Government Agencies

By Norma Erickson

Every government in the world has some sort of committee established to provide advice on vaccines and vaccination practices to those who establish vaccination policies. Since the recommendations made by these committees are the first step toward making any vaccine part of public health policy, it is time to take a serious look at the quality of advice being offered by these committees. Just how valuable is it?

Let’s take a recent teleconference held by Israel’s Advisory Committee on Infectious Diseases and Inoculations as a case in point. One of the topics scheduled for discussion at this meeting was the proposed introduction of HPV vaccines into Israel’s school inoculation program targeting 14 year-old girls.[1]

Dr. Ron Dagan[2] is Professor of Pediatrics and Infectious Diseases at the Ben-Gurion University of the Negev in Beer-Sheva, Israel, and Director of the Pediatric Infectious Disease Unit at the Soroka University Medical Center, also in Beer-Sheva. An active researcher and international lecturer, Dr. Dagan’s work focuses on new conjugate vaccines. His expert advice to Israel’s Advisory Committee regarding potential HPV vaccine implementation is as follows (translation provided-emphasis added):

We are dealing with injections, some of which given in 3 [separate] doses, which are delivered to teenage girls. Many side effects are to be expected. During the week following the vaccine delivery of the injections many serious events which are not related to the vaccination are expected: fainting, deaths and convulsions/fits. This needs to be taken into account. Even if it is not rational, if these events happen in class they may damage the general reputation of vaccinations. This is happening all over the world all the time. We have already dealt with a similar issue in relation to the delivery of MMR with TD and Polio and we have accepted the nurse’s proposal to split these between grades 1 and 2. The nurses are suitable to make recommendations to the committee in relation to this issue. In relation to the side effects, we need to be prepared in advance and not simply react after the fact. I propose we consult with the English representatives as to how they’ve gone about this. We must prepare for the delivery of the new vaccine. The nurses need to know they are going about this in the way they are most comfortable with (/have the most control over/familiarity with).

Did anyone participating in this teleconference question Professor Dagan’s expert advice? Did the members of this advisory committee fulfill their obligation to the citizens of Israel by providing the best science-based information available to the Ministry of Health and any others who would be involved in making the decision to target 14 year-old girls for HPV vaccinations, or did they simply accept his statements at face value?

Did Israel’s Advisory Committee on Infectious Diseases and Inoculations ask the following questions?

Professor Dagan, why are fainting, deaths, convulsions and fits ‘expected’ during the week following HPV vaccinations if they are not linked to the vaccine? Professor Dagan, how was the current rate of these events in 14 year-old girls determined? Can you provide the data on these events for the last year? If a girl experiences one of the adverse events you mentioned within a short time after HPV vaccination, why is it not logical to at least consider the possibility of a defective batch or perhaps improper storage? Professor Dagan, should a girl collapse and die in class why would the primary consideration be protecting the general perception and status of HPV vaccinations? Is it not more important to find out what caused the girl’s death? Professor Dagan, are there any other ‘expected’ adverse events we should look for in the weeks following HPV vaccinations? Considering the fact that Israel has no system in place to track adverse events after vaccinations, and most countries only have passive reporting systems in place, why is it ‘irrational’ to assume an adverse event occurring shortly after HPV vaccination would be linked to the vaccine? Professor Dagan, why is it necessary to prepare in advance for adverse events if these ‘anticipated’ events are not linked to the vaccine? Has Israel had to prepare in advance for adverse events after other vaccines we are currently using? Professor Dagan, how can we know in advance that these ‘expected’ events like fainting, deaths, convulsions and fits are not related to HPV vaccines? Should these types of events not be investigated to prove they are not linked to the vaccines so we can inform the public of what actually caused the incidents? Professor Dagan, are you telling us that ‘English representatives’ prepared in advance for anticipated adverse events after Gardasil and/or Cervarix vaccinations?

Since Professor Ron Dagan is an expert he should be able to answer all of these questions and provide scientific documentation to verify his statements without any problem at all. If he is not able to do so, one should question his ‘expert’ status.

Experts and Conflicts of Interest

Was this committee made aware of the fact that in the past 12 months, Professor Dagan[3],[4] has received grants/research support from Berna/Crucell, Binax, GlaxoSmithKline, MedImmune, Merck & Co., Inc., Novartis and Wyeth; consultant fees from Berna/Crucell, GlaxoSmithKline, MedImmune, Merck & Co., Inc., Novartis and Wyeth; and speaker fees from Berna/Crucell, GlaxoSmithKline and Wyeth? Was the committee informed that Dr. Dagan is a shareholder of Protea/NASVAX?

If the committee was informed of these potential conflicts of interest, did they consider the possibility that these facts could have influenced Professor Dagan’s presentation?

If the committee was not informed of these potential conflicts of interest, what are the implications for medical consumers in Israel?

If Israel’s Advisory Committee on Infectious Diseases and Inoculations made recommendations to the Ministry of Health without obtaining satisfactory answers and scientific documentation to the questions above, how can the Ministry of Health be expected to make a sound decision about HPV vaccines in their country?

How can the Ministry of Health in Israel be expected to live up to their obligation to protect the public health if these questions are left unanswered?

Is advice like that given by Professor Dagan similar to that given by other experts regarding HPV vaccines around the world?

If so, how has the vaccination advisory committee in your country responded?