Sunday, August 02, 2015

Sarbanes-Oxley for vaccines

We need a Sarbanes-Oxley type law for vaccines and other pharmaceuticals. 

Sarbanes-Oxley (SOX) was passed by Congress in 2002 following a series of corporate financial scandals (chiefly involving Enron, but there were others as well) in order to hold corporate boards and company officers accountable for how their business was conducted, in order to reduce the risk that they would engage in unethical practices. 

Merck is currently embroiled in a whistleblower lawsuit with two of their scientists alleging that the mumps portion of the MMR is not as efficacious as it has been represented. Merck has a monopoly on the MMR vaccine because of tests presumably demonstrating it has greater efficacy than other vaccines. The scientists are alleging that the tests were spiked to get the desired results. If the fraud is proved in court this may threaten Merck's monopoly of this portion of the vaccine market. 

An HIV vaccine researcher has been sentenced with jail for his fraudulent research. 

Why do we not have a similar requirement (ie: SOX) for the corporate heads and boards of pharmaceutical companies (as well as FDA/CDC/ACIP officials)? Would Vioxx have hurt and/or killed so many if they had been required to sign off on the nature and manner (ie: the quality and soundness) of the research done to justify its development and approval? 

If we had this sort of requirement would we have editorials (Marcia Angell, former editor of the New England Journal of Medicine) by major researchers decrying (John Ioannidis) the poor quality (Richard Smith, former editor of The British Medical Journal) of studies healthcare providers are using as a basis for care? 

What good are IRBs (Institutional Review Boards) doing given all of the above? If they are doing their job why is it that we cannot trust the research that is being published? In theory the IRBs are the first line of defense against bad research and peer-review prior to publication is the second. Apparently these safeguards are not working or are themselves seriously compromised.  

Even if our Congress were to pass such a law (an event I consider unlikely given the influence of the pharma lobby upon them), and even if research were strengthened so the results were more trustworthy it would still be my position that we deserve freedom in medical decision-making, including receipt or declination of vaccination.  

Wednesday, July 29, 2015

Data dump, the CDC way ...

Ordinarily a "data dump" means downloading a large batch of data so one can comb through it and examine the contents for meaningful analysis. 

But when it comes to vaccine related study data the term takes on a new and different meaning. It is now alleged (by Dr. William Thompson, aka the "CDC Whistleblower") that he and his colleagues met to destroy (dump in a garbage can) documents linking an increased risk of autism with receipt of an MMR vaccine prior to 36 months (particularly in black males). 

In his statement Dr. Thompson refers to the Verstraten study - a study often cited as "proof" that there is no association between the preservative thimerosal (a form of mercury) and autism - and he refers to it as a "debacle"! Here is one analysis as to why this "study" is rightly called a debacle. 

While Dr. Thompson kept silent until 2014 he at least had enough sense of personal ethics not to destroy his own copies - he didn't dump his data. He also finally responded to the nagging of his conscience about this matter. 

As Congressman Posey has stated, a thorough investigation and congressional hearings are called for. 

What's also called for is a return to greater freedom in medical decision-making ... those who want vaccines should get them, those who decline should not face an retaliation for this decision. Vaccination should not be linked to school participation, employment, nor anything else. 

Thursday, July 23, 2015

Vaccination - A Useful Tool ... for genetic alteration

Epigenetics studies how exposures (through diet, chemicals, lifestyle, etc) alters the expression of our genes - turning genes on or off essentially. 

But we are moving into an era of genetic modification - of altering the genome itself (a permanent change that could be passed on to the next generation), not changing whether a gene is or is not expressed (which, in theory, is temporary). 

So many have been trained to accept vaccination without question - and this is one way that vaccination could be so very useful as a tool to alter the genome of a population. 

A concept called "Immunoprophylaxis by Gene Transfer" is being researched - human trials have already begun. It involves inserting synthetic genetic material into the genome of the host by injection into the muscle. There is no way to control where the synthetic genes go - no way to limit which tissue into which they are inserted - so yes, this synthetic genetic material could be transmitted to the next generation. 

But who's to say this hasn't already happened? How do we know it hasn't? Genetic material from substrates used to produce vaccines are a known contaminant - human DNA from cell lines from aborted babies is used in various vaccines (WI-38, MRC-5, PER C6, HEK-293, among others). This is no different for vaccines developed using animal tissues as substrates as well (chicken eggs, monkey kidneys, insects, for starters). SV40 (Simian, or monkey Virus 40) was a horrible scandal in the polio vaccine program. 

While IGT may be initially developed for all the right reasons - to help people - knowing human nature (sinful) there can be no reassurance that it may well be used for more sinister reasons. One blogger is already speculating about how this sort of technology could be used. 

For all that we do know about vaccination there is much that we don't know - and for this reason, no one should be required to be vaccinated. Linking vaccination to employment, or school or anything else is coercive - "soft" force, if there is such a thing. This is one of many areas of life that people must have freedom to determine what they will to do. 

Saturday, July 04, 2015

First US measles death - some questions for consideration

Earlier this year a young woman (exact age unknown) died of pneumonia in Clallum County in Washington State, the first official, or documented measles-related death in the USA since 2003. Pneumonia is a known complication of measles. While her death is tragic, as is common in many deaths from secondary complications (well, or even primary causes) she reportedly had other health issues that increased her risk of death from an infection (measles or otherwise). 

Here is what has been reported: 
- She had more than 1 medical conditions 
- She was on multiple medications, including immune suppressing drugs 
- She did not have the rash typical of measles so the presence of measles was not 
  discovered until the autopsy was done. 
- She had Type D9 strain of measles

Here is what is unknown: 
  verbal report of her family members, though they did not have written documentation of 
  her vaccination status.  
- In what tissue the measles was found (gut, lung, brain, other). 
- Her nutrition status (Vitamin A, in particular, is important to recovery from measles; Vit D3
  is also an immune-modulator - not showing overt signs of deficiency of a vitamin is not 
  proof of sufficiency, or having enough of the substrate to maximize your body's ability to
  manage an infection). 

She is believed to have been exposed when in the same facility at the same time as a person who later developed a rash and was diagnosed with measles. Were they in the same room? Yes - measles is highly contagious - but how close was their contact? If they were merely in the same facility at the same time (but not in the same room) why did others not also come down with measles - hospitals are filled with people who are immune compromised for a variety of reasons. Certainly she was not the only immune-compromised person who was exposed. Yet she was the only one to become sick ... and she was likely vaccinated as well.

No one died during the Disneyland outbreak, yet there was a great hugh and cry - this woman died from an illness that is presumed to be measles associated yet there was very little chatter. Why? 

If she had had measles as a child (spontaneous, "wild" infection), perhaps she never would have developed this pneumonia at all, as recovery from spontaneous infection from measles is known to provide more robust, and longer-lasting immunity than artificial, man-made, temporary risk-reduction via vaccination. That is why those born before 1957 didn't need to be vaccinated - they were presumed to be protected by having had and recovered from a community acquired infection. 

Because nothing is risk free, and because all decisions have both risks and benefits the writer of Vaccine Depot believes in freedom in healthcare decision-making ... if you want to be vaccinated, you should get whatever vaccines you think you need. Conversely, those who are not convinced the benefit of vaccines is greater than the risk should be free to make that decision as well. 




Monday, June 08, 2015

VE Voodoo

VE is Vaccine Effectiveness - an estimate of how well a vaccine does (or does not) work. 

The VE for the 2014 - 2015 flu vaccine was 18% (with a 95% Confidence Interval of 6-29%); 

Perhaps I could have titled this one "How a Confidence Interval can be a Confidential Informant". 

In statistics, the Confidence Interval (or CI) is interpreted as giving the range within which we can be x certain (in this case, 95%) that the true effect exists. In general, the wider the interval between the two numbers the less certain one can be of the effect. The width of the CI is influenced by the sample size of the study - and in general the larger the study the smaller the width of the CI, providing greater confidence in the precision of the estimation of the effect in question. 

The CI associated with the CDC's VE for flu vaccines in the 2014 - 2015 influenza season is wide. It is unknown how large was the sample size used to generate the VE (this information is not provided). But if the sample size was large a wide CI is all the more concerning.  In their report they do at least acknowledge "reduced protection" and indirectly allude to the fact that even when the vaccine strain is well-matched to the circulating strain VE is about 50% at best. 

But then the last paragraph of the report contains this sentence: "None of the VE estimates by age for this season are statistically significant at this time." A polite way of saying that even the 18% VE may well be meaningless - that there may have been no statistically significant effect from the vaccine at all, or that it didn't work. At all. 

Given this information, how is it rational to demand healthcare workers use this product or risk losing their jobs? How can healthcare providers recommend this to a client? Why is the government and why are health insurers paying for this product? Why accept the risks of using this product when the odds of benefit are so slim (even IF the risk of harm is low)? 

No one should be forced to use a vaccine - nor manipulated, nor coerced in any way, shape, or form. Being threatened with loss of employment is a form of manipulation and/or coercion. Being threatened with not being able to go to school because you have not been vaccinated is likewise manipulative and coercive - it causes people to make a medical decision under an influence other than objective information and it introduces a third party into a relationship (and decision) that should be private. 

We deserve better - especially from people whose salaries we pay (ie: CDC officials). 
 

Sunday, May 24, 2015

Podcast Post - raw notes (Siegel/Vaccine Myth May 10, 2015)

One of the benefits of long commutes is having time to listen to podcasts - and I've come to appreciate being able to do this. It's also something I'll do on my days off (when I'm not listening to talk radio). 

This post contains raw notes I jotted down as I listened to the May 10, 2015 episode of Shawn Siegel's show "The Vaccine Myth: An Issue of Trust" - he has a YouTube channel, and you can listen live to his how on the Logos Radio Network as well. I subscribe to the podcast (via iTunes) and listen when I can.  

The guest on this episode was Dr. Suzanne Humphries, and she discusses some interesting tidbits of information she's unearthed in her research. From what I've observed, those who question the paradigm of vaccination are more transparent than those who accept it. At at least two points in the program she acknowledges criticism of her book Dissolving Illusions (co-written with Roman Bystrianyk) and answers the criticisms - without resorting to ad hominem attacks of her critics. 

These notes may serve as a starting off point for further research for myself ... or anyone else (though I encourage you to listen to the show yourself - check against my notes!) 

They focus primarily on the measles vaccine during the discussion. 

Lungs have immune cells with CD150 receptors (only immune cells have this type of receptor); The virus targets these receptors (in the natural/spontaneous infection) and it takes about 1 week before it is in the body - first the lymph, then the reticulo-endothelial system ... at which point you begin to show symptoms (Koplik's spots in the mouth, rash, 
fever, cough, etc ...); 

Nectin 4 receptors? 

"Passaging" described - part of the manufacture of measles vaccine (or perhaps its initial development). Cultured on a variety of tissues - human kidney/chorion, monkey kidney, human diploid cells (from aborted fetuses); Vero cells (from monkey kidneys) have CD 46 receptors to which the wild measles virus does not have an affinity - though that changed as a result of techniques used to develop the vaccine strain used in measles vaccines. CD 46 receptors are present on every nucleated cell (ie: all cells in the body except mature red blood cells); 

Measles virus has "H" protein ... virus mutates over time. 

Discussed research about response of vaccinated vs unvaccinated when exposed to wild measles - vac have inferior response compared to unvac (Poland study?);

Measles without rash - increased risk of chronic disease. 

Low-grade chronic infection circulating throughout vaccinated population that manifests as actual full-blown disease when enough people (vac and/or unvac) are susceptible. 

They also touched on Pertussis/Whooping Cough (WC) - discussed theory that the vaccinated may be the source of the mutated bacteria that do not have pertactin and this may be one facet of why the WC vaccine is less effective. This is due in part to the development of "immunity" via injection rather than through the lung tissue (has implications for measles as well since that is also primarily a respiratory virus) - if/when the vaccinated are exposed to disease and subsequently recover may harbor bacteria longer which has allowed it to mutate so the vaccine is less effective. (not sure if this is related to baboon study showing vaccinated as a reservoir of infection).

Dr. VK Singh - testified before congress regarding MMR and auto-immunity/autism 

Dr. Steven Walker 

Pabst study 1997 

Discussed reluctance and/or difficulty of many researchers to pursue research that is perceived as being "anti-vaccine" as it kills careers and ends funding ... being "Wakefielded" (so the issue is not necessarily truth, let alone facts ... science should not be agenda driven, yet it is, as is any human endeavor). 

T cell key to eliminating measles, cellular immune system key, especially with measles. 

Death is used as a way to "persuade" people to accept vaccine even though death rate had decreased to ~500/year (incidence of 3-4 million/year) prior to implementing vaccine.  

These notes are **very** raw and virtually unedited (I typed them up after the fact - they might have more detail and fewer omissions/errors if I had been typing them as I listened but that's not what happened). The interview touched on more that I have forgotten because I wasn't able to write it down (since I frequently listen as I drive!) so I hope you listen to the show and/or episode as well ... and compare your notes to mine! 

Ultimately, those who want vaccines should get them (hardly the position of someone who is "anti-vaccine"!) ... this writer appreciates that we are designed by our Creator (Jesus) to live in freedom. 

Either way, if you decide to receive a vaccine or have your children vaccinated you should be convinced, satisfied in the amount and veracity/trustworthiness of the information upon which you base your decision - and that your decision should be freely made, not coerced, forced, nor manipulated in any way.  


Sunday, May 10, 2015

Not such a happy Mother's Day

All mother's want their children to be healthy, and few things warm a mother's heart than knowing that their child(ren) are safe and thriving. This is universal for all parents, but late last week two 1 month old infants died in Mexico after receiving a variety of vaccinations (39 others are hospitalized). To their credit the Mexican government has suspended all vaccinations while they investigate. They had received 3 vaccinations simultaneously - tuberculosis, rotavirus, and Hepatitis B vaccines. Because they received multiple vaccinations simultaneously it will be all the more difficult to determine if it was one particular vaccine that was the primary cause or if there was a synergy in receiving multiple vaccines at the same time that resulted in the deaths. The practice of giving multiple vaccines at the same time is poorly studied as vaccines are simply added to the schedule once they are approved and deemed "safe and effective".

The last paragraph of the article includes the knee-jerk disclaimer that vaccines are in important public health strategy but all medications have risks, etc ... this politically correct statement has begun to fall rather flat, as it is nothing but a token acknowledgement of reality - yet (at least in the United States) it is increasingly difficult to avoid vaccination - there is little choice in the matter, so there is no way for individuals to avoid the risks and while the "herd" may have a short-term benefit, the collective group bears no responsibility when adverse events (like DEATH) occur.

My heart aches for these families - they were doing what they thought was best for their children (and as many think, fulfilling their "duty" to society), yet the result was tragedy. I pray for their comfort and peace as they grieve.

I don't doubt the motive of the parents, or of public health officials (and others) who fervently believe in the necessity of vaccination. I do wish someone would describe how many deaths as a result of vaccination is acceptable ... how many adverse events (either short or long term) ... and why policy makers refuse to insist upon LOTS of studies comparing the vaccinated with the unvaccinated (in both short term health and long term health) as that is the kind of information that would help both policy makers and parents and adult individuals decide what level of risk/benefit ratio with which they are willing to live.

Why are those who set vaccine policy permitted to be financially conflicted and connected with vaccine manufacturers when both benefit financially from the decision to use vaccines? Why do we not insist that those who set vaccine policy have no financial relationship with vaccine manufacturers, ever - not before they set policy, not after they set policy (Dr. Julie Gerberding, Dr. Paul Offit among many, many others). 

I hope Mexican public health officials have the backbone, and integrity, to not allow the vaccine makers the cover of the "Wyeth strategy" in response to these tragic outcomes. While Mexico was not included in this study I hope Mexican health policy makers consider its implications - that more vaccines do not necessarily mean better health.

 Because we do not have good data comparing short and long term health outcomes between vaccinated and unvaccinated individuals it is difficult for individuals to determine the level of participation in vaccination with which they are comfortable - what vaccines they may want, what they do not want.

Because vaccines have been declared both "safe and effective" by policy makers saddled with conflict of interest and also "unavoidably unsafe" (so says the SCOTUS in Bruesewitz v Wyeth, 2011) people must be able to decide for themselves what vaccines they use and when they use them.


http://mexiconewsdaily.com/news/two-infants-dead-after-receiving-vaccinations/