[FAMESystems] DrftRevu_Non-effective Meningococcal Meningitis Vaccination Program &

[Guest guest]

ALL,

Attached is " pdf " files for an in-depth report titled,

" The Non-cost-effective Vaccination Program for Neisseria

Meningitidis, and Other Vaccination-Program Concerns and

Suggestions " .

For those who need a copy of the " doc " file for

publication purposes, please send me an e-mail with

" N-C-E-VPNM " in the subject line and the reason you need

the document in the text.

For those who do not receive attachments, the " .pdf "

version of this article can be found in the

" Documents " section of the the author's web site:

http://www.dr-king.com

today (28 January 2011).

In addition, the rough text of the article (without

the cited tables) follows:

> The Non-cost-effective Vaccination

> Program for Neisseria Meningitidis,

> and Other Vaccination-Program

> Concerns and Suggestions

>

>

> Introduction

>

> In determining whether a given vaccination

>program can be cost-effective, the factors that

>need to be considered are: a) all of the costs of

>the vaccination program, the estimated number

>of disease cases prevented, and c) the estimated

>number of deaths from the disease for which the

>vaccine is claimed to be somewhat protective for

>some period of time.

>

> In general, for a preventive (prophylactic)

>vaccination to be cost-effective: a) the disease

>must be common (endemic) and have a significant

>(>10%) mortality rate in those with a clinical case

>of the disease (e.g., measles in children), the

>vaccine must be highly effective (providing true

>disease protection to more than 90% of those who

>are inoculated for their " lifetime " ), c) the vaccine,

>its administration costs, and its adverse-event costs

>must be sufficiently low so that the projected

>average cost savings from vaccination are

>significantly more than the average disease-case-

>associated costs, and d) the serious adverse

>reactions (death, permanent disability and life-

>threatening events) caused by the vaccine must be

>significantly rarer than those caused by the disease

>before the vaccine approval and the other

>vaccination-associated costs (e.g., emergency room

>visits, hospitalizations and extended

>hospitalizations) must be sufficiently low so that

>their population costs are some small fraction of the

>population administration costs and, collectively,

>are much less than the costs associated with the

>disease in the absence of any effective vaccine.

>

> Unfortunately, the requirement that a vaccination

>program must be truly cost-effective when all of the

>preceding costs are considered is consistently

>ignored.

>

> In the current vaccine approval process, the

>submitter of the application is allowed to: a) make

>unsubstantiated claims of vaccine effectiveness

>based on anti-body titer, ignore the costs of the

>adverse events associated with vaccination, c) make

>unproven claims as to the level of disease protection

>provided and the duration of the protection provided

>by the vaccination series proposed and d), using all

>of the preceding devices, define the cost of any

>vaccination program in a manner that justifies the

>list price proposed by the manufacturer for the

>vaccine.

>

> The Advisory Committee on Immunization

>Practice (ACIP) to the Centers for Disease Control

>and Protection (CDC), apparently acting as a rubber

>stamp for the vaccine makers, simply presumes that

>the projections offered by the approved vaccine's

>manufacturer or the researchers whom they have

>given grants or have otherwise hired are valid and,

>before (in the case of the now-withdrawn Wyeth

>RotaShield® rotavirus vaccine), or soon after,

>approval (in the case of the meningococcal

>meningitis vaccines (Sanofi's Menomune® and

>Menactra®, and Novartis' MenVeo®) and the HPV

>vaccines (Merck's Gardasil® and Glaxo-

>Kline's Cervarix®) simply adds the vaccines to the

>recommended vaccination schedule without any

>long-term study of: a) the in-use performance of the

>vaccine and the delayed-adverse-reaction profile

>for the vaccine.

>

> Then, when the vaccine fails to meet its claimed

>protection period or protection level, rather than

>removing the vaccine from the recommended

>national vaccination program as it should, the CDC,

>through its ACIP, simply adds one or more booster

>doses without regard for the reality that, even if the

>initial vaccination program were cost-effective, the

>addition of any booster clearly renders it much less

>cost-effective or, more often, non-cost-effective.

>

> With the preceding realities in mind, let us

>consider the cost-effectiveness of the original " one

>dose " meningococcal meningitis vaccination

>program for children ages 11- or 12- years old, or

>13 to 18 years of age if they missed the vaccination

>at age 11 or 12, and a second dose to college

>freshman living in dormitories, with the

>understanding that the ACIP has just recommended

>a second dose to all children at age 16 because the

>claimed but unsubstantiated 10-year protection interval

>used to get the vaccines approved has been found to

>be overly optimistic and a equally unsubstantiated

>5-year period of protection is now being claimed.

>

>

> The Realities Concerning the Current

> Meningococcal Meningitis Vaccination

> Program

>

> Given: a) an administered per-dose average cost

>of US$ 150.00 [1]; an annual US-population

>segment needing vaccination of about 4,000,000

>individuals in the year the vaccine was approved

>(January 2005); c) a maximum vaccine in-use

>effectiveness of " 85% " for the diphtheria-toxoid-

>(Menactra) and Diphtheria-CRM197 (MenVeo)-

>conjugated oligosaccharide antigens for the " A " ,

> " C " , " Y " and " W-135 " strains in the current recommended

>vaccines; and d) an average maximum disease 0.67

>strain-prevalence fraction for the covered strains,

>this mass vaccination program: 1) with " 100 % " coverage,

>would prevent less than 57% of the disease cases

>observed annually and 2) would have an annual cost

>of in excess of US$ 600 million per fully dosed

>population segment.

> [1] The cost estimate is derived from a presumed

> US$ 50.00 cost for the administration and

> records keeping associated with each dose and

> the CDC price list for vaccines found at

> http://www.cdc.gov/vaccines/programs/vfc/cdc-vac-price-list.htm

> when visited on 3 January 2011, where the CDC

> per-dose prices for Sanofi's Menactra and

> Novartis' MenVeo were both US$ 79.75 and the

> wholesale prices to the market were US$ 106.49

> and US$ 103.41 respectively (after Sanofi just

> raised its wholesale price from $103.41). At

> retail, per-dose prices of US$140.00 have been

> reported and the overhead cost in many

> physicians' offices exceeds US$50.00. Overall,

> the estimated average per-dose cost of US$

> 150.00 probably underestimates the true per-

> dose costs.

>

> Since this cost estimate does not include the

>second doses for the college students living in

>dormitories, it obviously underestimates the

>maximum costs but it certainly can be used to

>project an annual cost of about US$ 1 billion for

>the ACIP's recent 2nd-dose recommendation.

>

> Given that the number of clinical cases reported

>in 2004, the year before Menactra's approval and the

>CDC's recommendation to add it to the national

>vaccination recommendations, were about 1,360

>and the cases in 2008, when the claimed uptake was

>41.8% of the children between 13 and 18 years of

>age (5 years and 0.418 x ~ 20 million eligible

>children ˜ 8.36 million children inoculated) were

>about 1,170, it would appear that the vaccination

>program " saved " no more than 190 cases (see the

>cases data in Table 1) at an overall 2008 cost of

>about US$ 260 million or about US$ 1.4 million

>dollars per case prevented.

>

> Since about 10% of those diagnosed with a

>clinical case of N. meningitidis succumb (die), the

>cost per death prevented for the " 19 " deaths saved

>would be about US$ 14 million [2].

> [2] Factually, in 2010, the CDC only claimed a

> saving of 9 lives annually (see:

>http://www.fiercepharma.com/story/cdc-panel-backs-additional-vax-doses/2010

-10-28?utm_medium=nl & utm_source=internal)

> (or ~ 90 cases) for the one-dose program, which

> could increase the overall cost for each death

> saved in 2008 to about US$ 30 million.

>

>

> The Dissonance between 2010 Realities and

> Mainstream Media Hype

>

> Late in 2010, prior to the CDC/ACIP

>recommendation for another dose of vaccine, the

>mainstream media made much of an apparent

>outbreak in a Colorado college town.

>

> To hear the media tell it, the outbreak could be

>attributed to the lack of vaccination and everyone,

>including those who had already been vaccinated,

>was encouraged to be vaccinated.

>

> Mass vaccination clinics were held at the

>university and thousands were vaccinated.

>

> However, though the CDC's numbers for disease

>cases in 2010 are tentative and the number of

> " meningococcal meningitis " -associated deaths are

>not available, the current count on notified cases is

>the lowest that has been reported in the last 67 years

>(see Table 2's " Notified Cases " column 1).

>

> How, except to enrich the vaccines' makers and

>the healthcare establishment, does this reality justify

>adding another dose of vaccine?

>

> Obviously, outside of the media's hype and the

>CDC/ACIP recommendations, there is no medical

>cost-effectiveness justification for including another

>dose of any vaccine for meningococcal meningitis

>in the US recommended vaccination [3] program.

> [3] This writer rejects the use of the term

> " immunization " as it applies to any vaccination

> program that does not confer lifetime immunity

> to the diseases for which the vaccine is supposed

> to provide protection, where, the term " lifetime " ,

> means the protection provided by inoculation

> with the vaccine that has been proven to last not

> less than 50 years after the administration of

> one-dose of the vaccine in at least 95% of those

> vaccinated.

>

>

> Program Realities and Recommended Actions

>

> Clearly, this vaccination program is not a cost-

>effective use of the American public's healthcare

>dollars.

>

> Thus, this vaccine should:

> a. Never have been added to the US CDC's

> national vaccination recommendations [4] and

> b. Be immediately deleted from all US mass

> vaccination programs.

> [4] Based on a preliminary assessment, since 1985,

> the CDC has also wrongly added the vaccines

> for hepatitis B, Hib, chickenpox, influenza,

> rotavirus, and human papilloma virus (HPV) to

> the vaccination programs for children even

> though none of the recommended vaccination

> programs using these vaccines is currently

> medically cost-effective.

>

> Further, given the " deaths " data for the period

>from 2000 through 2009, it is not clear that the

>vaccination program has resulted in any significant

>reduction in deaths for a disease that, in the USA is

>rare (< 1.5 in 100,000 individuals annually) and has

>generally been below this level since 1970 and was

>trending below 1 in 100,000 individuals annually

>since 1999 - 6 years before the first conjugated,

>general-use vaccine was approved in 2005.

>

> Thus, this vaccine is but another example of a

>vaccine that was introduced for an already rare

>disease that was naturally waning in the USA

>apparently so that, ignoring the vaccination-related

>deaths and permanent disabilities, any further

>reductions in disease cases could be attributed to the

>vaccination program.

>

> Since the CDC's ACIP has just recommended

>another mass dosing of a meningococcal meningitis

>vaccine for this rare disease at " 16 " years of age,

>the non-cost-effectiveness of this vaccination

>program is even clearer [5].

> [5] See Table 3's footnote 3.

>

> Factually, the vaccines for N. meningitidis are but

>further examples of out-of-control vaccination

>policies where no real regard is given for

>vaccination-program cost-effectiveness other than

>the profits that will accrue to the vaccine maker and

>the healthcare establishment.

>

> From the CDC's own data, it is clear that:

> a. This current vaccination program for preventing

> N. meningitidis infections is not cost-effective

> even when the costs of the harms [6] caused to

> some of those vaccinated are not considered, and

> b. Any mass vaccination program for N.

> meningitidis using the current vaccines is an

> obvious waste of our healthcare dollars.

> [6] For example, in the period from January 2005

> through 2010, VAERS added about 7,095

> adverse events for children in the age range

> where the vaccines for N. meningitidis were

> listed, with reports of 20 deaths, 98 life-

> threatening adverse events, 49 instances of

> permanent disability, 3007 hospitalizations, 19

> extended hospitalizations and 2,412 emergency-

> room visits. Given a VAERS reporting history

> of less than 10 percent, multiplying the reported

> instances by 10 would still probably

> underestimate the real instances. On this basis,

> to save less than 130 N. meningitidis infections

> and the CDC's about " 9 " deaths annually, the

> current 'one dose' vaccination program at an

> uptake level of about 70 % probably annually

> causes in excess of 66 deaths, 161 permanent

> disabilities, 312 life threatening events, 1,006

> hospitalizations, 63 extended hospitalizations

> and 7,900 emergency room visits (see Table 3).

>

> Clearly, the risks associated with the current 'one

>dose' vaccination program outweigh the claimed

>benefits.

>

> Therefore, the CDC should immediately stop

>recommending any preventive mass vaccination

>program for N. meningitidis.

>

> In addition, recognizing that this mass vaccination

>program is an obvious waste of precious healthcare

>dollars, all of the affected States should immediately

>suspend all recommendations or mandates for the

> preventive vaccination against N. meningitidis.

>

> Then, each of the States should sue the vaccine

>makers on the behalf of their residents to recover

>the costs of the vaccination program and the injuries

>it caused from the vaccine makers, who obtained

>approvals for, sought inclusion in the US

>recommended vaccination program, and supplied

>'preventive' vaccines for four of the common

>invasive types of N. meningitidis, when they knew,

>should have known, and were responsible for

>knowing, that their approved vaccines were not-at-

>all cost-effective in significantly reducing each

>State's residents' long-term risk of infection by, or

>death from an infection by, any one of the nine

>types (serogroups) of Neisseria meningitidis, which

>are known to cause invasive disease (A, B, C, D, X,

>Y, Z, 29E and W-135) in the USA, including the

>diphtheria-toxoid- or Diphtheria-CRM197- linked

>antigens for the A, C, Y and W-135 types in the

>current diphtheria-toxin-conjugated vaccines.

>

>

> Independent Review of All CDC-recommended

> Preventive Vaccination Programs

>

> Finally, given the reality that the vaccines for

>N. meningitidis are not cost-effective, independent

>review should be made of all of the other

>vaccination programs.

>

> Those vaccines for which the overall costs,

>including the costs of the harm done to some and

>the costs associated with the vaccine-injuries and

>the vaccine-related deaths, indicate that a given

>prophylactic/preventive vaccine is not medically

>cost-effective under the current CDC/ACIP

>recommendations should either be removed from

>the national vaccination recommendations or, if

>truly cost-effective for all of is components at a

>reduced number of doses, the national vaccination

>recommendations should be scaled back to the point

>where the use of the vaccine is truly medically cost

>effective for all of its components.

>

> In instances, like, for example, the vaccine for

>measles, mumps, and rubella or the vaccines for

>diphtheria, tetanus and pertussis, where the

>vaccination program is not cost-effective for one

>or more components, the vaccine makers should be

>required to reformulate the vaccine to remove the

>component or components for which there is no true

>medical cost-effectiveness.

>

> Moreover, the CDC should immediately remove

>the " Meningoccocal " [7] and other non-cost-

>effective vaccines from its vaccination

>recommendations and use other public health

>strategies to address the rare cases of N.

>meningitidis occurring each year in the USA.

> [7] For example, the current CDC

> recommendations for " Meningococcal Vaccine "

> read:

> " 3. Meningococcal conjugate vaccine (MCV4).

> o Administer at age 11 or 12 years, or at age

> 13 through 18 years if not previously

> vaccinated.

> o Administer to previously unvaccinated

> college freshmen living in a dormitory.

> o Administer MCV4 to children aged 2

> through 10 years with persistent

> complement component deficiency,

> anatomic or functional asplenia, or certain

> other conditions placing them at high risk.

> o Administer to children previously

> vaccinated with MCV4 or MPSV4 who

> remain at increased risk after 3 years (if

> first dose administered at age 2 through 6

> years) or after 5 years (if first dose

> administered at age 7 years or older).

> Persons whose only risk factor is living in

> on-campus housing are not recommended to

> receive an additional dose. See MMWR

> 2009;58:1042-3. "

>

>

> Longer-term Corrective Actions

>

> Pre-approval Corrective Actions

>

> Unlike other types of drugs, the US Food and

>Drug Administration (FDA) approves vaccines without:

>a) any proof of in-use effectiveness for the

>claimed protection interval, mandating that the

>vaccine formulation does not produce any

>significant increase in adverse effects in a

>population of not less than 50,000 healthy

>individuals than those caused by a true placebo (i.e.,

>a pH 7.4, isotonic saline solution containing glucose

>at the level of the vaccine components), c)

>demanding that the risk of serious vaccination-

>associated adverse events be at least 10 times less

>than the risk of serious adverse events associated

>with the disease itself, and d) requiring the

>prospective manufacturer of the vaccine to prove

>that adding the " new " vaccine to the vaccination

>schedule will not adversely impact the long-term

>health of the actual population who will be

>vaccinated.

>

> The FDA should be compelled to immediately revise

>its current shoddy vaccine-approval process to require

>approval standards that are as high as, or higher than,

>those which are currently required for any other class

>of drug given as a disease preventive to healthy

>individuals where the drug can potentially cause both

>short-term and long-term harm.

>

> Post-approval Corrective Actions

>

> For all " new " [8] vaccines, the FDA should

>require a minimum 50-year follow up on the health

>of all those involved in any Phase 3 clinical trial

>used to obtain approval as well as a minimum 10-

>year follow-up on the first 1,000,000 individuals

>inoculated with the vaccine after its approval (an

>extended Phase 4 trial).

> [8] For the purpose of this discussion, any change

> in formulation with respect to any antibody

> component in an existing approved vaccine

> would render that vaccine a new vaccine and

> remove it from the NVICP's list for 10 years.

> Thus, of necessity, the NVICP would not cover

> the current ineffective influenza vaccines, which

> change antigens annually. Similarly, the new

> Pfizer/Wyeth Prevnar® 13 vaccine would not be

> covered by the NVICP until some time in 2020

> at the earliest.

>

> During the 10 years following approval of any

>new vaccine, the CDC should be prohibited from

>recommending that it be included in any

>government-recommended vaccination program.

>

> In addition, the government should be prevented

>from adding the new vaccine to the National

>Vaccine Injury Compensation Program's (NVICP's)

>list of covered vaccines.

>

> Furthermore, the CDC should be prevented from

>recommending the addition of any " booster " or

>additional dose of a vaccine to an existing

>vaccination program unless independent analysis of

>the data, including the direct and indirect costs

>associated with the harm from adverse reactions,

>clearly establishes that the additional dose is

>medically cost-effective.

>

> Moreover, whenever an additional dose of an

>FDA-approved, NVICP-covered vaccine is added to

>the US vaccination recommendations, it should be

>excluded from being covered by the NVICP for a

>period of not less than 10 years from the date the

>government recommends that dose.

>

> For all of the existing vaccine formulations

>approved for less than 5 years:

> 1. The formulation should be removed from the

> current US-recommended vaccination program

> unless: a) its current vaccination program were

> independently proven to be medically cost-

> effective and its risk of serious adverse

> reactions were independently proven to be 10

> times or more less than the rate of serious

> adverse reactions associated with the disease at

> the disease's pre-vaccine-approval rate of

> clinical cases.

> 2. For all vaccines removed from the US

> recommended vaccination program based on

> criterion " 1 " , the vaccines should be removed

> from the NVICP's list of covered vaccines and

> the removal should be retroactive to the

> vaccine's approval date.

>

> For all existing vaccine formulations approved for

>more than 5 years:

> 1. For vaccines that are given in multiple doses

> beyond an initial series of no more than 3 doses

> when they were originally approved, each

> additional dose should be removed from the US-

> recommended vaccination program unless: a) the

> current vaccination program, including the last

> recommended dose were independently proven

> to be medically cost effective and its risk of

> serious adverse reactions were independently

> proven to be 10 times, or more, less than the rate

> of serious adverse reactions associated with the

> disease at the disease's pre-vaccine-approval rate

> of clinical cases.

> 2. For vaccines in the US-recommended

> vaccination program for which the initial

> vaccination or vaccination series cannot be

> independently proven to be medically cost-

> effective when all costs, including those

> associated with vaccine-associated adverse

> events, are considered, the vaccine should be

> removed from the US-recommended vaccination

> program.

> 3. For booster doses or initial series that are

> independently determined not to be cost-

> effective in a mass vaccination program, the

> dose or doses that are not medically cost-

> effective should be removed from the NVICP

> program beginning on: a) the date the additional

> dose was recommended or , for non-cost-

> effective initial doses, the date the initial

> series was added to the recommended schedule.

>

> Finally, recognizing that the governmental

>agencies and the vaccine makers have knowingly

>failed to live up to their commitments to safen

>vaccines as set forth in the NVICP, except for the

>tax on each vaccine dose [9], the NVICP should be

>terminated by act of Congress in 2011.

> [9] The tax will need to continue to provide the

> funds the " vaccine court " needs to address the

> thousands of cases remaining in its backlog and

> to pay the compensation for those claimants,

> who have won or will win their case.

>

> When vaccines are approved and regulated in the

>same manner as other types of drugs and the

>vaccine makers are subject to the same legal

>liabilities that the makers of other types of drugs

>bear, then the marketplace may again 'incentivize'

>the vaccine makers to make safer vaccines.

>

> If vaccines truly are, as they are continually

>advertised, " the safest of medicines " , then, the

>vaccine makers have little to fear from the civil

>court system.

>

>

>

>About the writer, G. King, PhD

>

> G. King, PhD Analytical Chemist, is a

>scientist who has:

> * Intensively studied:

> x the use of mercury compounds in medicine,

> x vaccines and

> x vaccination programs

> for more than a decade,

> * Expressed his concerns to the FDA about the

> approval of Sanofi's Menactra in the review

> meeting held immediately before the FDA made

> its decision to approve this vaccine,

> * Established that he supports mass vaccination

> programs only when the vaccine has been proven

> to be reasonably safe, in-use effective, and

> clearly medically cost effective in the USA or

> other nation where medical cost-

> effectiveness [A] has been clearly established

> when all of the costs, including the costs of all of

> the vaccination-associated adverse events, have

> been properly considered.

> [A] In general, Dr. King has come to oppose

> approval of any mass vaccination program on

> a " societal cost " basis because such

> predeterminations have been repeatedly

> shown to overestimate the cost savings from

> the vaccination program.

> * Sorted out the underlying science to the extent

> that he could find such from all of the published

> information available from those with differing

> views about the vaccines currently recommended

> by the CDC as a prophylactic health measure for

> meningococcal meningitis and the 2005 - 2010

> and proposed 2011 vaccination programs using

> those vaccines (Sanofi's Menactra® and Novartis'

> MenVeo® ).

> Currently, Dr. King is pursuing a complete

> listing of the undisclosed ingredients in the

> MenVeo formulation, which, contrary to the

> clear labeling requirements set forth in 21

> CFR § 201.100 for parenteral (injected and

> infused) drugs (see §201.100((5)(iii)), was

> approved by the US FDA without the

> disclosure of the chemical name and, except

> for buffering agents and isotonic strength

> adjusters, the amount of each component in

> the vaccine on a per-dose basis.

>

> If any, after reading this article, the cited

>documents, or any other article published by this

>reviewer, you find any significant error for which

>there is unbiased science that clearly supports your

>alternative view, then, by all means, send your

>alternative view and the supporting documentation

>to me through dr-king@... and, if your studies

>are truly unbiased, this author will be glad to: a)

>modify his views accordingly and publish an

>updated article reflecting his modified views and

>crediting you and the unbiased supporting documents

>you submit.

>

> If you find areas where the text in this review has

>grammatical, spelling or word-usage errors, please

>let the author know so that he may appropriately

>correct them and publish an appropriately revised

>version of this article.

>

> For additional information about Dr. King, his

>interests and his writings, the reader can visit the

>Internet web site, http://www.dr-king.com/.

>

>

Please share this message with others who seek

to understand that only vaccination programs that

have been INDEPENDENTLY proven to be medically

cost-effective in a give nation or region should

be recommended for mass vaccination of the public

in that nation or region.

Thanking everyone in advance for all of your efforts,

no matter how small, to spread this document to the

four corners of the Earth. this reviewer remains ...

Respectfully,

G. King, PhD

http://www.dr-king.com

Founder, FAME Systems

PS: My apologies if you get more than one email as,

for this email, several lists have been merged

but all the duplicates may not have been removed.

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