….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.