Daily Archives: April 25, 2022

Ive long lamented a certain blind spot among my fellow physicians and scientists, a problem that the COVID-19 pandemic has made even more painfully apparent to me. What Im referring to is our inability as a group to recognize when science is being distorted and thereby weaponized in order to become disinformation. This is not a new technique, but its been turbocharged and used more frequently and intensely than ever before. I was reminded of this by a recent Twitter thread, the first part of which I will cite here:

Naturally, antivaxxers have been spreading this study far and wide as yet more evidence that mRNA vaccines against COVID-19 are dangerous:

I could list many more such Tweets, as well as the study being shared this way on Facebook with similar messaging that its strong evidence that mRNA vaccines are dangerous and suppress the innate immune system, the spike protein is toxic, and large numbers of people are being harmed by themexactly as intended by the antivaxxers who wrote it. But is it evidence of any of this? I think that you know the answer. Rather, it is a prime example of what I now refer to as misinformation (or disinformation) by scientific review article (or, more accurately, a pseudo-review article). It appears to have all the trappings of science, but its speculation goes far beyond what the science will support, all in the service of promoting a certain narrative and providing what seems to be scientific support for a pseudoscientific conspiracy theory. Unsurprisingly, it worked, as its social media engagement demonstrates.

It is also true that Prof. Morris nailed it perfectly in the fourth Tweet in his series. This review article is almost entirely speculative. However, not having such a long history of examining antivaccine pseudoscience, he missed observing that the article is speculative in a deceptive manner that Ive seen many times before dating back to the Hannah Poling story in 2008, in which antivaxxers tried to rebrand autism as a mitochondrial disorder in which vaccines interacted with a metabolic disease to trigger autism, a narrative that functional medicine guru Dr. Mark Hyman echoed and that was still being promoted up to right before the pandemic. As a preview, Ill mention that other examples include Yehuda Shoenfelds ASIA diagnosis, the idea of molecular mimicry by HPV vaccines, and homologous recombinaltion tiniker (misspelling preserved from the original). Think of this long review as a Gish gallop disguised as a review article. There are lots of claims, all speculative, many for which the cited evidence is at best tenuous and often requires quite the leap to go from what the evidence finds about a process and how that process might be related to COVID-19 vaccination.

Combined with the speculative claims about biological mechanism is also an exercise in dumpster diving into the Vaccine Adverse Events Reporting System (VAERS) database in a manner very much like how Tracy Beth Heg and other COVID-19 contrarians did for myocarditis last summer in an echo of how Mark and David Geier did it 16 years ago trying to prove that mercury in the thimerosal preservative that was used in some childhood vaccines until around 2001-2 caused autism, other antivaxxers tried to link the H1N1 vaccine to miscarriages (sound familiar?), and how Stephanie Seneff used the same deceptive technique to try to demonstrate in 2012 that aluminum adjuvants in vaccines and exposure to acetaminophen caused autism. Since COVID-19 vaccines hit the scene in December 2020, weaponization of VAERS reports has been a constant among antivaxxers.

The last name I mentioned is important. Why? Because Stephanie Seneff is the lead author of the paper thats been going around. She was an antivaxxer before the pandemic who blamed vaccines and GMOs for autism; its not surprising that she pivoted to being anti-COVID-19 vaccines, although early in the pandemic she tried to blame glyphosate and e-cigarettes for COVID-19. (I kid you not.) Like many antivaxxers before and during the pandemic, she has no primary expertise in vaccines, infectious disease, public health, epidemiology, or any other relevant biomedical academic disciplines. Rather, shes a computer scientist at MIT, and her sole qualification (if you can call it that) is an undergraduate biophysics degree from the late 1960s. In addition to her history promoting antivaccine misinformation, she has also made some truly off-base proclamations over the last several years, including her prediction in 2014 that by 2025 half of all children born that year will be autistic. (Its 2022 now. Howd that prediction work out?) She even once claimed that GMOs can cause concussions.

Weve also met Peter McCullough before. Hes a cardiologist who has been promoting a narrative that COVID-19 vaccines are causing a holocaust for over a year now. Unsurprisingly, hes also promoted ivermectin as a near miracle cure for COVID-19. Basically, Dr. McCullough has become a major force in promoting COVID-19 pseudoscience, quackery, and misinformation and is frequently on the speakers list for COVID-19 denial rallies and events.

I was interested in the other two authors, Greg Nigh and Anthony Kyriakopoulous, as I didnt recall having heard of them before. Greg Nigh is listed as being affiliated with Immersion Health in Portland, OR. Surprise! Surprise! Immersion Health is a naturopathic oncology clinic:

Immersion Health opened its doors in 2014. Dr. Greg Nigh and Maria Zilka, the clinics founders, have collaborated on cancer treatment for 10 years. Immersion Health brings them together to offer intensive, comprehensive and individualized programs for the treatment of all types and stages of cancer. In addition to cancer care, Dr. Nigh offers the full range of primary care medicine, including functional lab testing and genetic polymorphism analysis.

Immersion Health was started as an intensive naturopathic oncology clinic. Dr. Nigh develops comprehensive and intensive treatment programs for all types and stages of cancer.

The cancer treatment approach at Immersion Health is unique, recognizing cancer as a metabolic disease. At Immersion Health we are delivering therapies that address all aspects of health and vitality, because long-term success against cancer depends on a strong immune system, low inflammation, ongoing detoxification, lifelong nutritional strategies, stress management, physical activity and much more. Immersion Health brings this all together into individualized treatment plans that optimize every individuals potential for recovery and ongoing wellness.

Naturopathy is quackery, and naturopathic oncology doubly so. Just peruse this blog for many, many examples. Unsurprisingly, naturopaths have pivoted to COVID-19 quackery. Of the group, Anthony Kyriakopoulous has the closest to what one might consider actual qualifications, working at the Nasco AD Biotechnology Laboratory, a lab in Greece described as a private research laboratory focusing on the discovery, development and thereafter clinical application of patented medicinal formulations to provide innovative technology against infections inflammation autoimmunity and cancer. He also appears to have some expertise in RNAs and inflammation, but, as I always say, if youre an expert in something but associate your name with cranks, quacks, and pseudoscientists like Stephanie Seneff, Peter McCullough, and Greg Nigh, that should be a major red flag that perhaps the expert has gone crank.

Of course, defenders of authors like these would call what I just wrote an ad hominem attack. Its not, really. It could be an ad hominem attack if the only reason I gave for their paper being wrong were because it was authored by them, but you know me better than that. My response to such a charge is always the same: Qualifications matter. Author history matters. All but one of the authors are utterly unqualified to write a review article like this, and the one who arguably does have some qualifications is not the first author or the corresponding author. That tells me a lot before I read beyond the abstract.

Finally, this is a long article. Thats why, unlike Prof. Morris, Im going to approach it more from the angle of disinformation and its similarities to previous papers like it before the pandemic than get into the weeds of each and every claim, especially given that he has provided a good blog post that does get into the weeds, some of which I will borrow from given that its impossible not to address some claims. Again, Prof. Morris was quite correct that the paper is largely speculative and doesnt cite a lot of primary evidence, but that very speculativeness is a hallmark of many prior antivax narratives that try to postulate a biological mechanism by which vaccines caused autism and all manner of other health issues dating way, way back. Similarly, the paper does a VAERS dumpster dive to try to lend credibility to its speculation.

One of the more interesting things, from a disinformation standpoint, is a figure right at the beginning of the review, described as a graphical abstract. When I first read the paper, I hadnt recalled seeing such a figure described thusly, but I did recall a number of figures from the past in which vaccines were inserted into metabolic and immune pathways to make a science-y looking diagram arguing how vaccines caused this problem or other. Lets take a look:

This graphical abstract looks so very, very scientific, doesnt it?

Lets look at the actual written abstract and compare:

The mRNA SARS-CoV-2 vaccines were brought to market in response to the public health crises of Covid-19. The utilization of mRNA vaccines in the context of infectious disease has no precedent. The many alterations in the vaccine mRNA hide the mRNA from cellular defenses and promote a longer biological half-life and high production of spike protein. However, the immune response to the vaccine is very different from that to a SARS-CoV-2 infection. In this paper, we present evidence that vaccination induces a profound impairment in type I interferon signaling, which has diverse adverse consequences to human health. Immune cells that have taken up the vaccine nanoparticles release into circulation large numbers of exosomes containing spike protein along with critical microRNAs that induce a signaling response in recipient cells at distant sites. We also identify potential profound disturbances in regulatory control of protein synthesis and cancer surveillance. These disturbances potentially have a causal link to neurodegenerative disease, myocarditis, immune thrombocytopenia, Bells palsy, liver disease, impaired adaptive immunity, impaired DNA damage response and tumorigenesis. We show evidence from the VAERS database supporting our hypothesis. We believe a comprehensive risk/benefit assessment of the mRNA vaccines questions them as positive contributors to public health.

I will concede that the immune response to the vaccine is likely different than the immune response to a SARS-CoV-2 infection, but not in the way described in this paper that implies that its just as bad or worse than the immune reaction to infection. The authors claim that the mRNA vaccine initiates a set of biological events that are not only different from that induced by infection but are in several ways demonstrably counterproductive to both short- and long-term immune competence and normal cellular function but, as Prof, Morris notes, they self-cite to do it:

A preprint has revealed a remarkable difference between the characteristics of the immune response to an infection with SARS-CoV-2 as compared with the immune response to an mRNA vaccine against COVID-19 (Ivanova et al., 2021).

Where does that link go? Straight back to this review article! (If you dont believe me and think that I altered the link, just go to the article itself and click on the link.) The actual paper is a preprint from August that appears to be still a preprint, and the interesting thing about it is that the paper demonstrates a good thing about COVID-19 mRNA vaccines, namely:

In COVID-19 patients, immune responses were characterized by a highly augmented interferon response which was largely absent in vaccine recipients. Increased interferon signaling likely contributed to the dramatic upregulation of cytotoxic genes in the peripheral T cells and innate- like lymphocytes observed in COVID-19 patients. Analysis of B and T cell repertoires revealed that while the majority of clonal lymphocytes in COVID-19 patients were effector cells, in vaccine recipients clonal expansion was primarily restricted to circulating memory cells. Taken together, our analysis of immune responses to the mRNA vaccine reveals that despite the lack of dramatic inflammation observed during infection, the vaccine elicits a robust adaptive immune response.

Then Seneff et al. also claim:

All of these observations are consistent with the idea that the anti-COVID-19 vaccines actively suppress type I IFN signaling, as we will discuss below.

More likely, its consistent with the vaccines not stimulating type I IFN signaling and all the inflammation that comes with it, which is a good thing. After all, thats what you want from a vaccine: a robust immune response that doesnt come with all the inflammation caused by the infection but still ends up producing memory cells that can be reactivated by contact with the provoking antigen! After all, the main issue is that actual infection is, well, infection. It stimulates the immune response as the virus is replicating freely and damaging cells, thus leading to inflammation, both specific to the infection and nonspecific. Also, the mRNA vaccines induce muscle cells to make the SARS-CoV-2 spike protein, which is the protein that binds to the ACE2 receptor on human cells and allows the virus to enter them. Thats the target of the immune response. Infection would be expected to result in an immune response to more viral proteins than just the spike protein.

Just the introduction is full of additional misrepresentations, for example:

Since long-term pre-clinical and Phase I safety trials were combined with Phase II trials, then phase II and III trials were combined (Kwok, 2021); and since even those were terminated early and placebo arms given the injections, we look to the pharmacosurveillance system and published reports for safety signals. In doing so, we find that that evidence is not encouraging. The biological response to mRNA vaccination as it is currently employed is demonstrably not similar to natural infection. In this paper we will illustrate those differences, and we will describe the immunological and pathological processes we expect are being initiated by mRNA vaccination. We will connect these underlying physiological effects with both realized and yet-to-be-observed morbidities. We anticipate that implementation of booster vaccinations on a wide scale will amplify all of these problems.

This is a deceptive misrepresentation of what actually happened, something I wrote about over a year ago. Basically, once the vaccines were released under an emergency use authorization (EUA), there was no way to guarantee that subjects in the placebo arm of the large clinical trials carried out by Pfizer and Moderna for their vaccines would not simply get vaccinated. After all, the EUA had been issued, and doctors and the government were doing everything they could to encourage people to be vaccinated against COVID-19. The unblinding and crossover of the clinical trials was actually the ethical thing to do, even if it complicated the long term safety surveillance. Once a vaccine demonstrated to be effective and safe has been released to the public, regardless of the regulatory mechanism under which it was approved, it was, quite simply, unethical to continue to withhold the vaccine from the subjects in the placebo group. This is an issue that antivaxxers and those who enable them have long distorted; so its not at all surprising that Seneff et al. are doing it too.

They also parrot a number of common anti-COVID-19 vaccine talking points that Ive discussed both here and at my not-so-super-secret other blog:

The mRNA vaccines manufactured by Pfizer/BioNTech and Moderna have been viewed as an essential aspect of our efforts to control the spread of COVID-19. Countries around the globe have been aggressively promoting massive vaccination programs with the hope that such efforts might finally curtail the ongoing pandemic and restore normalcy. Governments are reticent to consider the possibility that these injections might cause harm in unexpected ways, and especially that such harm might even surpass the benefits achieved in protection from severe disease. It is now clear that the antibodies induced by the vaccines fade in as little as 310 weeks after the second dose (Shrotri et al., 2021), such that people are being advised to seek booster shots at regular intervals (Centers for Disease Control and Prevention, 2021b). It has also become apparent that rapidly emerging variants such as the Delta and now the Omicron strain are showing resistance to the antibodies induced by the vaccines, through mutations in the spike protein (Yahi et al., 2021). Furthermore, it has become clear that the vaccines do not prevent transmission of the disease, but can only be claimed to reduce symptom severity (Kampf, 2021a). A study comparing vaccination rates with COVID-19 infection rates across 68 countries and 2947 counties in the United States in early September 2021, found no correlation between the two, suggesting that these vaccines do not protect from spread of the disease (Subramanian and Kumar, 2947). Regarding symptom severity, even this aspect is beginning to be in doubt, as demonstrated by an outbreak in an Israeli hospital that led to the death of five fully vaccinated hospital patients (Shitrit et al., 2021). Similarly, Brosh-Nissimov et al. (2021) reported that 34/152 (22%) of fully vaccinated patients among 17 Israeli hospitals died of COVID-19.

Note the appeal to natural immunity (more properly called postinfection immunity or infection-induced immunity) above all, even though evidence is increasingly showing that natural immunity wanes as well and likely doesnt last much longer than vaccine-induced immunity. Moreover, the rise of the very variants that can evade prior immunity (Delta and Omicron) demonstrates that natural immunity can be bypassed by the virus almost as easily as vaccine-induced immunity. In addition, as any immunologist knows, antibody levels dont stay high forever after an infection or a vaccine. If that were the case, our blood would soon become a viscous glop of nothing but high levels of antibodies to previously-encountered antigens to which the immune system had responded. Its the development of memory cells, which can quickly be reactivated to produce antibodies when the immune system encounters an antigen again, that matter more. As for disease transmission, once again we see the Nirvana fallacy, in which anything less than 100% safety and efficacy implies that a treatment or vaccine is worthless, in this case that the vaccine doesnt prevent transmission. Actually, it does; its just not 100% effective and the effect, like that of the vaccine, does wane. The way to look at it is that the vaccines are less good at preventing infection and transmission than they are at preventing serious disease and death, not that they dont prevent transmission or infection at all. Lets just say that it doesnt look good when the evidence cited for the claim that the vaccines dont prevent transmission is a study as risibly awful as Subramanian and Kumar.

The rest of the paper before the VAERS dumpster diving reminds me of something I used to do with a friend of mine back when we were in junior high. It probably wont surprise readers to learn that, even at that tender age, I was a science geek (also just what was considered in the mid-1970s to be just a geek). There were times when my friend and I would wildly speculate about science that we only slightly understood, wondering if there were a link between this idea and other ideas, whether genetic engineering were possible (remember, this was the 1970s), and a whole bunch of what ifs. It was fun at the time, even though our knowledge of science was junior high science geek level, and such flights of speculative fancy no doubt increased our enthusiasm for science, to the point where both of us became doctors, me a surgeon-scientist and my friend a pathologist.

Lets just say a lot of this paper reminds me of those days, stringing ideas together without much in the way of good evidence, and saying What if? Of course, junior high science geeks ultimately grew up to study serious science, but this paper strikes me as being similar to what we did, the exception being that we were engaging in our speculative arguments innocently. This paper is not so innocent, even if it seems to have applied a gloss of scientific findings to the same sort of speculative flights of fancy. For instance, the authors try to claim that this suppression of IFN responses predisposes people to cancer:

Both IFN- and IRF9 are also apparently necessary for the cancer-preventative properties of a fully functional BRCA2 gene. In a study presented as an abstract at the First AACR International Conference on Frontiers in Basic Cancer Research, Mittal and Chaudhuri (2009) describe a set of experiments which show for the first time that BRCA2 expression leads to increased IFN- production and augments the signal transduction pathway resulting in the complexing of IRF9, STAT1 and STAT2 described previously. Two years prior, Buckley et al. (2007) had established that BRCA1 in combination with IFN- promotes type I IFNs and subsequent production of IRF7, STAT1, and STAT2. Thus, the exceedingly important cancer regulatory genes BRCA1 and BRCA2 rely on IRF7 and IRF9, respectively, to carry out their protective effects. Rasmussen et al. (2021) reviewed compelling evidence that deficiencies of either IRF7 or IRF9 lead to significantly greater risk of severe COVID-19 illness. Importantly, they also note that evidence suggests type I IFNs play a singularly important role in protective immunity against COVID-19 illness, a role that is shared by multiple cytokines in most other viral illnesses including influenza.

Being a breast cancer surgeon, I know a fair amount about BRCA2 and BRCA1, as well as their functions preventing cancer. Also note how Seneff et al. cite a 13-year-old abstract about BRCA2 and IFN- production. If I were reviewing the paper, I would have asked: Wheres the published paper? I would have noted that, given that this is a 13-year-old finding, it should have found its way into the scientific literature by now. A quick search of PubMed for anything published together by the two authors who published the abstract about BRCA2 showed me that apparently these results never made it into a full paper. Even if they had, the abstract itself simply showed that the BRCA2 tumor suppressor was needed for breast cells to make IFN-. In other words, the finding is basically irrelevant to COVID-19 vaccines or any other vaccines. If the result held up, it would really only show that the need for BRCA2 to produce IFN- in breast cells might be relevant to the cancer suppressing function of the gene. In fairness, more recent data suggest a link between BRCA2 deficiency and immune signaling, but that leaves the question: Why did Seneff et al. so selectively cite a 13-year-old abstract?

Then theres this:

A recent early-release study has found that the mRNA in the COVID-19 vaccines is present in germinal centers in secondary lymphoid tissue long after the vaccine is administered, and that it continues to synthesize spike glycoprotein up to at least sixty days post-vaccination (Rltgen et al., 2022). This suggests that immune cells taking up the mRNA in the arm muscle migrate into the lymph system to the lymph nodes, presumably in order to expose B-cells and T-cells to the toxic antigen. The persistence of the mRNA in the lymph nodes and its sustained synthesis of SARS-CoV-2 spike glycoprotein reflect the clever engineering involved in the mRNA technology, as described above.

Imagine that! The antigen sticks around in the lymph nodes to stimulate an immune response! How horrible!

This paper is rife with such odd citations about biological processes, many unrelated to vaccination or infection, all marshaled in the service of trying to convince you that mRNA-based COVID-19 vaccines cause harm. Indeed, the authors even invoke codon usage, fear mongering about coinfection with other viruses, and supposed molecular mimicry (although they dont use the term) of the spike protein because of its supposed similarity to various important human proteins. There are mentions of microRNAs (something in which I have some expertise as well) and exosomes, as well as metabolism. Rather than go through them all (or even a lot of them), Im going to quote Prof. Morris:

This very long review article presents many details about various biological pathways, most related to cancer, but their links to mRNA vaccines are almost wholly speculative. In some cases, they link to other vaccines, old mRNA technology, or COVID-19 infection, but are not directly linked to mRNA vaccines.

In fact, so much of their evidence is from papers on severe COVID-19 infections, not vaccination, much of the evidence in this article might be better suited to a paper pointing out potential downstream dangers of severe COVID-19 infections than on trying to raise alarm about mRNA vaccination.

A number of places in the article seem to make stronger statements linking mRNA vaccines to some of these processes, but they self-cite a previous review article by senior author McCullough and do not reference any primary biological research making these connections.

They suggest connections of these mechanisms to various anecdotal case reports for herpes zoster reactivation, liver damage, optic neuropathy, T cell lymphoma progression, Hepatitis C reactivation, events not yet confirmed to be related to mRNA vaccination.

The paper amounts to laying out a series of hypotheses about mechanisms of harm that may come from mRNA vaccines. Hypothesis generation is a valuable exercise, including in this context of understanding downstream biological effects of vaccination that might induce harm.

However, not all hypotheses are equally supported. Some are well-girded in direct evidence from relevant studies, while others are more speculative and extrapolate principles from other settings, e.g. SARS-CoV-2 infections or other injected vaccines, as done here.

Again, Prof. Morris is entirely too kind. I would put it a different way. This review is the scientific equivalent of a form of what the kids like to call shitposting a bunch of low-quality provocative assertions on social media designed to provoke a visceral reaction. In this case, the visceral reaction intended is disgust and fear of mRNA-based COVID-19 vaccines. Prof. Morris is, of course, quite correct when he identifies the purpose of this torrent of speculation as shifting the burden of proof, with the authors claiming that their wild speculation must be taken seriously by scientists and their proposed harms be investigated right now, rather than presenting anything resembling actual compelling evidence why their ill-formed hypotheses should be taken seriously in the context of what is already well-established about human biology and immunology:

Challenging public health institutions to disprove the assertions made by this article, rather than taking responsibility to validate them or urge other scientists to do so, is a bold move. This type of statement in which one makes a claim and presumes it should assumed true unless other scientists can disprove it, is the classic shifting the burden of truth trick. A scientist proposing a hypothesis has the burden of validating it; it is not the responsibility of the scientific community to disprove it, and the hypothesized claim certainly does not have the benefit of presumption of truth unless disproven. This is a common tactic used by many during the pandemic.

In addition, this whole review article is one big Gish gallop, in which a torrent of questionable claims is made in an attempt to overwhelm the reader with the quantity of claims, with no regard for their quality. Ive been told that its impossible to Gish gallop in a paper, because one has the time to read and address every claim, but one could easily spend 20,000 words or more to address each and every claim in this review. Thats the point. Thats why Im trying to point out how this review is similar previous efforts and to put it into context with disinformation in general

The purpose of a paper like this is to put a seemingly scientific gloss on speculative scientific bafflegab in which the various concepts are at least six degrees of separation away from any biological framework having anything to do with vaccines. Scientists with the requisite expertise recognize this handwaving as the crap that it is, but those without the requisite expertise dont. Even some doctors and scientist without the proper specialized expertise wont recognize it for what it is, disinformation.

After all the scientific shitposting (if youll excuse the term), Seneff et al. then try to make all their speculation and JAQing off sound plausible by appealing toyou guessed it!VAERS.

Lets take a look at the VAERS reports examined by Seneff et al. The easiest thing for me to do is to quote the Tweets. For example, heres Table I, which Seneff attribute to inflammation:

Indeed. There is no known mechanism by which the tiny amounts of spike protein that make it into the bloodstream after vaccination could injure the olfactory bulb and cause anosmia (loss of the sense of smell), which also happens to be a well-known symptom of COVID-19 infection itself. Theres also quite a bit of evidence that it is direct infection of the cells in the olfactory bulb with SARS-CoV-2 that is responsible for anosmia. If theres a symptom of the virus that wed expect the vaccine not to cause, it would be anosmia.

Lets just say that this passage from the review should tell you all you want to know about it. I laughed out loud when I read it:

There were nearly 100,000 cases of nausea or vomiting, which are common symptoms of vagus nerve stimulation or damage (Babic and Browning, 2014). 14,701 cases of syncope linked to COVID-19 vaccines represented 96.3% of all cases of syncope, a well-established feature of vagus nerve dysfunction (Fenton et al., 2000).

People passed out after vaccination, and that must mean the vaccine was somehow hurting the vagus nerve? Seriously, I can only laugh. Lots of people faint after blood draws or shots; its a common reaction, particularly in certain populations. Its the same sort of claim that, you might remember, antivaxxers made about the HPV vaccine because so many teenage girls faint after receiving it, except that they at least had a more plausible mechanism than that the vaccine somehow messed up the vagus nerve. Dont get me wrong. Stimulation of the vagus nerve can cause fainting. Thats why they call it a vasovagal reaction. However, in general its pain or fear that results in that stimulation.

Since Im a cancer doctor, Ill mention this one too:

The authors even admit:

Cancer is a disease generally understood to take months or, more commonly, years to progress from an initial malignant transformation in a cell to development of a clinically recognized condition. Since VAERS reports of adverse events are happening primarily within the first month or even the first few days after vaccination (Rose, 2021), it seems likely that the acceleration of cancer progression following vaccines would be a difficult signal to recognize. Furthermore, most people do not expect cancer to be an adverse event that could be caused by a vaccine, and hence they fail to enter a report when cancer develops shortly after vaccination.

They should have stopped right there, but they couldnt resist continuing:

However, as we have outlined in our paper, if the mRNA vaccinations are leading to widespread dysregulation of oncogene controls, cell cycle regulation, and apoptosis, then VAERS reports should reflect an increase in reports of cancer, relative to the other vaccines, even if the numbers are small. The experiment demonstrating impairment of DNA repair mechanisms by SARS-CoV-2 spike protein in an in vitro study provides compelling evidence that the vaccines could accelerate the rate of DNA mutations, increasing cancer risk (Jiang and Mei, 2021).

Again, Seneff et al. were right at first before they went wrong. Cancer is the culmination of a process that, in general, takes years, from the initial insult that resulted in cellular transformation to the development of a cancerous tumor detectable by symptoms, physical exam, or screening tests. As I discussed before when antivaxxers did a similar thing with another database to try to blame cancer on COVID-19 vaccines, even after radiation exposure from an atomic bomb, the increased risk of cancer from such a carcinogenic exposure is too long for this to make sense. For leukemias, its about two years before the earliest signals can be seen. (The vaccines have only been widely available for less than a year and a half). For solid cancers, the lag time is about 10 years. The increased risks from radiation from the atomic bombs dropped on Hiroshima and Nagasaki, especially those for solid cancers, were most easily detected after 30 years and remain over a persons lifetime. Basically, the authors concede (sort of) that its too early to detect an increased risk of cancer from COVID-19 vaccines but then pivot to a hand wave that says, But look at our mechanisms! Never mind that the mechanisms were highly speculative to begin with and unproven.

I could go on about the VAERS section, but Prof. Morris did a fine job with it already, and I only wanted to harp on the cancer part because Im a cancer surgeon and biologist myself. Remember, VAERS is a database to which anyone can contribute anything as a report of an adverse event after vaccination, and antivaxxers have been gaming VAERS since the 1990s. Its a problem that has only gotten so much worse since the pandemic hit. VAERS is useful as an early warning system, but only if you know how to use it, a skill that involves knowing the base rate of the adverse events reported in the population.

I started this post by pointing out how bogus scientific review articles are a long-time favorite technique of spreading antivaccine misinformation. In fact, they are a favorite tool of spreading science denial of all kinds, particularly of evolution and climate science, but I know antivaccine science denial better than I know those other forms, which is why Ill stick to a couple of examples from the past. One dates back to 2011, when a Helen Ratajczak published an article in the Journal of Immunotoxicology titled Theoretical aspects of autism: CausesA review. This review article was picked up by Sharyl Attkisson, an antivax reporter who has now become an all-around conspiracy theorist and COVID-19 denialist, to promote the claim that vaccines cause autism. As an aside, Attkissons report produced the still hilarious misspelling that those of us who have been following the antivaccine movement a long time still bring up to this day, homologous recombinaltion tiniker. She meant to write homologous recombination, the process by which DNA with a highly homologous (similar) sequence to a sequence in the genome can integrate itself in that spot, but the misspelling lives on.

Basically, Ratajczaks claim was that DNA from the fetal cells used to manufacture some vaccines could get into the brain, undergo homologous recombination with the DNA of neurons, and produce foreign proteins (fusions of self proteins plus the fetal protein) that would result in autoimmunity and cause autism. Thats it. Thats the idea, which is incredibly implausible. To do what Dr. Ratajczak claims, the minute amount of human fetal DNA in a vaccine would have to:

Thats leaving aside the issue of whether autoimmunity in the brain or chronic brain inflammation is even a cause of autism, which is by no means settled by any stretch of the imagination. In fact, quite the opposite. Its not at all clear whether the markers of inflammation sometimes reported in the brains of autistic children are a cause, a consequence, or merely an epiphenomenon of autism. In other words, Dr. Ratajczaks hypothesis is incredibly implausible on the basis of what we know about molecular biology and human biology. Its not quite homeopathy-level implausible, but nonetheless quite implausible.

Her review was useful in that it also listed another favorite hypothesis of antivaxxers from a decade ago, namely deficiencies in metal metabolism that predisposed children to autism when they were exposed to mercury (from vaccines, of course):

Defective metallothionein might be responsible for the greater amount of blood mercury found in autistic children compared to neurotypical controls (Desoto and Hitlan, 2007; Geier et al., 2010). Metallothionein plays an important role in the development and continued function of the immune response, in neuronal development, and in the detoxification of heavy metals. Many classic symptoms of autism may be explained by a metallothionein defect, including gastrointestinal (GI) tract problems, heightened sensitivity to toxic metals, and abnormal behaviors. Porphyrinuria in children with autism is considered a marker of heavy metal toxicity (Geier and Geier, 2006a; Nataf et al., 2006, 2008; Rossignal, 2007; Geier et al., 2009). Individuals with severe autism had increased mercury-intoxication-associated urinary porphyrins (Geier et al., 2009).

Again, there was (and still is) no good scientific evidence to support the plausibility of these hypotheses. I could list a whole slew of papers trying to link various metabolic processes to autism via vaccine injury but will spare you. Ill also note that the Hannah Poling case was a huge driver of papers claiming to link mitochondrial disorders to autism via vaccine injury. The idea was that mitochondrial disorders make a child susceptible to neurologic damage due to fevers due to vaccines. But you know what causes fevers more effectively? Actual infections! Thats why it is highly recommended that children with mitochondrial diseases receive the full slate of childhood vaccines. And dont even get me started on another highly speculative mechanism how vaccines could supposedly cause autism known as microcompetition.

One thing that distinguishes Ratajczaks review from that of Seneff et al. is that Ratajczak discussed a number of non-crank hypotheses with actual science behind them (e.g., the association of certain gene mutations, increased paternal age, and more) along with her vaccine-autism causation pseudoscience, the better to disguise the antivaccine pseudoscience. Seneff et al. could have learned from that, but apparently they didnt. The idea was the same, though, to get a review article into the scientific literature to provide scientific-sounding highly speculative talking points that antivaxxers could use to blame autism on vaccines, exactly the same thing that Seneff et al. accomplished.

Finally, Seneff et al. was published in Food and Chemical Toxicology, a journal by a large scientific publishing house, Elsevier. I note that its the same journal that published Gilles-Eric Sralinis awful GMO study that was ultimately retracted. More importantly, it is a journal that had no business publishing a review article like this, given that its not a journal dedicated to vaccines, infectious disease, epidemiology, or other relevant specialties. It is a toxicology journal, but its a stretch for it to cover alleged adverse reactions from COVID-19 vaccines and a whole lot of Gish galloping about potential biological mechanisms for those complications. One has to wonder why Jose Luis Domingo, who is listed as the editor who handled this review, let it pass and why the peer reviewers didnt reject it.

I think I know why. The most charitable explanation is likely twofold. First, COVID-19 articles, particularly ones claiming adverse reactions from vaccines, bring clicks, and editors want to publish them. More importantly, though, an explanation that doesnt require any sort of conflict of interest or nefarious motivation on the part of the journal editor is that neither journal editors nor peer reviewers recognize misinformation and disinformation. They therefore reviewed Seneff et al. as though it were a serious attempt at a scientific review, not recognizing the Gish galloping. Even giving them that benefit of the doubt, though, I have a hard time not faulting them for failing to recognize the highly speculative nature of the claims, the obvious misuse of VAERS, and the even more highly selective citation (and self-citation) of papers that dont really support the hypotheses proposed, at least not without a lot of contortions of logic and biology. These were not subtle flaws.

As professions, we scientists and physicians could in the past be blissfully oblivious to misinformation and disinformation. No longer. If we dont get our acts together to recognize them, the result will be many more reviews like this weaponized to attack public health. Actually, its already too late, but maybe the deluge can be at least reversed and the cranks forced to publish this nonsense where they used to: In bottom-feeding journals and on their own websites, rather than in Elsevier journals.

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Scientific review articles as antivaccine disinformation - Science Based Medicine

Job Description

Are you a biomedical researcher motivated to pursue an outstanding career in cancer research with a focus on organoid research?

Cancer will affect more than 1 in 3 Singaporeans. At the Cancer Science Institute (CSI), our mission is to be at the global forefront of research to overcome this scourge. Our innovative international faculty, cutting-edge facilities, supportive working environment and competitive package together enable each of our staff to realize their maximum potential.

We now seek a Research Assistant/ Associate to join the team of Prof. Ashok Venkitaraman. This is an exciting opportunity to work closely with a world-leading cancer researcher to undertake pioneering research on the role of genome instability in human carcinogenesis (eg., see Venkitaraman Science (2014) PMID:24675954 and Venkitaraman DNA Repair (2019) PMID:31337537).

The role will provide expertise in the establishment, genetic manipulation and maintenance of human and murine organoid cultures as well as design/ perform and analyse work within the project parameters.

Duties And Responsibilities

Research:

Lab Management:

Qualifications

Knowledge of:

Ability to:

Covid-19 Message

At NUS, the health and safety of our staff and students are one of our utmost priorities, and COVID-vaccination supports our commitment to ensure the safety of our community and to make NUS as safe and welcoming as possible. Many of our roles require a significant amount of physical interactions with students/staff/public members. Even for job roles that may be performed remotely, there will be instances where on-campus presenceis required.

In accordance with Singapore's legal requirements, unvaccinated workers will not be able to work on the NUS premises with effect from 15 January 2022. As such, job applicants will need to be fully COVID-19 vaccinated to secure successful employment with NUS.

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Research Assistant, Cancer Science Institute job with NATIONAL UNIVERSITY OF SINGAPORE | 290831 - Times Higher Education

New Delhi: For centuries, humans have searched for ways to protect each other against deadly diseases. Immunisation has a long history, from experiments and taking chances to a global vaccine roll-out in the midst of an unprecedented pandemic.

Vaccines provide everyone a chance at a fulfilling life, and have helped keep people healthy for more than two centuries, be it the very first vaccine developed to protect against smallpox to the latest vaccine used to prevent severe cases of Covid-19.

The world has witnessed the unparalleled impact of vaccines on health and well-being, ever since the first vaccine was developed for smallpox in 1796. For centuries, people worldwide have been vaccinated. This led to the eradication of smallpox and driving down of wild polio cases to an all-time low.

Every year, World Immunization Week is celebrated worldwide in the last week to April, to highlight the importance of vaccines and how immunisation helps protect people from vaccine-preventable diseases.

Immunisation is one of modern medicine's greatest success stories, and prevents deaths every year in all age groups from diseases like diphtheria, tetanus, pertussis (whooping cough), influenza, and measles. The Centers for Disease Control and Prevention (CDC) engages globally to support the development and implementation of vaccination strategies and programmes that can prevent more than 25 vaccine-preventable diseases.

Immunisation currently prevents four to five million deaths every year, according to the World Health Organization (WHO).

From smallpox to Covid-19, here is a story of how vaccines have saved lives for centuries.

The basis for vaccination began in the year 1796. English doctor Edward Jenner noticed that milkmaids who contracted cowpox were protected from smallpox, and also knew about variolation, which was one of the first methods for controlling smallpox. Named after variola virus, the causative organism of smallpox, variolation was a process during which people who had never contracted smallpox were exposed to material from smallpox sores called pustules by scratching the materia into their arm or inhaling it through the nose. Fewer people died as a result of variolation, compared to the number of deaths that would have occurred if smallpox was acquired naturally.

Jenner guessed that exposure to cowpox could be used to provide protection against smallpox. He tested his theory on James Phipps, the nine-year-old son of his gardener.

Jenner inoculated material from the cowpox sore on the hand of milkmaid Sarah Nelmes into the arm of Phipps, and exposed him several times to the variola virus. Surprisingly, Phipps never developed smallpox.

After conducting more experiments, Jenner published his treatise "On the Origin of the Vaccine Inoculation", in 1801, in which he summarised his discoveries and expressed hope that the "annihilation of the smallpox, the most dreadful scourge of the human species, must be the final result of this practice."

Vaccine was gradually accepted, and replaced the practice of variolation. In the 1800s, the virus used to make smallpox vaccines changed from cowpox to vaccinia virus.

The Kingdom of Bavaria was one of the first countries to introduce compulsory vaccination according to Jenner's method. On August 26, 1807, the Royal Bavarian Government Gazette published a decree "concerning smallpox vaccination to be introduced by law in all provinces."

In the Kingdom of Bavaria, vaccination certificates were issued after successful vaccination against smallpox. These certificates were usually simple slips of paper. The only exception was a certificate issued in Graz, Styria, in 1855, which depicts Jenner, milkmaids, children, and a cow.

ALSO READ | World Immunization Week 2022: Google Shares One Of The Earliest Vaccination Certificates Ever. Know The Disease It Was For And All About It

The vaccination set for smallpox was made in Tuttlingen, Germany, and was manufactured between 1920 and 1930. It consisted of a knife, which was sterilised before being dipped into the vaccine. Then, the vaccine was inoculated into the upper arm of a person with two small cuts.

A few days after the vaccination, a small pustule was formed on the upper arm, which scarred characteristically, indicating that the vaccination was successful.

Due to the success of vaccination, smallpox was eradicated, and no cases of naturally occurring smallpox have occurred since 1977.

On May 8, 1980, the 33rd World Health Assembly, the decision-making body of the World Health Organization, declared the world free of smallpox. This was almost two centuries after Jenner hoped that vaccination could annihilate smallpox.

For his contribution to Immunisation, Jenner is also known as the "father of immunology".

Imvanex is the vaccine currently approved for vaccination against smallpox, and is developed by Bavarian Nordic based on the Modified Vaccinia Ankara virus strain. The vaccine can be injected subcutaneously and is approved for inoculation in people with immune deficiencies. Despite the fact that smallpox is considered eradicated, samples of the virus are still stored in research laboratories in the United States and Russia.

European typhus fever, also called "spotted fever" and "ship fever", is different from typhoid fever. For generations, the disease was the scourge of armies, and still flourishes in Poland, Russia, and the Balkans. Spotted fever is caused by a bacterium called Rickettsia prowazeki, which dwells in the intestines of filthy little insects. The virus is transmitted by lice and fleas.

The infection does not occur when a louse bites; rather, the bacteria are found in lice faeces, which enter the host's body through the bite wound.

Professor Rudolf Weigl of the University of Lemberg, Poland created a vaccine for spotted fever. The vaccine did not provide full immunity against the disease, but substantially reduced the symptoms.

The vaccine provided protection against severe forms of the disease for at least one year. Weigl obtained his vaccine from infected lice intestines.

According to Google Arts and Culture, Weigl managed to save the lives of thousands of people, including Polish University professors and Jewish citizens, by classifying their dangerous work as "louse-feeders" as "important to the war effort". Louse-feeders were human sources of blood for lice infected with spotted fever, which were then used to research possible vaccines against the disease. This was a job in interwar and Nazi-occupied Poland, at the Lviv Institute for Study of Typhus and Virology, and the associated Institute in Krakow, Poland. Weigl and his wife were some of the earliest lice-feeders.

Typhoral was a solid vaccine used for oral inoculation against typhoid fever in the 1940s.

Typhoral contained killed typhoid bacteria Salmonella typhi and paratyphoid bacteria Salmonella enterica, in order to stimulate the immune system to produce antibodies.

The vaccine provided protection for about six to 12 months.

Currently, a live vaccine containing non-disease-causing Salmonella typhi bacteria is used for oral typhoid vaccination.

People were vaccinated against Polio for the first time in West Germany, in the year 1956. A vaccine developed by US physician and immunologist Jonas Salk was used.

The vaccine, called Virelon, contained killed poliovirus. However, only a few people agreed to get themselves vaccinated against Polio. Salk became a national hero when he alleviated the fear of polio with his vaccine, approved in 1955. However, Salk's vaccine was not the last polio vaccine. Albert Sabin, a Polish-American researcher, introduced an oral vaccine in the United States in the 1960s which replaced that of Salk.

Sabin's live vaccine was available on sugar cubes. Its motto was "oral vaccination is sweet!".

Between 1963 and 1999, Sabin's vaccine largely replaced Salk's vaccine everywhere in the world, according to the Smithsonian National Museum of American History. However, the live virus in the vaccine occasionally became strong enough to cause the actual disease, because of which Salk's killed-type vaccine replaced the live-type vaccine in the US.

Tetanus, caused by Clostridium tetani, is usually fatal. However, it is the toxins produced by the bacteria, rather than the bacteria themselves, which primarily cause symptoms, according to an article published by Smithsonian institution. The same is true for diphtheria and pertussis. Currently, tetanus, diphtheria, and pertussis can be addressed by a single, combined vaccine.

A vaccine to prevent tetanus, called tetanus toxoid, was introduced in 1924. Tetanus toxoid is an inactivated form of the toxin, which teaches the body to recognise and produce antibodies against the toxin, but is not able to damage the body itself. The vaccine was not frequently used until World War II, during which it became one of the routine vaccinations given to all American soldiers.

The pure toxin is converted into a non-toxic form called toxoid by treatment with formaldehyde. The toxoid is adsorbed to a mineral carrier such as aluminium hydroxide, and serves as a vaccine.

Due to routine vaccination in the United States, death from tetanus has become rare. However, it is important to repeat a vaccination booster every ten years to keep that

immunity. People who do not contract tetanus can be treated with a modern form of antitoxin, called tetanus immune globulin.

Each winter season, the World Health Organization selects different virus strains which are likely to be responsible for influenza illnesses in a particular hemisphere during the respective flu season.

The Influsplit Tetra vaccine is indicated for the prevention of the genuine viral flu or influenza in adults and children aged six months and above, caused by the two influenza A virus subtypes and the two influenza B lineages. These strains are contained in the vaccine.

A single prick can protect one against mumps, measles, and rubella, when they are inoculated with a combination vaccine.

The MMR (mumps, measles, rubella) vaccine "Priorix" is a combination vaccination.

Combination vaccines were first used in the 1970s. The protective effect is not compromised, and fewer additives make them better tolerated. Also, only one appointment with the doctor is necessary.

Other combination vaccines include those for tetanus, diphtheria, pertussis, and polio, or Hepatitis A and B.

German Nobel laureate Harald zur Hausen had proved that infection with human papillomaviruses (HPV) or wart viruses plays a decisive role in the development of cervical cancer or cervical carcinoma. The discovery was important because it led to the development of HPV vaccines.

Available since 2006, HPV vaccines specifically protect against certain sexually transmitted human papillomaviruses.

Gardasil 9 is a new nine-drug vaccine which provides protection against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. The United States Food and Drug Administration (FDA) approved Gardasil 9 in 2014.

Gardasil 9 is produced through genetic engineering and contains only non-infectious viral envelopes.

Ervebo vaccine is an Ebola vaccine that prevents Ebola caused by the Zaire ebolavirus. It is manufactured by Merck. Ebola is one of the deadliest viruses in the world.

The genetic material for a vaccine antigen is inserted into a carrier virus, which is then injected into the Ervebo vaccine. The protein of the virus' genetic material is incorporated into the surface of the vector, which is then introduced into the body of the human.

The proteins trigger the production of antibodies in the vaccinated person. Ervebo is the first new vector technology-based vaccine to be approved.

Pfizer-BioNTech is an mRNA-based vaccine developed in the year 2020 by German pharmaceutical company BioNTech in collaboration with US pharmaceutical company Pfizer against SARS-CoV-2, or the novel coronavirus.

Since naked mRNA is physically and thermally unstable, it cannot reach the site of action without being degraded. In order to avoid this and to make sure that the vaccine is effective, the mRNA is packaged inside lipid nanoparticles called lipid beads. When these are injected into the body of a person, the cells take up the lipid beads, and produce the S protein, or the spike protein on the genetic material.

The immune system recognised the spike protein as foreign, stimulating the production of protective antibodies.

ALSO READ | World Immunization Week 2022: Know The Week's Significance & What The Theme 'Long Life For All' Means

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World Immunization Week 2022 | From Smallpox To Covid-19: How Vaccines Saved Lives For Centuries - ABP Live

(Photo : Skye Yayoi Drynan)

While investors who make strategic investments in undervalued companies can transform said business as well as their own portfolio, investors who make strategic investments in companies with an ethical purpose can change the world. The investors that history remembers kindly are not the ones with the highest yields; history looks fondly on the investors who use their economic power to help bring positive to individuals and society at large. Investors who are looking to make a difference have a wide array of industries and companies on a moral mission to choose from.

Biotechnology is a thriving industrywith a plethora of innovative companies using cutting-edge technology to solve the most complex and important health issues of our time. Of course, as the COVID-19Pandemic spread throughout the world over the last few years, investments and innovations in biotechnology are more important now than ever.

Skye Drynanis an investor, entrepreneur, inventor, and thought leader pioneering multiple market-disrupting projects in the biotechnology space, helping people live happier and healthier lives. Drynan has a long history in both investment and biotechnology, always betting on herself. Whether it's excelling on the boys' soccer team as a teenager, becoming the first person in the history of Putnam Investments to transition from their operations division to their investment division, or asking to become the Global Head of Health Care at Credit Suisse at just 27 years old, Drynan knows she can overcome any challenge and reach any goal she sets her mind to.

As a female who has risen to the top of multiple male-dominated industries, Drynan understands what it is like to be underestimated and put in a box. In addition to breaking into multiple 'boys clubs,' Drynan is constantly misunderstood by her peers due to her knowledge about and success in a wide variety of fields. As an inventor with 7 original issued bra patents plus an issued seamless shopping patent called UWIN (U Want It Now), a fashion enthusiast and entrepreneur, and a successful biotech investor who can speak technically about the industry, the depth and width of Drynan's knowledge is unparalleled. Drynan likes to joke that she is just as "comfortable on the red carpet as she is in the boardroom and as a keynote speaker." In addition to the hard work necessary to rise to the top of any field as a technical investor and entrepreneur, Drynan has unfortunately experienced personal and familial health issues over the course of her life. These personal experiences inform Drynan's interest in and excitement about biotechnology.

After graduating from Wellesley and becoming the first person in the history of Putnam Investments to transition from a call center to their investment division, Drynan continued to overachieve and outperform her peers. In her first year in the investment division, Drynan took another risk, speaking truth to power about an investment decision when other employees in her cohort stayed silent about Eurotunnel and Canary Wharf's untenable debt structures. Ultimately being proved right -- helping the company minimize its risks and maximize its returns -- Drynan finished at the top of her class.

Eventually, Drynan would take her newly honed investment skills in order to serve and honor her love for biotechnology; Drynan went to work for Margaret Smith just at the beginning of the genomic boom. After getting special permission to take a genetic engineering course at Harvard and spending two nights a week at MIT labs, Drynan quickly built her technical understanding of the science powering the most important biotechnology innovations. This allowed Drynan to work for a small sell side boutique company in New Jersey building her book of business with some of the largest players in the industry. Her short report on Schering-Plough paved the way for Drynan to join Credit Suisse Asset Management.

Drynan had to prove herself once again, working hard to prove to the CEO that she deserves the job as the Global Head of Healthcare. Drynan bet on herself and took a risk yet again by asking the CEO of Credit Suisse Asset Management to become the Global Head of Health Care. Impressing him with her presentation, her confidence in herself, and her desire to make successful biotechnology investments in companies that were poised to make a positive difference in the world, Drynan secured the job. Stating that he probably would not have given her the job unless she asked, Drynan's willingness to bet on herself bore fruits once again.

This gave Drynan even more experience and legitimacy to take a position at Capital Group, working with some of the most innovative and life-saving biotechnology companies in the world over the last 12 years. During this time, Drynan made partner, became widely recognized as a thought leader in the industry, and has worked with companies to drive the science forward in genetic engineering, cellular therapies, cancer cures, viral treatments, and vaccines.

Recently, Drynan finally made the jump to be her own boss, investing in biotechnology ventures as well as starting her own fashion and tech enterprise. Using her 7 original issued bra patents (+2 patents pending) and 1 issued tech patent (+1 patent pending) , Drynan is now the CEO of House of Skye, a high-tech, high-function, high-fashion brand. Drynan's unique ability to combine the best of fashion and technology has sparked the interests of Carrie Underwood, Lady Gaga, Paris Hilton, Gwen Stefani, Kevin Jonas, Kelly Mi Li and more - all of whom have been seen in House of Skye.

As a thought leader and market-moving investor in biotechnology, we are excited to see how Skye Drynan continues to improve the world with her strategic biotechnology investments as well as her new entrepreneurial projects.

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Nanotechnology is a vast field which includes a range oftechnologies at the nano scale, being applied to pharmaceuticals,biotechnology, genomics, neuroscience, robotics and informationtechnologies and more. In India it holds importance particularly inthe nanobiotech & nanomedicine segments. The commencement ofnanobiotechnology in India has unfurled a series of questions andchallenges in terms of intellectual property protection. Therefore,it is of immense importance to explore whether the Indian PatentSystem presents suitable atmosphere for appropriate patentprotection in India.

Like any new technology, nanobiotechnology also createsopportunities as well as challenges in adapting the patent regimeto its particular context. This article strives to highlightproblems and challenges faces by Nanobiotechnology invention owingto their multi-disciplinary character, crosssectoral applications,broad claims, as well as difficulties in fulfilling thepatentability criteria of novelty, non-obviousness, and industrialapplication.

Challenges for Nanobiotechnology Invention under Indian PatentsAct 1970

Nanotechnology is a novel and revolutionary branch oftechnology, where reduction in size has demonstrated magnificentresults. Intersection with the field of biotechnology has givenrise to nanobiotechnology. Involvement of living forms and thepotential to meet human necessities have raised issues that areunique to nanobiotechnology. It has emerged as an interdisciplinaryfield of research and development that integrates engineering,physical sciences, and biology through the development of verysmall physical and biological devices using biomimetically inspirednanofabrication techniques1 .

Following challenges are faced under Indian Patent regime inPatenting of Nanobiotechnology Inventions:

According to section 3(d) of the Act, if there is vagueness inthe "particle size", it attracts the possibility of beingincluded in non-patentable subject matter. In case ofnanobiotechnology, the newness of technology is significantlyderived from the reduction in size. The primary ambiguity is lackof a universal definition of nanobiotechnology. The word"nano" encompasses inventions of 100nm in size orsmaller. Pharma industry is likely to be the most beneficiarysegment from nano biotechnology aided research. Nano particleefficacy or accuracy of methods using nano particles for drugdelivery is significantly ruled by particle size which may vary asdifferent drugs are effective with different particle size. Forthis reason, fixing a size limit of 100 nm may rule out thepatenting of such particles under the "nano"regime.5 There is lack of a standard for determinationof the efficacy and quantification of enhancement of efficacy inthe Indian patent regime.

Under this regime, nanotech invention would remain nonpatentableunless the particle size differed in its properties have showedenhanced efficacy. Patentability of drugs would revolve around thereduction in particle size to certify better efficacy, suchcontraventions with provision 3(d) is likely to occur. For example,Abbott Pvt. Ltd. sold an HIV drug Kaletra under brand name"Alluvia". To overcome the storage problems of the drug,Abbott claimed a heat-stable form of the same drug. Apre-opposition was filed by the organization, 'Initiative forMedicines, Access and Knowledge,' under section(d) of thePatents Act 1970.6

Utility requirement is crucial for nanobiotechnologybasedinventions. Nano biotechnology falls under the class of"unpredictable" arts like biotechnology. There is thepossibility of huge variation in the laboratory results andauthentic results when technology such as nanobiotechnology is putto use. In the laboratory stage, it is not possible to determinethe possible impact of external factors on products born out of atechnology. Inoperability of such products may render themnon-patentable as they would fail to comply with the utilityrequirements.7

In addition, the problem-solving approach applied in both Europeand India would render them as not being inventions (thus renderingthe problem insolvable). The case of EMI Group North America Inc vCypress Semiconductor Corp8 provides a better insightinto the requirement. The applicant claimed a patent for aninvention that lacked utility.

The Nanobiotechnology patent can be sought over the process ofpreparing the nanoparticles; the process of transfer of nanoparticles into the patient's body; the medical devices usedetc.9 Here significant question is the distinctclassification of methods as medicinal, surgical, curative,prophylactic, diagnostic and therapeutic and the subject matterthat each of them cover. It is argued that exempting medicalmethods from the purview of patentability is on the one hand, infavour of public policy, whereas allowing patents in this fieldwould draw unwarranted ethical, moral and practical problems andmay also fail to fulfil the industrial applicability criteria.

The problem in the present perspective is whether methods usingnanoparticles constitute diagnostic, surgical or therapeuticmethods. Amendments to the Indian Patents Act 1970, sec 3(i) can beimported from the European jurisdiction which has proposedsignificant amendments to their provisions similar to the IndianPatents law, regarding medical methods. Many of the technologiesbeing currently developed blur the line between non-patentablemethods for treatment and diagnostics practiced on the human bodyon one side and patentable products (substances or compositions)and apparatus used in such activities on the other. Some of theseimportant developments in diagnostics and treatment operate totallyin vitro, others entirely in vivo, some have a combination ofphases in vitro and in vivo, posing patentability questionsconcerning the patentability exception for Methods for treatmentand diagnostic (Hosseini et al., 2011; Daneshyar et al.,2006)10.

Followings are some examples of Nanobiotechology inventionsemployed as drug delivery system in medical methods for treatmentand diagnostic purposes:

Nanoparticles due to their small size have proved to be moreefficient, target specific, water soluble and stable tools in drugdelivery compared with the conventional routes of drugadministration. For decades pharmaceutical sciences have been usingnanoparticles to reduce toxicity and side effects of drugs. Thistechnology raises issues which are in disagreement withintellectual property rights protection and non-commercial laws(such as the environmental laws). In the absence of consonantpatent law provisions, nanotechnology is facing challenges withrespect to the criteria of novelty, inventive step, being capableof industrial application and eligibility of subject matter undersection 3 of the Indian Patents Act 1970.

Nanobiotechnology inventions have generated technologicalrevolution and emerged as a key technology for economic developmentin the twentyfirst century. The use of eco marks on nanobiotechnology products are proposed to ensure environmental safetyand consonance. This would further assist in dealing with thechallenges discussed in the nanobiotechnology products Since patentlaw is technology-specific, providing guidelines to examiners forassessment of patent applications is a good practice and should beencouraged as it would aid in the issuing of better qualitynanobiotechnology patents.

1 Daneshyar SA, Kohli K and Khar RK (2006) Biotechnologyand intellectual property. Sci. Res. Essay. 1, 020-025

2 http://www.indjst.org/March%2012-%20web/38%20paper-6.pdf

3 http://www.law.ed.ac.uk/ahrc/script-ed/vol6-2/sharma.asp.

4 http://www.indjst.org/March%2012-%20web/38%20paper-6.pdf

5 Hosseini et al., 2011; Daneshyar et al.,2006

6 http://www.law.ed.ac.uk/ahrc/script-ed/vol6-2/sharma.asp

7 http://www.law.ed.ac.uk/ahrc/script-ed/vol6-2/sharma.asp

8 "Intellectual Property Rights of Nanobiotechnologyin Trade Related Aspects of Intellectual Property Rights Agreement(TRIPS)" Vol. 6, 5664, 2012, Journal ofBionanoscience

9 http://www.law.ed.ac.uk/ahrc/script-ed/vol6-2/sharma.asp

10 Hosseini SJ, Esmaeeli S and Ansari B (2011) Challengesin commercialization of nano and biotechnologies in agriculturalsector of Iran. Afr. J. Biotechnol. 10, 6516-6521.; Daneshyar SA,Kohli K and Khar RK (2006) Biotechnology and intellectual property.Sci. Res. Essay. 1, 020-025.

The content of this article is intended to provide a generalguide to the subject matter. Specialist advice should be soughtabout your specific circumstances.

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Patenting Of Nanobiotechnology Inventions: Exploring The Challenges Under The Indian Patent Law - Intellectual Property - India - Mondaq

NEW YORK, April 25, 2022 /PRNewswire/ --The global Heating, Ventilation, and Air Conditioning (HVAC) system marketsize is expected to reach USD 219.49 Billion in 2030 and register a revenue CAGR of 5.5% over the forecast period, according to latest report by Reports and Data. Rapid integration of sensors and other similar components into industrial equipment plays a critical role in driving HVAC system marketrevenue growth. A sensor is a type of component when integrated into a device responds to any changes in physical environment and sends output signals. Specific input could be light, heat, motion, moisture, and any other environmental phenomena. The output generated is a signal that is transmitted electronically over a network for reading or further processing.Advanced HVAC system designs incorporate a wide variety of sensors. These sensors aid in measuring and controlling temperature, humidity, air quality, and building pressure. Moreover, it aids designers in identifying critical areas where further improvements can be done. A pressure sensor, for instance, is a critical component used within the HVAC system. It monitors pressure levels within specific zones and measures pressure drop across filters and other components thereby alerting system when maintenance and filter replacement is required.

Rising demand for HVAC systems from food production industry is a key factor driving market revenue growth. Cooling and heating systems play a major role in several industries. However, in food production and storage this is even more important. Food products in storage spaces might get affected by volume of space, quality of air, humidity, and number of workers present in the location. Therefore, it needs to be preserved. Moreover, a properly designed and installed air conditioning unit is essential for food factories. It aids in controlling airborne particulates and odors. In addition, it also minimizes risk of any contamination by keeping food products fresh all time.

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Flooring Market, By Type (Non-resilient, Resilient, Soft Covering), By Application (Healthcare Buildings, Education Buildings, Commercial, Residential Buildings, Sports Complexes), By Material (Wooden, Vinyl and Rubber, Tiles), and By Region Forecast to 2030

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HVAC System Market Size To Reach USD 219.49 Billion In 2030 | Rapid Adoption Of Energy-Efficient Air Conditioners In Consumer Products Is A Major...