[FAME Systems] Comments to IOM committee -- Re: Safety Eval of Childhood Different Vaccination Schedules

[Guest guest]

All,

Attached are my comments to Committee of the Assessment of

Studies of Health Outcomes Related to the Childhood

Immunization Schedule on “Study Designs for the Safety

Evaluation of Different Childhood Immunization Schedules”

For those who do not receive attachments, the rough text of

those comments reads as follows:

  Comments to IOM Committee Concerning

  “Study Designs for the Safety Evaluation of

  Different Childhood Vaccination Schedules”

  Comments to the Institute of Medicine’s BPH

  Committee of the Assessment of Studies of Health

  Outcomes Related to the Childhood Immunization

  Schedule on “Study Designs for the Safety

  Evaluation of Different Childhood Immunization

  Schedules” submitted to:

http://www.surveygizmo.com/s3/927011/BPH-Committee-on-the-Assessment-of-Studies-of-Health-Outcomes-Related-to-the-Childhood-Immunization-Schedule

  on 20 July 2012.

  The “Introduction” to “Study Designs for

the Safety

  Evaluation of Different Childhood Immunization

  Schedules” begins by stating a premise,

   “Before approval by the Food and Drug

    Administration (FDA), vaccines are evaluated

    for efficacy and safety using large phase III

    randomized controlled trials”,

  that is: a) not supported by the facts and

based

  on trial designs that are not scientifically sound.

  Specifically, the safety studies fail to use a “true

  placebo” [1] as the control for safety purposes.

  [1] By definition, for injected vaccines or those

      administered orally or nasally, a “true placebo”

      would be an equivalent dose of a sterile isotonic

      pH 7.04, buffered saline solution containing a

      level of glucose equivalent to the overall level

      of all of the vaccine antigens.

  In addition, the efficacy studies are often flawed

  because the level of antibodies is not measured

  using human antiserum but rather an animal

  antiserum surrogate is used to measure the level

  of human antibodies that each subject develops.

  Further, after: a) the initial inoculation series

  proves that the vaccine is “safe enough” against a

  “true placebo”; the level of antibodies developed

  is measured; and c) the percentage of those who are

  vaccinated who have an adequate antibody titer is

  computed to determine the efficacy percentage,

  there is no “disease challenge”[2] in a volunteered

  group of those who are vaccinated and have the

  sufficient antibody levels (titers) to prove that those

  individuals have been actually protected by the

  vaccination series from contracting the disease.

  [2] In a “disease challenge”, a volunteer group

      of not less than 10% of those who: a) were

      inoculated with the vaccine and have developed

      a protective level of antibodies to the disease

      are naturally exposed to the “wild”, “native” or

      “circulating” strain or strains of the disease and

      then monitored for twice the disease incubation

      period to ascertain the percentage of those who

      were fully protected from contracting the disease

      after being exposed to it.

  Thus, before any scientifically sound and

  appropriate vaccination program trials can begin

  to be designed, researchers should first conduct

  those missing scientifically sound and appropriate

  studies that prove that each individual vaccine

  component is: a) “safe enough”, “efficacious”

  (produces appropriate levels of antibodies in not

  less than 95% of those who have received the initial

  vaccine series of not more than 3 doses of a given

  vaccine component) and c) “effective” (when an

  appropriate subset of the “vaccine protected group”

  is challenged by the most virulent “wild”/”native”/

  ”circulating” strain of the disease, the vaccination

  series prevents those vaccinated from contracting

  the disease in more than 95% of those who have an

  “protective” antibody titer and attenuates the

  severity and/or duration of the disease in the

  remaining 5%).

  Lest any raise the issue of ethics concerning the

  “disease-challenge” of volunteered inoculated

  children who have an “efficacious” level of

  disease-specific antibodies that have been claimed

  to be disease protective, without this disease-

  challenge to prove that the vaccines are truly

  effective, then it is clearly unethical to recommend

  that any child be exposed to vaccine disease-

  components that are not known/have not been

proven

  to be effective in preventing those so inoculated

  from contracting the disease for which that vaccine

  disease-component is claimed to be protective.

  Having read several package inserts where the

  vaccine manufacture makes no claim that the

  vaccine is effective in preventing those “fully”

  inoculated with their vaccine from contracting

  the disease or diseases for which the vaccine is

  used as a disease preventive measure, it is clear

  that the in-use effectiveness of each currently FDA-

  approved vaccine under the current CDC-recommended

  initial vaccination program must be established for

  each individual vaccine before any scientifically

  sound and appropriate program to study the effects

  of changes to the status quo should be attempted.

  In addition, those vaccines for which the number

  of doses currently recommended by the CDC renders

  the vaccine not societally cost effective should

  be excluded from any such study, their CDC

  recommendations for mass use should be rescinded;

  and such vaccines should be removed from

  coverage by the National Vaccine Injury

  Compensation Program. 

  IF: under the current CDC-recommended

  inoculation schedule, a vaccine is not at least

  societally cost-effective[3], THEN: how can

  anyone justify continuing the mass use of that

  vaccine?

  [3] For example, though the varicella vaccine

      was only marginally societally cost effective

      under its pre-approval assumptions for a single

      dose; the initial cost of the vaccine was higher

      than the pre-approval cost for cost-effectiveness;

      the single-dose program failed to provide the

      promised results; and even the two-dose program,

      which is currently not more than 80% efficacious

      in the short term, is clearly neither effective

      nor cost-effective on any scientifically sound

      basis, the CDC continues to recommend what is

      now a two-dose-plus vaccination program that is

      clearly a waste of precious healthcare dollars.

      This waste of healthcare dollars and any other

      like it should be immediately stopped.

  In closing, the simple message is that, before

  attempting to design any study, each vaccine that

  is to be included in any such study should first

  be proven to be truly “safe”, “efficacious” and

  “effective” based on scientifically sound and

  appropriate studies.

  Unfortunately, in many, if not all, instances,

  the Phase III clinical studies used by the

  manufacturers to obtain FDA approvals for their

  vaccines are neither scientifically sound nor

  designed to provide proof that the vaccine is

  actually effective in preventing disease in

  those who: a) are “fully” vaccinated; develop

  more than adequate disease-specific antibody

  titers (levels); and c) are subsequently exposed

  to the most virulent form of the “wild”/“native”/

  “circulating” strain(s) of the disease!

  Hopefully, after reading these comments, the

  Institute of Medicine (IOM) committee seeking

  these comments will shelve these studies and,

  for those vaccination programs that are truly

  cost effective when all of the costs are

  considered, demand that the missing but

  required scientifically sound and appropriate

  studies, as defined in these comments, be

  conducted for each vaccine before any future

  studies are conducted on alternatives to the

  current vaccination schedules.

  Until the foundation for each of the existing

  vaccines is proven to be scientifically sound

  with respect to safety, efficacy, effectiveness,

  and cost-effectiveness, all study designs that

  seek to study the effects of any perturbation

  of the overall vaccination program will be

  built on a claimed but non-existent foundation

  that will, at best, doom them to scientific

  failure.

Hopefully, you will carefully

read these comments and, to the extent that you are

able, will forward and distribute these comments as widely

as possible.

Respectfully,

Dr. King,

http://dr-king.com

Founder, FAME Systems