Monday, September 9, 2013

HPV Vaccines And Government Agencies: How Valuable Is ‘Expert’ Advice?


HPV Vaccines And Government Agencies: 

How Valuable Is ‘Expert’ Advice?

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?

1.   Professor Dagan, why are fainting, deaths, convulsions and fits ‘expected’ during the week following HPV vaccinations if they are not linked to the vaccine?
2.    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?
3.    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?
4.    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?
5.     Professor Dagan, are there any other ‘expected’ adverse events we should look for in the weeks following HPV vaccinations?
6.    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?
7.     Professor Dagan, why is it necessary to prepare in advance for adverse events if these ‘anticipated’ events are not linked to the vaccine?
8.    Has Israel had to prepare in advance for adverse events after other vaccines we are currently using?
9.    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?
10.    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?

[3] Conflict of Interest Disclosure for article published in Pediatric Infectious Disease Journal
[4] Conflict of Interest Disclosure for article published in BioMed Central

An Indian parliamentary committee has recommended legal action against a major US-based NGO that it accuses of violating ethical standards and national law during a study to assess the possibility of launching a cervical cancer vaccination programme in the country.
The Parliamentary Standing Committee on Health and Family Welfare said that the Program for Appropriate Technology in Health (PATH), a non-profit organization based in Seattle, Washington, and several Indian institutions, failed to follow proper procedures, adequately monitor events or obtain informed consent from all participants.
It called the field test of two human papilloma virus (HPV) vaccines, stopped after seven vaccinated children died, “very intriguing and fishy”, and asserted, without evidence, that the goal was to generate profits for the pharmaceutical industry.
The charges were firmly rebutted by PATH, with Vivien Tsu, the director of its cervical-cancer prevention project, arguing that the report is “inaccurate in many details and incorrectly implies violations of approved practices”. “PATH is committed to meeting the highest scientific, ethical, and legal standards in our work,” she says.
After breast cancer, cervical cancer caused by HPV is the second most common cancer in women worldwide, with around 500,000 new cases and some 250,000 deaths each year — including an estimated 134,000 new cases and 73,000 deaths in India.
The first HPV vaccine, Gardasil, was approved by the US Food and Drug Administration (FDA) in 2006. Two years later, India approved that drug, which is made by Merck, based in Whitehouse Station, New Jersey, as well as Cervarix, another HPV vaccine, made by GlaxoSmithKline, based in London. Both vaccines had been approved for use by the US Food and Drug Administration before the PATH project began in 2009. The study, which used donations of these vaccines and was funded by the Bill and Melinda Gates Foundation, aimed to gather evidence as to how an HPV vaccine might best be widely introduced within the Indian health-care system.
It involved vaccinating 13,000 girls aged 10–14 in the state of Andhra Pradesh with Gardasil and 10,000 with Cervarix in Gujarat, and analysed, for example, how to raise community awareness of HPV, and whether delivering vaccines was best achieved at schools or in health centres.
The study was initially intended to run until 2011, but the Indian government halted the trials in March 2010 after activist groups opposed to the introduction of the vaccine in India alleged safety and ethical violations following the death of seven girls enrolled in the study. An internal government inquiry concluded in 2011 that the deaths were unrelated to the vaccination and that no ethical norms had been infringed.
But the standing committee’s report to the Indian parliament, released on 30 August, maintains that the study violated ethical norms and India’s laws and regulations. As well as PATH, the state governments of Andhra Pradesh and Gujarat and the Indian Council of Medical Research (ICMR) were also singled out for criticism.
The report argues that the study should have fallen under clinical-trials legislation despite its designation as a demonstration project, that informed consent was not properly obtained from all study participants — many of whom were illiterate — and that adverse events were not adequately monitored or reported.
Tsu says that the study, whose primary goal was to determine how many girls were vaccinated, was in no way a clinical trial and that no clinical outcomes were measured — the project had been delayed to await the vaccines’ approval in India in 2008, she adds. Proper procedures for seeking informed consent and tracking adverse events were also used, she says. In a statement on its website, PATH said: “We strongly disagree with the findings, conclusions and tone of the released report and its disregard of the evidence and facts.”
PATH has similar research programmes in Vietnam, Uganda and Peru as part of a project — begun in 2006 with a US$27.8-million grant from the Bill and Melinda Gates Foundation — that aimed to provide poorer countries with practical data on the feasibility and acceptability of introducing the vaccine, notes Tsu.
This year, the GAVI Alliance, a multibillion-dollar public–private partnership that funds and delivers vaccines to developing countries, began introducing HPV vaccines in eight African countries, and aims to vaccinate 30 million girls in 40 nations by 2020. PATH’s demonstration projects in Peru and Uganda helped to launch national HPV immunization programmes and contributed to the GAVI Alliance’s decision to subsidize HPV vaccines for the world’s poorest countries.

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