EDITORIAL for Monday 1 October 2018


Welcome to the current edition of i2P (Information to Pharmacists) E-Magazine dated Monday 1 October 2018.
Since our last edition we have seen the implosion of the Cochrane Collaboration – an organisation that had built an impeccable reputation in the area of evidence-based medicine that could be relied upon by health professionals around the world.

It appears that Big Pharma has infiltrated funding and influence sufficient to demand the removal of  Peter Gøtzsche MD, Dr MedSci, MSc, the director of the Nordic Cochrane Centre at the Rigshospitalet, Copenhagen, Denmark.
He has been expelled from membership of the Governing Board of the Cochrane Collaboration, a position to which he was elected in early 2017.
Gøtzsche and colleagues harshly criticized a Cochrane review of the human papillomavirus (HPV) vaccine, describing it as incomplete and biased.
In the i2P “Safe Vaccine Debate” column in the edition dated 19 August 2018 – Item #3 discussed a report on the same HPV issue combined with an open letter written by Elizabeth Hart from the Overvaccination website, giving detail of the massive conflict of interest that existed to produce a “whitewash” report on HPV.

We re-publish both items from the i2P link Item #3

i2P: The UK Pharmaceutical Journal reported on 14 August 2018: “An ‘urgent’ investigation is being launched by Cochrane into its review of human papilloma virus (HPV) vaccine safety after criticisms from researchers about its findings.
According to BMJ Evidence Based Medicine, a Cochrane HPV vaccine review, published in May 2017, which had given the all-clear to vaccines designed to prevent cervical cancer, did not include all the relevant trials and ignored possible sources of bias. 
Critics said the review “failed to meet the needs of citizens or healthcare providers who rely on Cochrane reviews”.
The review based its conclusions on 26 studies involving 73,428 women. 
But it could have included as many as 46 trials involving more than 120,000 women, according to researchers Lars Jørgensen and Peter Gøtzsche from the Nordic Cochrane Centre in Copenhagen, and Tom Jefferson of the Centre for Evidence Based Medicine in Oxford.”

Elizabeth Hart wrote:

For the attention of:
Dr David Tovey
Editor in Chief
Cochrane

Dr Tovey, the recently published Cochrane HPV vaccine review[1] is severely compromised and cannot be trusted due to the conflicts of interest of authors on the original protocol and the final review document.
Due to serious conflicts of interests, Cochrane should withdraw this review.

Dr Tovey, in February 2016, I challenged you directly about protocol author Lauri Markowitz’s conflicts of interest, see previous correspondence in the email thread below.
Catherine Riva et al raised the problem of conflicts of interest in December 2014 in a comment on the original protocol[2], specifically pointing out the failure to properly disclose conflicts of interest by Lauri Markowitz and Marc Arbyn.
Lauri Markowitz is an employee of the US Centers for Disease Control and Prevention (CDC), and is involved in HPV vaccination promotion.

The US Government benefits from the sale of HPV vaccine products, i.e. a letter to Dr Eric Suba from the US National Archives and Records Administration (November 2010) discusses royalties the US National Institutes of Health (NIH) receives from the sales of HPV vaccines.  
Indicating a stunning lack of transparency, it appears the value of these royalties is kept secret, i.e. it is protected from disclosure under the US Freedom of Information Act. (See copy of letter attached.)

The NIH Office of Technology Transfer (OTT) oversaw the patenting of the HPV vaccine technology and licensed the technology to Merck, the maker of Gardasil, which sought approval for Gardasil around the world, working with the PATH group, with support from the Bill and Melinda Gates Foundation, in distributing the HPV vaccine in developing countries.[3]  The HPV vaccine technology was also licensed to GlaxoSmithKline[4].

The Bill and Melinda Gates Foundation has been very influential in promoting HPV vaccination[5]. In regards to the Cochrane HPV vaccine review, Cochrane has a conflict of interest in that it is a beneficiary of Bill and Melinda Gates Foundation funding, i.e. to “support the development of Cochrane’s next generation evidence system, with a specific focus on maternal and child health”.[6]  The World Mercury Project has provided critical analysis of Cochrane’s conflicts of interest via the Bill and Melinda Gates Foundation and other organisations[7].

Dr Tovey, as a matter of urgency, Cochrane needs to consider conflicts of interest in its undertakings, as these are compromising Cochrane’s mission to provide credible and unbiased information to support informed health decision-making.
In regards to the Cochrane HPV vaccine review, it’s alarming that an employee of a US government agency promoting HPV vaccination was involved in the Cochrane protocol to evaluate the immunogenicity, clinical efficacy, and safety of HPV vaccines when there is a clear conflict of interest, i.e. it is in the US Government’s interest to justify and defend the use of HPV vaccine products. 

How and why was Lauri Markowitz’s participation in this Cochrane review approved by Cochrane?

In my previous correspondence to you in February 2016, I noted Markowitz is an author on many papers about HPV vaccination, for example Prevalence of HPV After Introduction of the Vaccination Program in the United States[8], a paper which received acclaim in the mainstream media, see for example this article published in Forbes magazine: HPV Infection Rates Plummet in Young Women Due to Vaccine[9].
I also noted Markowitz was on the US Advisory Committee on Immunization Practices’ Human Papillomavirus Vaccine Working group in 2006, and that she is the ‘corresponding preparer’ on the ACIP’s document recommending implementation of HPV vaccination[10].
I queried how Markowitiz could possibly be an objective and independent reviewer of the literature regarding HPV vaccination, and also queried on what basis Lauri Markowitz was engaged to conduct the Cochrane review of HPV vaccines.

Your response to me on 1 March 2016 included: “We can’t govern the opinions that review authors hold although we are stricter than other journals about conflicts of interests – in that declaration is not always sufficient. We have safeguards in place to avoid bias due to non financial conflicts although I acknowledge these cannot currently be fully controlled – but these include insisting on teams of authors, peer review at both the protocol and review stage, detailed editing by the appropriate Cochrane Review Group plus oversight by my Editorial Unit.”

It appears that Cochrane does not have an effective system to evaluate conflicts of interest either of Cochrane itself or its authors.
Dr Tovey, you did not clarify on what basis Lauri Markowitz was engaged to conduct the Cochrane review of HPV vaccines.

Can you please explain how this came about?
Who initiated the HPV vaccine review protocol?

Subsequently Lauri Markowitz was not included as an author on the final Cochrane HPV vaccine review, so it appears there was an appreciation this was not appropriate.
But the fact remains she was influential in the development of the protocol, which was acknowledged in the final review, along with her “invaluable advice and contributions by reviewing the results and discussion sections”.
As a citizen interested in HPV vaccination I had hoped to rely on an objective and unbiased review by Cochrane, but I do not trust this review and do not consider it to be a document of value.

Dr Tovey, the Cochrane HPV vaccine review is severely compromised.
It is demonstrably not independent and cannot be trusted.
The Cochrane HPV vaccine review should be withdrawn.
Cochrane also needs to urgently consider its own position in regards to conflicts of interest, and the impact on Cochrane’s credibility, independence and trustworthiness.

I request your response on this matter.

Elizabeth Hart

References:

    1. Marc Arbyn, Lan Xu, Cindy Simoens and Pierre PL Martin-Hirsch. Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors. Cochrane Systematic Review. Published 9 May 2018.
    2. Marc Arbyn, Andrew Bryant, Pierre PL Martin-Hirsch, Lan Xu, Cindy Simoens and Lauri Markowitz. Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors. Cochrane Protocol. Published 30 December 2013.
    3. NIH Technology Licensed to Merck for HPV Vaccine: https://www.ott.nih.gov/news/nih-technology-licensed-merck-hpv-vaccine
    4. HHS-Licensed Products Approved by the FDA: https://www.ott.nih.gov/reportsstats/hhs-licensed-products-approved-fda
    5. See for example Summary of Bill & Melinda Gates Foundation-supported HPV Vaccine Partner Activities: http://www.who.int/immunization/sage/HPV_partner_info_gates.pdf
    6. Cochrane announces support of new donor: https://www.cochrane.org/news/cochrane-announces-support-new-donor
    7.  Are Cochrane Reviews Truly “Independent and Transparent”? World Mercury Project. 5 June 2018: https://worldmercuryproject.org/news/are-cochrane-reviews-truly-independent-and-transparent/
    8. Markowitz LE et al. Prevalence of HPV After Introduction of the Vaccination Program in the United States. Pediatrics. 2016 Mar;137(3):e20151968. doi: 10.1542/peds.2015-1968. Epub 2016 Feb 22.
    9. Tara Haelle. HPV Infection Rates Plummet In Young Women Due To Vaccine. Forbes. 23 February 2016: https://www.forbes.com/sites/tarahaelle/2016/02/23/hpv-infection-rates-plummet-in-young-women-due-to-vaccine/
    10. Quadrivalent Human Papillomavirus Vaccine. Recommendations of the Advisory Committee on Immunization Practices (ACIP): https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5602a1.htm

After Gøtzsche’s expulsion, four other members of the governing board resigned — Gerald Gartlehner, David Hammerstein Mintz, Joerg Meerpohl, and Nancy Santesso — the Cochrane Collaboration Governing Board announced on September 15.

The shake-up comes at a rather awkward moment, as the announcement was made just as a large international meeting of the organization was unfolding.
The 25th Cochrane Colloquium is taking place September 16-18 in Edinburgh, Scotland, with 1300 participants from 57 countries.  

Gøtzsche has been described as “one of the founding fathers” of Cochrane, back in 1993, and has appeared as an author on 17 Cochrane reviews.
He was elected to the Governing Board of the Cochrane Collaboration in early 2017.

The future of Cochrane is now very much in doubt because of the external influences that seem to be improperly driving direction, including the pressure to expel  Peter Gøtzsche given that he was found not to have breached any Cochrane protocols (the behaviour he was accused of breaching).
Peter Gøtzsche has defended himself in a 3-page letter titled moral_crisis_in_cochrane that all health professionals need to read, because the demise of Cochrane now leaves a void, with no credible source of evidence-based medicine as a ready replacement.

The news about Cochrane follows on from the outcome of the Royal Commission into the Australian Banking Industry and almost daily disclosures of unethical, even criminal behaviour from a range of major corporations ranging from insurance companies to communications industries (Telstra), even extending to behaviour relating to the independence of the ABC and revelations from a Senate investigation of the National Health and Medical Recommendation Council (NHMRC) that they performed improper investigations into homeopthy and other natural health modalities.
The entire world seems to be collapsing under the weight of crime and corruption.

The question arises: will any of the above improve after they have been fully investigated?
I think it will be “business as usual” unless regulating authorities begin enforcing and punishing the responsible persons with gaol terms – beginning with bank executives!

The lead article for this edition delivers criticism for the slow introduction of change and direction, resulting from pharmacy leadership deficiencies, in part, caused by an infection of some of the issues noted above.
When the PBS was first introduced to Australia, official pharmacy had to play “catch up” because pharmacy leaders were inexperienced in the art of political negotiation.
That deficiency was eventually overcome, and the PGA in particular, earned a reputation for being a strong and competent lobby group.
Unfortunately for pharmacy overall, those lobbying skills were utilised against lesser experienced segments of the pharmacy profession, creating disunity, an imbalance of power and poor cultural development.
That situation unfortunately allowed a distortion to occur in the overall strategic direction for pharmacy, and from which the profession is still trying extricate itself.
The PGA CP2025 is a valid strategic exercise that should have been in place decades ago, and yet is still being put together without any real sense of urgency.
Read: Community Pharmacy Market Research – Very Slow in Uptake

i2P has commented on NHMRC dishonesty on a number of occasions, giving a detailed account on how distortions were introduced for their investigations into homeopathy.
This once highly respected organisation is now thoroughly discredited and its reputation now lies in tatters along with that of our major banks and other leading corporations.
This behaviour must be stopped because it is affecting every fibre of our community.
Regulators must be more vigilant and actually perform appropriate enforcement of any action that suggests malpractice – or worse.
Read: NHMRC – Science Fact or Fiction?

WHO has made a statement saying that cannabis should be decriminalised world-wide because existing laws cause health discrimination.
In Australia, patients are being actively discriminated against as police are instructed to enforce existing laws and close down “illegal” supplies, leaving critically ill people with no workable solutions for their health problems.
Flawed health policy generates bad laws and lowered community respect for policy and laws.
Yet again, Pharmacy is in a position to provide solutions very simply and simultaneously create opportunity for the profession to treat chronically ill patients efficiently and economically.
Pharmacy leaders need to be proactive in the regulatory area because other health professionals are actively competing to lock pharmacy out of any opportunity whatsoever.
Potential for pharmacists is found in the compounding of THC and CBD in specific ratios to match the best result for patients with chronic illness.
Further pharmacist potential also lies in using cannabinoids in harm minimisation programs involving opioid dependencies and as an adjunct for the management of pain.
Pharmacists also need to be active and have a voice in the regulation of these substances ensuring that maximum patient access can be obtained through the application of Schedule 3 of the Poison’s Act.
Read: Understanding Medical Cannabis – 1. The Canberra Times:  New Labor bill would make using and growing cannabis legal in Canberra 2. Cannabis Tech: With Legalization Looming, Police Face Challenges Measuring Cannabis Impairment 3. Medical Marijuana, Inc. News: New Study Shows Marijuana Effective For Wide Array of Symptoms

Vaccine safety is compromised by a range of additives like mercury and aluminium. Less talked about are components like fetal cells that are commonly used in vaccine production, and add another safety issue as well as an ethical and moral issue. The author of this article has requested anonymity, which we have observed by delegating its editing to an i2P staff writer. It is published for your professional interest and for the provision of informed patient consent, as appropriate.
Read: Vaccines and the use of Live Delivery Abortion to Order

We often hear the expression “The science is settled,” however, science is a process.
The idea that “science” cannot consider new information contradicts the definition of science.
People who promote vaccination as an extreme medical ideology are involved in “scientism” – the manipulation of the science surrounding vaccines.
And it is certainly “unsettling” to hear the dishonest scientism claims that blare out in all forms of media.
“First do no harm” is the concept that underwrites all medical practice. Australian vaccination policy is so poor and damaging, that it beggars belief that legislators can be so close to manufacturer sales objectives as to guarantee them a market through coercive legislation that involves simultaneous removal of patient choice.
The evidence supporting vaccine policy failure and its lack of safety is becoming so voluminous that it will eventually destroy the unnatural power alliance that desperately tries to hold it all together.

Read: The Safe Vaccine Debate – 1. The Vaccine Reaction: FluMist Vaccine Approved by CDC Without Proof It Works 2. Children’s Health Defence (Kennedy News & Views): Infant Deaths Following Vaccination: The Numbers Don’t Lie—Or Do They? 3. The Dr Judy Wilyman Report: Newsletter 210 The Fallacy of Doctors being ‘Experts’ in Infectious Disease Control

The Orthomolecular Medicine Organisation is a global organisation concerned with responsible reporting of clinical nutrition – a valid medical science.
Because there is an ability for clinical nutrition to improve health and wellbeing, there exists an opportunity to assist illness through supplementation as well as an ability to replace the more harmful use of drugs, or at minimum, reduce the dose of harmful drugs.
These benefits are often attacked by drug companies because clinical nutrition may represent a more comfortable patient treatment, often accompanied with a lower cost.

Read: OMNS – Arguments for Taking Nutritional Supplements

Trade partnerships tend to serve only the elite.
The very wealthy that try at every opportunity to transfer wealth from any source into their exclusive control.
The treaty that affects Australia in the same way as NAFTA squeezes the US is one with the acronym TPPA – Trans-Pacific Partnership Agreement.
Malcolm Turnbull, before he was deposed, began the process of embedding Australia into the talons of this treaty.
Another example of a politician having his vote “bought” and not doing the job he was elected to do. Turnbull has gone but his legacy lingers on.
Read: Destroy Trump for opposing NAFTA

We conclude our offering for this edition with media releases from two pharmacy leadership organisations:

SHPA – SHPA Media Releases – 1. Pharmacists poised to exert expertise in era of new health challenges 2. New medicines shortages law a big win for members and public 3. Pharmacy World Congress Brisbane-bound in 2021

NPS – NPS Media Releases – CV Risk in Patients With Type 2 Diabetes and CVD – Getting to the Heart of Diabetes

We hope that you enjoy our current content and please join in on any article debate by adding your comment in the panel provided at the foot of each article.

Neil Johnston
Editor, i2P E-Magazine
Monday 1 October 2018

 

 


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