Tag: EMA

Crisis at the Nordic Cochrane Centre

This could be it for the Nordic Cochrane Centre.

“I regret to inform you that I have been expelled from membership in the Cochrane Collaboration by the favourable vote of 6 of the 13 members of the Governing Board. No clear reasoned justification has been given for my expulsion aside from accusing me of causing “disrepute” for the organization.”

Peter Gøtzsche on A moral governance crisis: the growing lack of democratic collaboration and scientific pluralism in Cochrane

Or at least for Peter Gøtzsche and his association with the Cochrane Collaboration, which he co-founded in 1993.

I’m not sure how he thinks that there was no clear justification for his being expelled though.

Crisis at the Nordic Cochrane Centre

Most folks understand why Peter Gøtzsche was expelled from the Cochrane Collaboration…

They remember that he recently published a poorly done analysis in BMJ Evidence-Based Medicine, The Cochrane HPV vaccine review was incomplete and ignored important evidence of bias that was critical of a Cochrane Review on the HPV vaccine, Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors, which concluded that the HPV vaccines work and that they are safe.

While Gøtzsche’s analysis prompted the Cochrane Collaboration to initiate an investigation, they concluded that his analysis “substantially overstated its criticisms” and that the allegations were “not warranted and provided an inaccurate and sensationalized report of their analysis.”

Is that it?

Nope.

Many people are also familiar with the Nordic Cochrane Centre because of their involvement in continued complaints about the HPV vaccine. Complaints that were not approved by the Cochrane Collaboration and that were not an official Cochrane viewpoint!

“…we highlight here how academic colleagues, under the purported banner of a respected authority, raise concerns about the HPV vaccine but they cite an evidence base of small and poor quality studies and ignore the extensive wealth of global literature that vividly demonstrate the excellent efficacy and safety record of the vaccine.”

Head et al on Inadvisable anti-vaccination sentiment: Human Papilloma Virus immunisation falsely under the microscope

Complaints that had already been investigated and dismissed by the European Medicines Agency and refuted by many other studies.

“This week at its meeting in Edinburgh, Cochrane’s Governing Board considered, as planned, the findings of an independent review and additional complaints related to the conduct of a Member. The Board’s conclusion was communicated to the individual concerned and is part of an ongoing process. The Co-Chairs of the Board will provide further details once this process is complete.

Following this, four Board members (Gerald Gartlehner, David Hammerstein Mintz, Joerg Meerpohl and Nancy Santesso) decided to resign as Cochrane trustees with immediate effect.”

Message from the Governing Board

Unfortunately, Gøtzsche’s being expelled led to others leaving the Cochrane Governing Board, including two appointed trustees who volunteered to step down to to comply with Cochrane’s Articles of Association.

Although they may not have been defending Gøtzsche's opinions or behaviors, four other board members resigned in solidarity.
Although they may not have been defending Gøtzsche’s opinions or behaviors, four other board members resigned in solidarity.

We can hope that this is the end of the matter, as Cochrane will soon have an election for new board members.

Peter Gøtzsche is out at the Cochrane Collaboration.
Peter Gøtzsche is out at the Cochrane Collaboration.

Will he be kept on at the Nordic Cochrane Centre, which he founded? Will the Nordic Cochrane Centre be allowed to keep ‘Cochrane’ in their name?

The Nordic Cochrane Centre is primarily funded by the Danish Government, and what do they get besides all of the anti-HPV vaccine stuff?

“Antidepressant drugs are another major killer that people could do well without.”

Peter C Gøtzsche: Prescription drugs are the third leading cause of death

Peter Gøtzsche seems to be against cancer screening, psychiatric drugs, and thinks that Big Pharma has corrupted health care. Is that the “plurality of opinions, views, and perspectives” that folks want at Cochrane or anywhere else in medicine?

Unfortunately, I bet this isn’t the last that we have heard from him.

More on the Crisis at the Nordic Cochrane Centre

Can Vaccines Cause POTS?

Have you ever heard of POTS?

“In POTS, the lightheadedness or fainting is also accompanied by a rapid increase in heartbeat of more than 30 beats per minute, or a heart rate that exceeds 120 beats per minute, within 10 minutes of rising.”

NIH Postural Tachycardia Syndrome Information Page

POTS or postural orthostatic tachycardia syndrome was first identified in the early 1990s and can cause many debilitating symptoms, such as dizziness, headaches, and fatigue.

What Causes POTS?

We don’t know what causes POTS.

“The term “POTS” was coined in 1993 by a team of researchers from Mayo Clinic, led by neurologist Dr. Philip Low. However, POTS is not a new illness; it has been known by other names throughout history, such as DaCosta’s Syndrome, Soldier’s Heart, Mitral Valve Prolapse Syndrome, Neurocirculatory Asthenia, Chronic Orthostatic Intolerance, Orthostatic Tachycardia and Postural Tachycardia Syndrome.”

Dysautonomia International on POTS

Well, we know that POTS is caused by a malfunction of the patient’s autonomic nervous system (dysautonomia), but we don’t know always know what causes or triggers that malfunction.

Sometimes we do though, as POTS has been associated with other types of dysautonomia, like Ehlers-Danlos Syndrome and Mast Cell Disorders.

And genetics may play a role in some people with POTS.

Can Vaccines Cause POTS?

It shouldn’t be surprising that some folks think that vaccines could be associated with POTS.

“Anyone at any age can develop POTS, but the majority of individuals affected (between 75 and 80 percent) are women between the ages of 15 to 50 years of age.”

NIH Postural Tachycardia Syndrome Information Page

That’s right.

As more people were becoming aware of POTS, some of them were getting vaccinated for HPV.

But that correlation certainly doesn’t mean that vaccines cause POTS.

“POTS is a condition that causes lightheadedness or fainting and a rapid increase in heartbeat upon standing. The cause is unknown, but doctors think POTS may be associated with a number of risk factors and syndromes, including: a recent viral illness, physical deconditioning, chronic fatigue syndrome and nervous system problems.”

CDC on Can HPV vaccines cause POTS?

And studies have confirmed that, including:

  • In 2015, the European Medical Association confirmed evidence that HPV vaccines do not cause complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS)
  • A review of VAERS reports that “did not detect any unusual or unexpected reporting patterns that would suggest a safety problem” with HPV vaccination, including extra cases of POTS
  • A study in the UK using the MHRA’s Yellow Card passive surveillance scheme found no increase in reports of chronic fatigue syndromes following the introduction of Cervarix
  • A large, nationwide register-based study from Norway found no indication of increased risk of chronic fatigue syndrome/myalgic encephalomyelitis following HPV vaccination
  • A large cohort study of over 2 million young girls in France found no risk for autoimmune diseases (including neurological, rheumatological, hematological, endocrine, and gastro-intestinal disorders)
  • A large cohort study of girls in Sweden with pre-existing autoimmune diseases found that HPV vaccination was not associated with increased incidence of new-onset autoimmune disease (49 types of autoimmune diseases)

Contrast those large studies that are evidence against any association between vaccines and POTS with the case reports, anecdotal evidence, and vaccine scare stories that say there is.

“There is currently no conclusive evidence to support a causal relationship between the HPV vaccine and POTS. It is of utmost importance to recognize that although temporal associations may be observed, conclusions of causality cannot be drawn from case reports and case series due to the small sample size and lack of control population inherent to this type of scientific literature. If POTS does develop after receiving the HPV vaccine, it would appear to do so in a small subset of individuals and would be difficult to distinguish from the normal prevalence and incidence of the disorder.”

Butts et al on Human Papillomavirus Vaccine and Postural Orthostatic Tachycardia Syndrome: A Review of Current Literature

What about other vaccines? Could they cause POTS?

Folks should remember that a case report is basically a gloried anecdote and is not the kind of evidence you should use to make decisions about vaccinating and protecting your kids.
Folks should remember that a case report is basically a gloried anecdote and is not the kind of evidence you should use to make decisions about vaccinating and protecting your kids.

While the focus has been on the HPV vaccines, an issue with other vaccines causing POTS would have been picked up with our current vaccine safety systems.

But why has the focus been on the HPV vaccines?

It is an easy association to notice, after all POTS begins to occur right around when the HPV vaccines are given (teen years) and the HPV vaccines are given in many different countries. Most other vaccines that we give to teens in the United States, including Tdap and the meningococcal vaccines, aren’t as widely used in other countries.

But remember, POTS isn’t a new diagnosis. That anti-vaccine groups are latching onto it to scare parents away from vaccinating and protecting their kids is.

What to Know About Vaccines and POTS

There is no evidence that vaccines, especially the HPV vaccines, cause POTS.

More on Vaccines and POTS