By David Tuller, DrPH

Hey folks! As of now I am at 71% of my goal, with eight days to go. So far I have exactly 700 donations. It would be great to get closer to 1000, as in previous years.

Today, Erica Verillo has generously offered to match any donations made through this Friday–up to a total of $5000. I have so far raised $67,800. So if you’ve been holding off on donating, now’s the time! Make your donation work double! If I raise an additional $5000 more this week, Erica’s $5000 matching gift will bring me much closer to my goal.

It goes without saying that I am very touched and humbled by the enormous support I have already received. Thanks to all who have donated and those who will do so before the end of the crowdfunding! I want to continue to do what I can so that people suffering from this terrible disease finally get the help and care they have always deserved.

Thank you! Here’s the link:

https://crowdfund.berkeley.edu/project/14941

By David Tuller, DrPH

After Reuters ran that PACE/CBT/GET propaganda piece last month, I sent an e-mail expressing two concerns to Kate Kelland, the reporter, and the two editors listed as having worked on the story.

The first concern was that the story falsely said I published my investigation on the blog of a Berkeley colleague. Since Kelland had sent a list of questions about my work to Professor Racaniello, the host of Virology Blog and a Columbia professor, she knew this wasn’t the case. Given that, I assumed the misstatement was an accident–the kind of stupid screw-up that’s really easy to do. All journalists have been there.

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The TWiV team reveals the repertoire of anti-viral antibodies in newborn humans, and a complement protein that binds the adenovirus capsid and prevents release of the viral DNA.

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When we are born, our blood contains antibodies that we have inherited from our mothers. They are transferred across the placenta and provide protection from infection until IgG production begins around 15 weeks after birth. Can we exploit such antibody transfer by vaccinating pregnant mothers to protect newborns against infectious diseases that occur early after birth? At least in mice infected with herpes simplex virus, the answer is yes.

Neonatal infections with herpes simplex viruses, which occur by virus transmission from the mother during childbirth or in the early postnatal period, can have serious consequences, including disseminated disease or encephalitis in half of infected newborns. Even when treated with antiviral drugs, such infections can lead to neurological deficits.

Mothers who have antibodies to herpes simplex viruses are less likely to transmit infections to babies than mothers who have been recently infected. The difference is due to the transfer of maternal IgG antibody to the fetus, which protects against infection. Furthermore, neutralizing antibodies to herpes simplex viruses 1 and 2 are effectively transferred from mother to fetus. In mice, passive transfer of serum from immunized mice to pregnant mice prevented lethal disease after inoculation of pups with herpes simplex virus. These observations suggest that immunization of pregnant women with a herpes simplex virus vaccine might protect offspring from serious infections.

To test this idea, pregnant mice were immunized by intramuscular inoculation with a replication-defective herpes simplex virus 2. Both dams and offspring had antibodies to multiple viral proteins in serum as well as in the trigeminal ganglia – the site of herpes simplex virus latency. When challenged with lethal doses of herpes simplex virus 1 or 2, pups born to immunized dams had reduced virus in the central nervous system and survived. In contrast, pups born to unimmunized dams succumbed to infection.

Because neonatal herpes simplex virus infections can have neurological consequences, mice were subjected to the open field test to measure anxiety-like behavior. Offspring of uninfected dams challenged with a low dose of herpes simplex virus 1 showed thigmotaxis, a tendency to remain close to the walls of the mouse cage. In contrast, offspring of infected dams showed normal behavior after infection. These observations show that even a low dose of herpes simplex virus can cause abnormal behavior in mice, which can be prevented by immunization of dams.

These findings suggest that other neonatal infectious diseases, which occur too early in life to be stopped by immunization, might be prevented by immunizing the pregnant mother. Besides herpes simplex virus infections, acquired at birth or shortly thereafter, this approach might also be applicable to prevent respiratory syncytial virus infections, which typically occur in the first few months of life. In addition, maternal immunization against viruses acquired in utero by transplacental passage of virus from mother to fetus – including cytomegalovirus and Zika virus – might also be of benefit to the fetus.

As the authors write, the maternal virome is likely an important determinant of human health. Thanks, Mom.

[For more discussion of this paper, listen to Immune #19]

By David Tuller, DrPH

Last Sunday, I sent a letter expressing my concerns about Kate Kelland’s recent article to the appropriate person–the Reuters global editor for ethics and standards. After considering the issues, Reuters has decided to add my current academic title to the post and leave everything else as is. I appreciate the first decision and obviously disagree strongly with the second.

I note that the story still refers to me, for some reason, as a “former journalist.” This is false. I am both a currently working journalist and a public health investigator. For some reason, Reuters has determined it is impossible to be both.

I might have more to say about this going forward. For now, I’m posting the letter I sent. (In the actual e-mail, I linked to everything; I didn’t bother to do that here.)

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By David Tuller, DrPH

As of this post, I have achieved 57% of my goal, with 542 donations and 15 days left to go. I think that’s pretty good! I’m optimistic about getting reasonably close to the amount I’m trying to raise. Folks at Berkeley certainly notice the success of my crowdfunding. It is an unusual way for academics to support their positions, but from the university’s perspective I’m doing what academics are supposed to do—bring in money.

The UK continues to dominate, with 206 donations, followed by the US with 107, Norway with 64, Australia with 40, Sweden with 26 and Canada with 22. Six people donated from New Zealand, where I’m planning to go later this year. Last year I received around 1000 donations, so there still seems room to grow!

Here’s the link: https://crowdfund.berkeley.edu/project/14941

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Oxford psychiatrist Michael Sharpe doesn’t seem to be able to stop himself from sending silly letters to publishers about something they have published that he doesn’t like. Earlier this year, I reported on his efforts to have two excellent stories retracted–one each by my friends and colleagues Julie Rehmeyer and Steven Lubet. (Disclosure: I have co-written articles with both of them.) Professor Sharpe’s letters were somewhat incoherent. They included untrue accusations and represented—to me—his inability to break free from the vicious cycle of self-serving argumentation in which he appears to have been trapped for decades. Sad.

Earlier this month, Annals of Internal Medicine published an editorial by Peter Rowe, a pediatrician at Johns Hopkins, about the null findings from the Norwegian rituximab study. In this editorial, Professor Rowe had the temerity to cite last year’s PACE reanalysis (Wilshire et al, of which I was a co-author) and suggest that the investigators’ own reported findings in The Lancet and elsewhere had essentially been debunked.

Professor Sharpe, of course, was not one to let this pass. In his published response, he accused Professor Rowe of drawing “a nihilistic conclusion about treatment options” and wrote this:

“Dr Rowe…dismisses the findings of this trial [PACE], referencing a critique published in the journal BMC Psychology and implying that this had nullified the trial findings. This is not the case. This critique, the authors of which included campaigners against any psychologically informed approach to the treatment of ME or CFS, has been rebutted by the PACE authors. Furthermore the main PACE trial of a useful benefit from CBT and GET have been repeatedly replicated.

Finally, it is surely unfair to patients to casually dismiss the evidence for an approach that could help them, simply because campaigners reject any treatment that could be seen as “psychological.” Surely, the people who suffer from this condition deserve accurate information about, and access to, all treatments for which there is good evidence of efficacy, whether these treatments are psychologically informed, or not. ”

As usual, this is nonsense. There is nothing “nihilistic” about pointing out the truth–the CBT/GET paradigm has been effectively discredited, whether Professor Sharpe chooses to acknowledge that or not. He dismisses the Wilshire reanalysis on the grounds that the group of authors “included campaigners against any psychologically informed approach to the treatment of ME or CFS.” But it is false to claim that those opposing PACE and the CBT/GET paradigm are motivated mainly by antipathy to psychologically informed approaches to anything. They are motivated by antipathy to bad science, of which PACE is a shining example.

Professor Sharpe further notes that he and his colleagues have “rebutted” Wilshire et al. Poor, deluded Professor Sharpe. He believes that just because he and his colleagues construct some sentences and publish them in a professional venue, it constitutes an effective “rebuttal.” He is mistaken. The “rebuttal” to Wilshire et al, like every rebuttal ever issued by the PACE authors, cannot be taken seriously. It is a mish-mash of their previous inadequate and unconvincing arguments. It will not quell the momentum of this ongoing paradigm shift in how ME/CFS is viewed, researched and treated.

In a telling moment in Sharpe’s response to Rowe, he cites the recent article written by Kate Kelland, a Reuters science reporter as well as the provider of glowing testimonials for the Science Media Centre’s public relations efforts. Let’s parse this. Professor Sharpe tells Kelland that “campaigners” reject any research that suggests the illness might have a psychological component. Then he references the resulting propaganda piece as evidence that “campaigners” reject any research that suggests the illness might have a psychological component.

This is the kind of rhetorical juju that the CBT/GET ideological brigades have successfully deployed in maintaining their hegemony all these years. Now that the peer-reviewed literature includes robust refutation of the bogus claims from PACE, these arguments don’t seem to work for them as well anymore.

I look forward to Rowe’s response.

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Professor Trudie Chalder has also been keeping herself busy. With several co-authors, she is out with yet another paper promoting the value of her much-loved CBT—this time for patients suffering from irritable bowel syndrome. This study shares PACE’s fundamental problem—it’s an open label trial relying on subjective outcomes. The findings will therefore be infused with an unknown amount of bias. So, you know, trust the results at your own risk. Do these people never tire of foisting this stuff on the public?

There’s been some discussion of the study on this thread on the Science For ME forum.

News coverage of the study was predictably unskeptical, with headlines to match. “Answer to irritable bowel syndrome is in the mind,” declared The Daily Telegraph on its front page. According to the headline in The Daily Mail, “Talking therapy could cure IBS better than drugs, study reveals…” The Guardian article included the following paragraphs:

“While the team said they are still investigating quite why CBT helps, they noted the therapy was tailored specifically to IBS and, among its features, offered participants information on how the bowel works, practical advice on eating and exercise, and ways to manage stress, sleep and emotions. 

It also included ways to break patterns of unhelpful behaviours and thoughts, such as people with diarrhoea immediately dashing to the toilet if they felt the urge, or people waking up with stomach problems and therefore assuming the day would be difficult.”

Hm. This “therapy” seems to be trying to do lots of different things at once. I’m not sure how the investigators could possibly tease out which factor would account for whatever improvements they’ve observed. Practical advice on eating or stress reduction training could conceivably help patients cope with IBS and boost their self-reported outcomes while having little to do with the provision of CBT. Moreover, if The Guardian is right and the investigators were telling people who were about to have an explosive expulsion event that they should avoid rushing to the toilet…well, let’s just say I’m glad no one taking part in this study was living in my house.

IBS is, of course, one of those conditions that falls into the catch-all-category of “medically unexplained symptoms.” That’s the category that includes everything that Chalder, Sharpe, Wessely and their acolytes cannot explain physiologically. And if Chalder, Sharpe, Wessely and their acolytes cannot explain something physiologically, it must be amenable to psychological and behavioral interventions.

This is, more or less, the simplistic framework for the metastasizing National Health Service program called Improving Access to Psychological Therapies, or IAPT. I have written about this program before and will do so again. “Chronic fatigue syndrome” has regularly been lumped among the conditions falling within the MUS grouping, which are targeted for treatment through IAPT. The PACE trial has thus served as something of a template or “proof-of-concept” for this effort to ramp up delivery of these kinds of psychologically oriented services.

Citing PACE has become a bit more problematic recently, since the literature now includes a convincing, peer-reviewed refutation of all the main PACE findings. The CBT/GET ideological brigades are undoubtedly eager to replicate that initial success and promote varieties of these therapies for other illnesses, like IBS, that they believe are characterized by cognitions that need changing.

Sure enough, a press release about the study includes an interesting quote from Professor Chalder’s colleague and collaborator on the study, Professor Rona Moss-Morris. Here’s what she had to say:

“The most important next step is for these tailored CBT treatments to be made more widely available. Professor Trudie Chalder and I are currently training NHS therapists at pre-existing Improving Access to Psychological Therapy (IAPT) services, so that more people suffering from IBS can access these treatments quickly. We are also working with a commercial partner to bring web-based CBT to the NHS and other parts of the world.”

Wow, that didn’t take long. Bet those “other parts of the world” can’t wait!

The TWiV team discusses Medusavirus, isolated from a hot spring in Japan, and induction of neurodegeneration by recurrent herpes simplex virus 1 infection of mice.

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Show notes at microbe.tv/twiv

by Gertrud U. Rey

In 1998, a British doctor named Andrew Wakefield published a paper in the British journal The Lancet. In this paper, Wakefield implied that the measles, mumps, and rubella (MMR) vaccine may cause developmental disorders such as autism spectrum disorder (ASD). The paper received wide publicity, and subsequently, MMR vaccination rates began to decline, triggering the current anti-vaccine movement and the re-emergence of previously controlled diseases.

Since this unfortunate event, many scientific studies, articles, editorials, and books have been published that totally discredit a causative link between vaccination and ASD. Pediatrician and vaccine scientist Peter Hotez also published a book on this topic, titled Vaccines did not Cause Rachel’s Autism. Hotez’s book has a slightly different angle because “Rachel” happens to be his daughter.

In the book, Hotez goes into excruciating detail about the challenges and personal drama involved with raising an autistic child and living with an adult daughter with ASD. The book is unique because it blends a personal story from the perspective of an autism dad, with solid, systematic, and comprehensive science.

In 2013, the American Academy of Pediatrics published a 21-page document listing the accumulated scientific evidence that there is no causal link between vaccines and ASD. The epidemiological studies listed in this document and additional studies published since then, disprove all of the inaccurate theories and speculations that gained support in the years following Wakefield. Specifically, they show that:

• There is no link between any side effects from vaccination (such as temporary fever) and ASD.
• The preservative thimerosal (ethylmercury) in multi-dose vials of pediatric vaccines does not cause ASD. Additionally, the rates of autism have continued to increase, even though thimerosal was removed from all childhood vaccines in 2001 (solely as a precautionary measure).
• Aluminum (an ingredient that enhances the immune response) in vaccines does not cause ASD.
• Administering vaccines closely together does not cause ASD. The idea of “antigenic overload” (i.e., too many vaccines in a short time frame) disregards the fact that an infant’s immune system is bombarded with dozens or hundreds of new antigens every day.
• Vaccines do not cause autoimmune disorders.

In short, every single study aiming to verify a causal link between vaccination and ASD to this date has found no such link. It is important to note that the American Academy of Pediatrics is not connected to the US government, thus invalidating any claims that this document is motivated by an alleged government conspiracy.

Hotez stresses that these epidemiological studies were carried out under carefully controlled conditions and collectively involved more than one million children. In contrast, Wakefield’s study lacked a proper control group and involved twelve children who had been specifically selected because their medical background fit a preconceived idea. In addition, Wakefield manipulated the data, failed to declare multiple financial conflicts of interest, and committed other forms of serious professional misconduct. By 2004, ten of his twelve co-authors retracted their authorship, stating that their initial interpretation of the data was incorrect and that there is no causal link between vaccination and ASD. By 2010, The Lancet retracted the paper and the editor apologetically admitted that the study’s conclusions were highly inaccurate.

Having dealt with the hurdles of drug development his entire career, Hotez describes how difficult it is to obtain FDA approval for any given vaccine formulation. The process takes at least a decade and during this time, the necessity of each ingredient has to be justified and its safety proven. Even once a vaccine is approved for public use, its safety is continually monitored through post-market safety surveillance and the Vaccine Adverse Event Reporting System. The policies in place to ensure the safety of vaccines are exhaustive and redundant.

That being said, vaccine adverse events can happen. However, considering the large number of vaccines administered in the United States every year, these instances are so rare that according to the National Vaccine Injury Compensation Program, the likelihood of a person sustaining a severe injury from a vaccine is about 1 in 1,000,000. For perspective, the likelihood of being struck by lightning in any one year, is much greater (1 in 700,000).

Hotez also offers plenty of evidence for what does cause ASD. While scientists have not identified one specific cause, evidence suggests a strong genetic basis, with mutations in up to 1000 genes linked to a characteristic overgrowth of the prefrontal cortex and temporal lobe of the brain. This overgrowth is initiated at least a year before onset of symptoms, and hence, well before vaccination. We also know that environmental factors and/or changes in gene regulation (epigenetics) play a strong causative role and that the processes leading to an ultimate ASD diagnosis begin in the womb. Interestingly, the most convincing environmental cause of ASD is congenital rubella syndrome, thereby ironically suggesting that MMR vaccination actually prevents ASD.

Anti-vaccine advocates often assert that our body’s natural immunity is adequate to overcome common childhood infections and that natural infection with a disease like measles strengthens the immune system. In fact, the opposite is true. Almost a million unvaccinated children die from vaccine-preventable diseases each year. In the years following the eradication of smallpox, measles in particular was the single leading killer of children, with two million children dying of measles every year. Even when it doesn’t kill, measles encephalitis and pneumonia can cause permanent injury and absolutely devastate the immune system.

Science is a self-correcting process and any seminal discovery or causative claim of high public interest will be scrutinized by the scientific community ad nauseam. The claim for a causal relationship between vaccination and ASD is possibly the most thoroughly scrutinized claim in all of biomedical science. And the conclusions are clear and unambiguous.

Unfortunately, Wakefield’s claims gained quick momentum, giving rise to an ideology that is continually amplified and perpetuated by his followers. Today, the anti-vaccine movement is a well-funded and well-organized lobby with more than 400 websites that are backed by political action committees, social media, and poorly informed celebrities with loud voices. The resultant return of vaccine-preventable diseases and their effect on public health is alarming, to say the least. Peter Hotez actively advocates for vaccination by regularly and publicly denouncing anti-vaccine claims and by promoting the safety and necessity of vaccination through a variety of media outlets. However, there is an imminent need for additional prominent scientists, public health leaders and politicians to join him in this endeavor.

[Peter Hotez was a guest on a special episode of TWiV, which aired on December 19, 2018]

By David Tuller, DrPH

Last month I wrote to the director of legal services at the University of Bristol seeking information about documents from a study conducted by investigators from the institution. The study, published by BMJ Open in 2011, was called “Unidentified Chronic Fatigue Syndrome/myalgic encephalomyelitis (CFS/ME) is a major cause of school absence: surveillance outcomes from school-based clinics.”

More than a year ago, I had sought consent forms and other documents from Bristol through a freedom of information request. In response, Bristol noted that this was a “pilot clinical service” and “a clinical project” and that the university held none of the study documents. Yet the specialist service for pediatric CFS/ME in Bath, the medical unit that ran the “clinical project,” also informed me that it did not hold the documents and suggested I needed to contact the university.

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