immunization schedule. As we all know, Dr. Offit has conceded this vaccine "made him rich." An analyst for Merck notes, "At a cost of $187.50 for the three-dose series, RotaTeq is one of the most expensive vaccines to date; by 2009, the company forecasts that the vaccine could bring in as much as $500 million in annual revenue."
In May 2008, it was reported that, "Later in 2007, the Centers for Disease Control and Prevention reported that there were 117 confirmed cases of intussusception among recipients of Rotateq between March 2006 and June 2007."

Also, in 2008 it was reported that, "The U.S. Food and Drug Administration approved an update to the product label for Merck & Co.'s Rotateq vaccine to include the report of a death of a recipient due to an intestinal obstruction."

In 2008, Medical Science Monitor published a study critical of Paul Offit's vaccine (HERE).
It stated: "This study found that, after a significant decline in intussusception adverse events entered into VAERS after the withdrawal of RotaShield, the previous rotavirus vaccine, a significant, rapid increase in intussusception adverse-event reports was observed after the licensing of RotaTeq, the current rotavirus vaccine, on February 3, 2006… From February 3, 2006 through July 31, 2007, a total of 160 (of the 165 reported) intussusception and 11 (of the 16 reported) Kawasaki disease adverse event reports were identified when RotaTeq was administered or co-administered with other vaccines. Time-trend analyses showed that there were significant increases in the total number of intussusception and Kawasaki disease adverse events entered into VAERS in comparison to previous years."
And the study concluded:
"Based on the preceding realities, it would seem that the ACIP recommendations for the universal use of RotaTeq were, at best, premature and unwarranted. It is important that healthcare providers continue to report adverse events that occur following RotaTeq vaccine so that more information may be gleaned about its safety profi le, and those patients that may have experienced an adverse effect of RotaTeq vaccination should be advised that they may be eligible for compensation from the no-fault National Vaccine Injury Compensation Program (NVICP).
The acceptance of RotaTeq vaccination for the US market may be significantly limited by its apparent lack of economic savings, and given the fact that it may alter disease patterns of intussusception/ Kawasaki disease, so that they occur with greater frequency among segments of the population that previously had only limited experience with such conditions. Moreover, if the serious adverse events being reported following vaccination with RotaTeq are indeed vaccine related, then, like the previous rotavirus RotaShield, RotaTeq should be immediately withdrawn from the US market."

As of January 2009, Rotateq remains on the market.

J.B. Handley is co-founder of Generation Rescue and a contributor to Age of Autism.


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Look at this cr*p

Vaccine inventor gets death threats

I don't have an account there or I'd comment.

Thanks, J.B., for another revealing article. Note that there's now an autism mom on ACIP who obviously is in utter denial.

If only this information was replicated in mainstream media... but instead the print journalists are whining online about how they've made themselves obsolete. Ironic, eh?

Thank you J.B. This must be hard to write about as it is shocking to read. I had no idea of the depths of Offit's maneuverings. The comparison to Madoff is obvious but I have a feeling Madoff wouldn't have had the stomach for what Offit perpetrated.

No, as far as sociopathic caste, Offit seems more a cross between Dahmer and Goebbels. Goebbels was also a flop as a writer. Maybe the Dahmer analogy is a bit loose but I can't shake it. I have the impression of a total lack of empathy, a limitless capacity for lying and gore and especially those stories about Dahmer's fast talking police out of saving one of Dahmer's victims who almost got away. Think of all the children who could have gotten away if it hadn't been for Offit's endlessly gabbling mouth?

Your article really made it hit home that the CDC, ACIP and other compromised regulatory agencies have been highly practiced in specifically deflecting and suppressing adverse event scenarios related to vaccines for a long time. When they hear about the prevalence of a rare disorder going up, I'm sure the first thing they think is, "Oh, no, it must be that new vax batch".

I just learned Dr. Proffit will be a guest on a local radio talk show tonight (Dom Giordano, WPHT 1210 AM, 6:00 PM for anyone in the Philly area who can stomach it). I just emailed this article to Dom. Proffit will be talking about chicken pox parties. Great, we know how that can be portrayed to make us all look like a bunch of crazies.

Back in the eighties when my son was young, we had our own version of the chicken pox party. We called it daycare. You dropped your kid off, next thing you know you got a phone call to come pick him up. A few days of oatmeal baths, maybe a low-grade fever, and yes, we knew better than to give aspirin. End result was a lifetime of immunity.

Maybe we need to be working on getting some people with brains and hearts onto ACIP.
I've often thought that a requirement for appointment to the ACIP should be undergoing the first two years of the current "recomended" infant vaccine schedule scaled-up to the appointee's body size according to the weight of the smallest infants included in the "recommendations."

Then, of course, before voting to recommend any new vaccine, each panel member should also take the three (or whatever "recommended" number of boosters) doses of the new vaccine scaled-up as well.

I read the article in the NYT about Pauly PrOffit. It was nauseating. This information here, and the congressional reprimand to Pauly PrOffit needs to go to a competing newspaper. The public is getting too much of one side of the argument, and I think it's time we start exposing this slime and letting people see just how reprehensible and money grubbing he is.

JB, again, right on the money. Thank you, yet again, for everything you do to help our children.

Just trying to get these facts straight: RotaShield is withdrawn after 15 reported cases of intussusception. On the other hand, Rotateq has had 160 reported cases of intussusception and 1 death and it is still on the market?!!?

This is horrific! I don't understand how this can continue.

Thank you JB. Keep laying it out in black and white. The American public needs to be made aware.


JB, invaluable reporting again, and again, and again...

Is anyone making sure that all this info gets distributed to Tom Daschle, the soon to be secretary Health and Human Services, the entire Obama cabinet, all the members of Congress and the Senate and whoever else may need to see it?

When we see any information on most mass media about vaccines and autism the only view shown in Offit's. Can we get this info to decent people within NPR, NYTimes, etc. Are there any decent reporters at NPR, NYTimes? How can we make sure that reporting by JB's and others reaches as many people as possible? I'd hate to think that only us, the directly affected, and the vaccine complex crisis control team reads this info.

By the way, since you at the vaccine industrial complex are obviously reading these columns: Are any decent souls in there? How can you be a part of this? Remember the volunteer jewish guards on nazi concentration camps? Look in the mirror because that's you, people, that's you, and you don't even do it to save your life, you just do it for the damn money.

J.B. I LOVE the way you're digging through Dr Offit's dirty laundry. Keep it up. In this case, truth is stranger than fiction. I didn't realize the ACIP had such close ties to political appointees. Why aren't all the stakeholders(parents) involved in this process.

You have definitely refined "The Art of War."

I believe the "Art of War" is a must read for any parent with an Autistic child.

Thank you!

Great research here. What do we know about how rich Rotateq made Offit?
The NYT today has a piece on Offit that is truly stomach-turning. Just a shoddy piece of journalism -- bad research, lazy reporting. I hope you'll cover it today.