By Kelli Ann Davis
“What Would One Want From A National Vaccine Plan? A Predictable Regulatory Environment” – Philip Dormitzer, Novartis
Predictable: v. to state, tell about, or make known in advance, especially on the basis of special knowledge.
On December 1st, the Institutes of Medicine’s (IOM) Committee on Review of Priorities in the National Vaccine Plan held its Second National Stakeholder’s Meeting in Irvine, California; this pivotal IOM Committee has been given "carte blanche" marching orders from the National Vaccine Program Office (NVPO) for developing the National Vaccine Plan. (More detailed information at the end of this post.)
Among the invited attendees were pharmaceutical representatives Philip Dormitzer (Novartis), Edward S. Mocarski, Jr. (MedImmune), and Stanley Plotkin (Sanofi Pasteur). Due to an audio telecast, many of us were able to hear various strategies promoted by these vaccine manufacturers which (more often than not) went virtually unchallenged by government officials; here are some highlights from the meeting:
Strategy 1: Push for Predictability
Dormitzer: When discussing vaccines for the market he states, “We don’t need incentive because it’s already there.” He’d rather have a “predictable regulatory environment” which “while ensuring public safety one has confidence that the vaccine makes it through.” And “communication with the public” is his key to making that happen. But since “we’re not the best advocates because we have a financial incentive” he suggests “government agencies are the advocates” to get the job done.
Strategy 2: Push for Recommendations
This theme came up multiple times throughout the day.
Plotkin: “The second point I want to hammer is the importance of recommendations.” He mentions a prior 2000 IOM Committee (included in his second slide presentation) and states, “The most important external or nonscientific event is the recommendation of the previous IOM panel. Recommendation from committees like this really do get read.” He then goes into some detail about CMV and says, “Until the recommendation came out companies were uninterested because they didn’t think it was important” and as such a “limited number of companies were interested.” But “once the IOM recommendation came out things changed and numerous companies are now interested in CMV/experimental vaccines.”
Later in the afternoon during his second slide presentation, he expands on this subject further. “Lime disease vaccine” is an example “where public health failed. One reason it failed was the lukewarm recommendation from ACIP.” He expounds a bit and then drives home his points: “Public health recommendations are key and they have to be considered” and “Recommendations have to be formulated so the vaccine is used.” For the second time that day, he mentions the importance of the previous IOM recommendation by saying, “the 2000 IOM report was issued” and “experimental vaccines are being produced because of this report.”
Strategy 3: Target an “Orphan Group” and Use Recommendations to Bolster Your Market
When a vaccine is likely to be targeted to a limited number of individuals in the US, it is called an “orphan vaccine”. Generally, the costs of producing orphan vaccines surpass the potential sales. Therefore, few organizations are willing to develop vaccines for rare diseases when they do not expect to recover the development costs.
During Panel One, discussions focus on pregnancy, vaccines and recommendations.
Mocarski: There is a “need to vaccinate young woman/pregnant woman” but unfortunately, “ACOG (American College of Obstetricians and Gynecologists) hasn’t bought into this idea.”
Alas, a few moments later he is reassured by Kathryn Edwards (Vanderbilt University) who replies, “ACOG is interested” and she then goes on to state how parents will blame the vaccines if their children “don’t grow up and go to Harvard -- that it’s somehow attributed to want they got during pregnancy.”
Plotkin: “Pregnant women are an orphan group” and expounds by discussing the “legal issue and public perception issue” and goes on to state, “there has to be a way of including pregnancy into the compensation system.” He provides some background history and declares, “From my experience” the issue “causes lawyers to raise up and say ‘no way.”’ But, he’s not deterred. He continues, “Government can change it by saying ‘we need vaccines for women.’” But, seems ACOG may still be an issue since he goes on to say, “obstetricians are worried about the idea.” He reasons that “passive protection would protect infants” and then goes back to suggesting “NVAC and the IOM need to say ‘this is important and we should be doing this.’”
Strategy 4: Push for Legal Protections
During Panel One, Robin Robinson (DHHS) started discussing influenza in regards to requirements and shared how they “did something different.” They asked the “specific question: could we use the adjuvant from one company to another because that’s not how it’s licensed. After a year, the CDC/NIH/FDA/DOJ/FTC were involved because of the anti trust issue here” and by using these agencies they were able to “waive that.” The motivation was if the “pandemic occurred tomorrow what would we do?” “The issue that was most formable was publication.” He went on to describe how the “companies didn’t want to go that way” and so eventually the work was “published with commentary by HHS.” He discussed “going forward” along with “real partnership” and defined that as “if you participate you get to see data and if you don’t participate you don’t see data.”
Plotkin picked up on the discussion by stating they need to be “innovative in the use of adjuvants.” He discussed “legal issues” and “intellectual property” followed by “anti-trust issues” and used “bio-defense” as an example on why they “tried to organize companies” but the “lawyers said we can’t do that” and so the “legal issues need to be addressed” in order to “stimulate process innovation” because there are “financial and regulatory implications.” He indicated that once an “established vaccine was being made there’s not much incentive to change it.”
Next he discussed liability protection which I wrote about (HERE).
One glimmer of hope from the day long proceedings happened when Ray Strikas (NVPO) went up to the mike and challenged Harry Greenberg (Stanford) by stating, “I disagree with Dr. Greenberg. Benefits and risks are important in regards to the public.”
Earlier, Greenberg gushed, “I love vaccines and anyone would have to be an idiot not to recognize what vaccines have done” followed closely by ”safety and public health perceptions create problems” and “without government intervention a vaccine won’t go forward like it needs to go.”
He responded to the criticism from Strikas by noting that “there is nothing in the document about the benefits and risks” and “I don’t think it goes there.”
Boy, do we have a lot of work to do in changing the course of these discussions.
About the National Vaccine Plan:
The NVPO, part of Department of Health and Human Services (DHHS), is coordinating the update to the 1994 National Vaccine Plan and DHHS agencies and other departments are contributing to the plan with advice from the National Vaccine Advisory Committee (NVAC).
There are many important stakeholders whose input is needed. IOM has been asked to get input from scientific, medical, public health, and private sector experts (meetings are open to the public). NVPO will conduct a separate and extensive process to obtain input from the general public.
The purpose of Stakeholder Meetings will be to: explore topics related to the five major goals of the draft National Vaccine Plan and; react to draft objectives being developed by DHHS agencies.
Overview of the Study Process: Charge to the IOM Committee
1. Review the 1994 National Vaccine Plan and then provide guidance on the development of the update to the plan:
• On March 3, 2008, the IOM’s Meeting 1: Review of Priorities in the National Vaccine Plan took place in Washington, D.C. At this meeting, I learned the National Vaccine Advisory Committee’s (NVAC) Vaccine Safety Working Group (VSWG) was busy working on a “vaccine safety white paper” and after my public comment (HERE). I was able to connect with Ray Strikas of the NVPO. (On April 11, 2008, the “white paper” was discussed in-depth at the NVAC VSWG meeting in Washington, D.C. (HERE).
2. The committee will hold five information-gathering meetings with stakeholders to explore areas of the developing plan and prepare a report about priorities in updated National Vaccine Plan:
• On July 24, 2008, the First National Stakeholder’s Meeting was held in Chicago, Illinois.
• On December 1, 2008, the Second Stakeholder’s Meeting was held in Irvine, California.
Kelli Ann Davis is the D.C. Political Liaison for Generation Rescue.