scientific misconduct
The aim of this randomized, triple-blind, placebo-controlled clinical trial was to analyze the effect of using Bach’s emergency compound, Five-Flower essence, on the stress level of mothers with premature newborns.
The study was conducted with 117 postpartum women. They were divided into intervention (with five-flower) and control groups. Their children were admitted to a Maternity Hospital in São Paulo, Brazil, from June 2019 to May 2021. The use of the Five-Flower essence was proposed during hospitalization (4 drops every 15 min four times a day) and at home (16 drops a day at pre-determined times) in the ten days after the first intervention. The pre-and post-intervention parameters were evaluated using the Instrument Parental Stress Scale: Neonatal Intensive Care Unit and cortisol analysis. Student’s T, Mann-Whitney, Chi-square, Fisher’s exact tests, and Generalized Estimating Equation models were used to analyze the data. The 5 % significance level was considered in statistical tests.
The groups were homogeneous regarding sociodemographic, obstetric, and neonatal characteristics (p > 0.05). Mean stress scores were calculated for the control (3.75) and intervention (3.82) groups before intervention and a range was observed for the control (2.75-3.44) and intervention (2.55-3.54) groups after the intervention; the difference between groups was statistically significant (p < 0.05). Mean cortisol levels were calculated for the control (3.53) and intervention (3.45) groups before intervention and a range was observed for the control (3.38-2.75) and intervention (2.32-2.86) groups after intervention, showing distinct declines in the groups but without statistical difference (p > 0.05).
The authors concluded that the use of the Five-Flower essence as a non-pharmacological therapy is effective in reducing the stress and cortisol levels in mothers of premature newborns admitted to neonatal and semi-intensive care units.
This is odd!
The remedy does not contain relevant doese of pharmacologically active molecules (other than alcohol). This means that, in this study, the authors tested one placebo against another one. Why then is there a differnce in the outcome?
I read the paper carefully in an attempt to find out. Here is what might have happened (the article does not disclose all the relevant details, so I can only guess):
- The placebo which the authors fail to describe was a water solution or a solution that tasted different than the verum.
- The authors do, however, state this: “Regarding blinding, the manufacturer of the flower essences previously identified the bottles as A and B, one of which was the intervention and the other the placebo.”
- It is possible that the patients were de-blinded, meaning one or two knew how the Bach remedy should taste and communicated this to the several other patients.
- In this case, the expectation of patients affected the results accordingly. In other words, the results are due to a placebo effect.
In any case, the conclusion (even if the ‘Five-Flower essence’ did work exactly as described) is far too optimistic. Before anyone might accept the results, we need an INDEPENDENT replication of this dubious study.
Anxiety disorders are among the most prevalent psychiatric conditions, often impairing daily functioning, social interactions, and overall quality of life. Conventional pharmacotherapy can be associated with side effects, prompting interest in alternative treatments such as homeopathy. This randomized controlled trial evaluated the efficacy of individualized homeopathic remedies in reducing anxiety symptoms compared to placebo.
Eighty participants diagnosed with generalized anxiety disorder (GAD) according to DSM-5 criteria were randomized into Homeopathy Group (HG, n=40) and Placebo Group (PG, n=40). Interventions lasted 8 weeks. Outcomes were measured using Hamilton Anxiety Rating Scale (HAM-A), Generalized Anxiety Disorder 7-item (GAD-7) scale, and patient-reported quality of life (QoL) scores.
Post-intervention, the HG showed significant reductions in HAM-A scores (mean reduction: 12.5 ± 3.1 vs. 6.2 ± 2.7, p<0.001) and GAD-7 scores (HG: 10 ± 3 vs. PG: 4 ± 2, p<0.01).
The authors concluded that these findings suggest individualized homeopathic treatment may effectively reduce anxiety symptoms and improve QoL, offering a complementary approach for managing mild-to-moderate anxiety disorders.
This paper lacks almost everything that is required to assess its alleged findings. In fact, I don’t remember ever seeing a clinical trial reported in such an insufficient way. It has a single author, Dr. Rajeshwar Pratap Singh Assistant Professor, Department of Environmental Sciences, Jawaharlal Nehru University, New Delhi, which is mmost unusual for a study of this nature that requires plenty of cooperation from others.
The article was published in volume 1 of issue 1 of the “European Journal of Complementary and Alternative Medicine” which claims to be “an internationally recognized, peer-reviewed journal dedicated to advancing the understanding, research, and practice of complementary and alternative medicine (CAM). The journal provides a platform for clinicians, researchers, educators, and practitioners to share innovative approaches, evidence-based studies, and critical analyses in the field of CAM.”
The European Journal of Complementary and Alternative Medicine is about as scientifically rigorous as the author of the above article is cagey about essential details of his study. One thing, however, seems quite clear to me: nobody can advance CAM by publishing papers that have all the hallmarks of being fraudulent!
Fatigue is one of the most common symptoms in patients with Multiple Sclerosis (MS). It can cause severe psychological problems and reduce their Quality of Life (QOL). Cupping therapy is known as a method of alternative medicine that can be used to treat or reduce patient symptoms. Thus, this randomized clinical trial was conducted to determine the effect of dry cupping therapy on the fatigue and QOL of women with MS.
It 60 patients (30 patients in each group) with MS referred to the Medical Center of Special Diseases in southeast Iran. Patients in the intervention group received eight sessions of dry cupping therapy (plus standard care) twice a week over 4 weeks, while the control group received just standard care. Data were collected before and after the intervention by using the demographic information questionnaire, the Fatigue Severity Scale, and the Multiple Sclerosis Quality of Life questionnaire. Data were analyzed using SPSS 18. The significance level was 0.05.
Thirty patients entered the study; none of them were excluded from the study, and 30 patients were finally analyzed. Before the intervention, there was no statistically significant difference between the two groups in terms of fatigue (intervention group: 47.67) 7.83); control group: 47.63) 8.76)) and QOL (intervention group: 48.85) 9.55); control group: 49.64) 9.90) (t = 0.018, p = 0.98 and t = 0.31, p = 0.75, respectively)). After performing cupping therapy in the intervention group, a significant decrease and increase were observed in the mean (SD) score of fatigue (intervention group: 34.48) 6.16); control group: 46.85 (8.95)) and QOL (intervention group: 60.14) 7.46); control group: 51.96) 9.45)), respectively (p < 0.001).
The authors concluded that cupping therapy significantly reduced the patients’ fatigue and increased their QOL. This method is recommended for reducing fatigue and improving QOL in patients with MS.
Oh dear, where to begin?
One is spoilt for choice when criticising this study, e.g.:
- A controlled trial is meant to compare the outcomes BETWEEN groups and not to calculated within-groups changes.
- The results of a single study should never be the basis for far-reaching recommendations.
- The study followed the infamous ‘A + B versus B’ design. This does not control for placebo effects and thus does not permit conclusions about a therapy per se. (For those new to the subject, I have previously dealt with this study design as nauseam. Please do a simple search of previous explanations)
In view of this, I think I ought to re-phrase the conclusions as follows:
Like most treatments, cupping therapy is associated with significant placebo effects which can significantly reduce the patients’ fatigue and increased their QOL. Studies that fail to control for placebo effects cannot tell us about the sepcific effects of medical interventions and therefore are prone to mislead the public.
In November 2020, Frass et al published the study that prompted much confusion and concern. Its conclusions were as follows:
QoL improved significantly in the homeopathy group compared with placebo. In addition, survival was significantly longer in the homeopathy group versus placebo and control. A higher QoL might have contributed to the prolonged survival. The study suggests that homeopathy positively influences not only QoL but also survival. Further studies including other tumor entities are warranted.
On 7 October 2020, I was probably the first to voice concerns about this most suspicious piece of research in a blog post that raised no less than 13 questions about this trial:
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- What is the purpose of group 3? The authors call it a control group and state it allows assessing the real homeopathic effect on the homeopathic cohort as the real effect will be the natural historical effect minus the placebo effect and the homeopathic effect. Does that make sense?
- Was the study under-powered? From my reading of the text, the answer seems to be yes.
- What is the full list of conventional treatments the patients received, and did they differ between the 3 groups?
- If I understand it correctly, the study patients did not receive immuno-oncological therapy. Does that fact not render the study unethical?
- What homeopathic potencies were prescribed in group 1? The paper says: The constituents of the different homeopathic remedies were mainly of plant, mineral, or animal origin. This is unlikely, as most homeopathic remedies contain nothing.
- The authors seem to have used individualised homeopathy according to Hahnemann’s instructions. Did Hahnemann not strictly forbid combining his approach with other types of treatment?
- How well respected is THE ONCLOLOGIST, the journal that published the paper?
- Was the article peer-reviewed? If so, by whom?
- Was the placebo indistinguishable from the verum?
- Was the success of patient-blinding checked?
- Have similar findings regarding survival been reported previously? The authors call this finding ‘unexpected’; I find it more than that; it is baffling.
- Should we accept such surprising findings, or would it be more prudent to wait until independent replications are available?
- The first author of this trial is Prof Frass who has featured on this blog several times before (see for instance here, here, here, here and here). Frass has published several studies of homeopathy and invariably manages to produce positive results. Am I the only one to find this odd?
Subsequently many more in-depth critiques have been published by colleagues on this blog and elsewhere, e.g.: A thorough analysis of Prof M. Frass’ recent homeopathy trial casts serious doubts on its reliability. This was followed by several complaints to The Oncologist, the journal that had published the article. Frass countered with a statement:
This is a brief summary followed by a more detailed comment of the most important points, which is why the work is so exceptionally robust and valid. Any falsification, fabrication or manipulation of the data can therefore be ruled out:
1. The study was accompanied and monitored by the planning statistician with the help of the computer-aided randomization program Randomizer of the Medical University of Graz. This program automatically writes a protocol (= audit trail), so that every inclusion or exclusion process was recorded. Subsequent exclusion (‘post-hoc exclusion’) is therefore not possible, as every step has been monitored.
2. The authors, most of whom are not interested in homeopathy, had control of and access to the study data at all times.
3. The study was analysed in a four-stage procedure, which is unusual for an academic study: the data were entered into the tamper-proof Research, Documentation and Analysis (RDA) platform of the Medical University of Vienna, then forwarded by the planning statistician to the analysing statistician by means of an elaborate clearing process at the University. This quadruple evaluation check proves the extraordinary quality of the results.
We therefore confirm the reliability, veracity and accuracy of the data presented in our article published in The Oncologist.
Link to the study: https://doi.org/10.1002/onco.13548
More detailed comment available here
The Oncologist published am ‘expression of concern‘:
In August 2022, the journal editors received credible information from the Austrian Agency for Research Integrity about potential data falsification and data manipulation in this article. While The Oncologist editorial team investigates and communicates with the corresponding author, the editors are publishing this Expression of Concern to alert readers that, pending the outcome and review of a full investigation, the research results presented may not be reliable.
A seemingly endless discussion with many dozens of e-mails ensued with the journal editors and publishers who not only resisted all demands to withdraw the study, ignored the wishes of co-authors to have their name withdrawn, but eventually published a remarkably incompetent editorial more or less vindicating Frass and his dubious research. Our long and frustrating attempts to get the study withdrawn continued unabated.
Meanwhile the ÄRZTEGESELLSCHAFT FÜR KLASSISCHE HOMÖOPATHIE (ÄKH) and other homeopathic organisations celebrated Frass as their hero e.g.:
In 2020, an article appeared in the journal ‘The Oncologist’ about an RCT study in which Prof Dr Michael Frass and others had shown that homeopathic treatment as an add-on therapy can improve quality of life and prolong survival in patients with non-small cell lung cancer. Two years later, serious allegations were levelled against the research team. The authenticity of the study was questioned and there was talk of manipulation and fraud. Prof Michael Frass and his colleagues responded in writing and in detail to all the accusations, and the facts they presented were able to refute all the allegations – with the positive result that the journal ‘The Oncologist’ confirmed in September 2024 that it would not retract the article published in 2020. It rehabilitated Prof Frass and his team with an editorial confirming the value of the study. In addition, a revised S-3 guideline in May 2024 continued to list homeopathy as an optional recommendation for certain oncological patients. Our warmest congratulations!
In 2024, ‘Retraction Watch’ took on the issue and published the following summary thus far:
A paper that claimed to show a homeopathic intervention improved quality of life and survival for people with advanced lung cancer has received an extensive correction two years after a research integrity watchdog asked the journal to retract the article over concerns about manipulated data, Retraction Watch has learned.
The two scientists who sounded the alarm on the paper are not satisfied with the correction, they told us.
The article, “Homeopathic Treatment as an Add‐On Therapy May Improve Quality of Life and Prolong Survival in Patients with Non‐Small Cell Lung Cancer: A Prospective, Randomized, Placebo‐Controlled, Double‐Blind, Three‐Arm, Multicenter Study,” appeared in The Oncologist in November 2020. Michael Frass, the lead author of the paper, is a homeopathic practitioner who was working at the Medical University of Vienna, at the time the work was published.
The paper has been cited 18 times, according to Clarivate’s Web of Science, and was included in a German medical organization’s guideline about complementary treatment for cancer patients. Many homeopathy organizations posted about the study on X as evidence of the approach’s benefit, helping propel the article to the top 5% of all research articles for which Altmetric, a publication data company, has tracked online attention.
The article also attracted the notice of Norbert Aust, a retired mechanical engineer who started the Homeopathy Information Network in Germany, and Viktor Weisshäupl, a retired anesthesiologist now working on the Initiative for Scientific Medicine in Austria. The pair undertook an analysis of the study protocols and data posted to ClinicalTrials.gov.
They found several differences between the initial registration posted in January 2012, a protocol dated January 2011 but uploaded in July 2019, and the published paper. These differences included the number of participants, study arms, exclusion criteria, follow-up time, and cancer types included in the study. Aust and Weisshäupl also noted the study protocol said the software the authors used to analyze their data was a version not yet available in 2011.
“In conclusion, it seems likely that the substantial modifications of crucial study parameters that occurred after the study had been started and results had become available biased the results in favor of homeopathy,” Aust and Weisshäupl wrote in a description of their findings on Edzard Ernst’s blog in June 2021.
According to another article Aust and Weisshäupl published in Skeptical Inquirer in 2023, the pair reported their findings to the Medical University Vienna, which referred the matter to the Austrian Agency for Scientific Integrity.
In a report dated September 2022 and obtained by Retraction Watch, the Austrian watchdog said its investigation “found numerous manipulations,” and asked The Oncologist’s editor in chief Susan Bates to retract the article.
Among the findings:
- “The presentation of the study as double-blind placebo controlled is untrue.”
- “Substantial” changes to the study protocol while it was running, including to the primary endpoint, that were not mentioned in the publication, “suggestive of data manipulation.”
- “Many patients were excluded post-hoc, which is suggestive of data manipulation.”
- “Fully implausible” survival data, “compatible with selective deletion of records.”
- “The patients in the homeopathy group report a quality of life that is much higher than that of the general population known from other surveys. For patients with stage four non-small cell lung cancer this is highly implausible.”
The Oncologist published an expression of concern in October 2022 citing “credible information from the Austrian Agency for Research Integrity about potential data falsification and data manipulation in this article.”
“While The Oncologist editorial team investigates and communicates with the corresponding author, the editors are publishing this Expression of Concern to alert readers that, pending the outcome and review of a full investigation, the research results presented may not be reliable,” the notice stated.
On Tuesday, the journal published an extensive correction to the article, stating:
Additional details not included in the original publication have since been provided by the authors and reviewed by the editors to clarify these concerns. These omissions do not affect the results of this study.
Frass told us he and his team were “pleased that after a profound and thorough investigation by The Oncologist it has now been proven that the paper is correct. The Commission’s allegations are unsubstantiated and completely unfounded.” He provided a diagram he and a friend made which he said showed “all allegations could be refuted adequately.”
Along with the correction, the journal published an editorial by Bates and another editor describing how The Oncologist published the paper in a section dedicated to the results of clinical trials that might not otherwise be posted. It concluded:
The Oncologist and its CTR section hope that—by turning to the laboratory to determine whether any fraction of a homeopathic remedy holds a thread of promise—science identifies what is in these mixtures and that, in turn, potential anticancer compounds are then developed through conventional pathways.
We reached out to Bates for comment, and received the following response from a spokesperson for Oxford University Press, the journal’s publisher:
In 2022 The Oncologist received a letter about “Homeopathic Treatment as an Add-On Therapy May Improve Quality of Life and Prolong Survival in Patients with Non-Small Cell Lung Cancer: A Prospective, Randomized, Placebo-Controlled, Double-Blind, Three-Arm, Multicenter Study” from the Commission for Research Integrity of the Austrian Agency for Research Integrity (OeAWI) and the journal issued an expression of concern. The journal has since conducted a thorough investigation and based on guidelines from the Committee on Publication Ethics (COPE), determined that a correction is the appropriate response to the concerns raised. The accompanying editorial provides further context. The correction and editorial are the journal’s full response.
The correction doesn’t address the issues Aust, Weisshäupl, and the Austrian Agency for Scientific Integrity found with the study, Aust told us.
“They explain some trifles,” he said, “but the elephant in the room is not mentioned.” He also wondered why a letter to the editor he and Weisshäupl submitted in 2021 had not been published.
The editorial’s question of whether some components in the homeopathic intervention could be therapeutic “is completely irrelevant,” Aust said.
“If some results are obtained by data manipulation and falsification, then it is pointless to argue if there might have been some effect by the preparations that were administered,” he said. “The data are not valid and it is wrong, unethical and might cause harm for patients if they stay published like solid outcomes of some rigorous trial.”
Our continued efforts to get the Frass study withdrawn have been summarised on 16 October 2025 in a guest post by Victor Weisshäupl here on this blog. As of 27 October 2025, the journal still advertised the questionable study, albeit with three caveats:
But now, after almost 5 years of insistance on our part, there has been a new development: the awful study will be retracted! This news came first via the ÄKH; a few days ago, they published the following statement about it (my translation):
In October 2025, the study was once again attacked with arguments that were absurd from a homeopathic point of view, namely that Michael Frass had changed the dosage and potency during the treatment of the study patients and that he had used the same medicines in his practice as in the study (conflict of interest). Unfortunately, these arguments led to the study being withdrawn after all.
As Frass is the vice-president of the ÄKH, we can take this as indicating that Frass has been informed by OUP and/or The Oncologist that his paper is about to be withdrawn. So far so good! What is odd, however, is the reasons given for the decision. They were not the subject of our complaints! Most likely, this is yet anouther attempt of Frass to white-wash the findings of his ghastly study. We will know more as soon as an official retraction notice becomes available – so, me entitling this post “the end” might not be entirely correct.
WATCH THIS SPACE.
Indian researchers presented the case of a 52‑year‑old female patient diagnosed with Stage 4 metastatic cancer involving the lungs and bone marrow, confirmed by PET‑CT. Baseline symptoms included severe chest pain with heaviness, pain in the right parietal region, breathlessness, loss of appetite, weakness, and haemoglobin (Hb) of 6 g/dL.
The patient underwent three to four sessions per day (each ~30 minutes) of Copper Pendulum Therapy over a total of 35 days, without concurrent chemotherapy or radiotherapy. In case you are unfamiliar with this modality, here are a video and an article about it.
Sequential chest X‑rays demonstrated a ~40% improvement in lung field clarity and a ~45% reduction in pleural effusion. Hb levels improved from 6 to 8.2 g/dL and stabilised. EEG analysis revealed improved rhythmic stability in alpha and beta frequency bands, correlating with enhanced neurological function. Symptomatically, pain reduced, breathing improved, and appetite began to return.
The authors concluded that this case suggests that Copper Pendulum Therapy may contribute to measurable clinical, radiological, haematological, and neurological improvements in advanced cancer patients. Larger
studies are warranted to validate these findings.
No, I disagree, “larger studies” of copper pendulum therapy would be a mistake!
The authors report that “the patient had no concurrent chemotherapy, radiotherapy, or other conventional anticancer treatment at the time of presentation.” This wording implies that such treatments had been administered before presentation. If so, this could explain the outcome. Alternatively, we might have here a rare instance of spontaneous remission.
In any case, I suggest that the Copper Pendulum Therapy had nothing to do with the reported results. The authors, however, are convinced of the opposite which does not surprise me: they are affiliated to the Bharat Copper Therapy and Research Center (BCTRC), Nagpur, India. Despite this fact, they declare ” no conflict of interest”.
In case you wonder which journal pollutes the medical literature with such vile nonsense, it is the “International Journal of Scientific Development and Research“. It claims that it “aims to explore advances in research pertaining to applied, theoretical and experimental Technological studies. The goal is to promote scientific information interchange between researchers, developers, engineers, students, and practitioners working in and around the world.”
Really, “advances in research”?
More likely advances in pseudoscience, if you ask me.
- (1) SMT,
- (2) ambulatory ibuprofen prescription,
using propensity matching for OUD risk factors. The primary outcome was the risk ratio (RR) of OUD. The RR for long-term opioid use, and opioid prescription RR and mean count were also explored. Primary analyses conducted in TriNetX and R used logistic regression for matching, standardized mean difference to assess between-cohort balance (threshold of ≤ 0.1), and contingency tables for RRs, using a significance threshold of p < 0.05.
Robert F. Kennedy Jr. has stated that circumcised boys have double the rate of autism. He thus suggested this is “highly likely” because they are given Tylenol for pain after the procedure. His claim references this 2015 study published in the Journal of the Royal Society of Medicine:
Objective: Based on converging observations in animal, clinical and ecological studies, we hypothesised a possible impact of ritual circumcision on the subsequent risk of autism spectrum disorder (ASD) in young boys.
Design: National, register-based cohort study.
Setting: Denmark.
Participants: A total of 342,877 boys born between 1994 and 2003 and followed in the age span 0-9 years between 1994 and 2013.
Main outcome measures: Information about cohort members’ ritual circumcisions, confounders and ASD outcomes, as well as two supplementary outcomes, hyperkinetic disorder and asthma, was obtained from national registers. Hazard ratios (HRs) with 95% confidence intervals (CIs) associated with foreskin status were obtained using Cox proportional hazards regression analyses.
Results: With a total of 4986 ASD cases, our study showed that regardless of cultural background circumcised boys were more likely than intact boys to develop ASD before age 10 years (HR = 1.46; 95% CI: 1.11-1.93). Risk was particularly high for infantile autism before age five years (HR = 2.06; 95% CI: 1.36-3.13). Circumcised boys in non-Muslim families were also more likely to develop hyperkinetic disorder (HR = 1.81; 95% CI: 1.11-2.96). Associations with asthma were consistently inconspicuous (HR = 0.96; 95% CI: 0.84-1.10).
Conclusions: We confirmed our hypothesis that boys who undergo ritual circumcision may run a greater risk of developing ASD. This finding, and the unexpected observation of an increased risk of hyperactivity disorder among circumcised boys in non-Muslim families, need attention, particularly because data limitations most likely rendered our HR estimates conservative. Considering the widespread practice of non-therapeutic circumcision in infancy and childhood around the world, confirmatory studies should be given priority.
In other words, the study found that circumcised boys were more likely to be diagnosed with autism compared to others in the group. Kennedy asserts that the post-circumcision use of Tylenol is the causal factor, relating it to his broader, unproven theory that acetaminophen use in early childhood is linked to autism.
Yet, every 1st-year medical student would point out that the study demonstrated only a correlation, not a causation, between circumcision and autism. Critically, the researchers involved in the original Denmark study stated that they had no data on the use of painkillers or anesthetics during the procedure, meaning they could not address whether Tylenol was involved in the observed correlation.
Other subsequent, more rigorous studies have found no evidence to support a link between either circumcision or Tylenol use and autism. Numerous health organizations, including the Autism Society of America, have criticized Kennedy’s theorie as being unproven, misleading, and not based on scientific evidence.
PS
Mr Kennedy, if you are reading this (which would surprise me), here are a few further, well-documented correlations that you might find worthy of your pseudo-research interest:
- The per capita consumption of margarine is highly correlated with the divorce rate in Maine.
- There’s a strong correlation between the number of people who drowned by falling into a pool and the number of films in which Nicolas Cage has appeared.
- The number of doctoral degrees awarded in civil engineering correlates with the per capita consumption of mozzarella cheese.
- The amount of cheese consumed strongly correlates with the number of people who have died by becoming tangled in their bedsheets.
- The revenue generated by arcades is correlated with the number of computer science doctorates awarded.
- The per capita consumption of sour cream correlates with the number of motorcycle deaths in the U.S.
THANK YOU FOR YOUR ATTENTION IN THIS MATTER.
Consider the case of a women who is 3 months pregnant and develops a high and persistent fever (by no means a rare event). Her doctor diagnoses a strep throat and treats her with antibiotics. For lowering her temperature, he would normally have advised paracetamol (acetaminophen). After this was pronounced prohibitively dangerous, he has 3 options:
- Give no medicine for the fever.
- Give Aspirin.
- Give ibuprofen.
What are the risks involved in these three options?
1. Give no medicine for the fever
High or sustained fever, especially in the first trimester (which the patient is nearing the end of or just finished), has been associated with an increased risk of certain birth defects, including neural tube defects, heart defects, and cleft lip/palate.
2. Give Aspirin
The use of Aspirin during pregnancy, especially at higher doses (not the low dose often used for preeclampsia prevention), carries the following risks:
- Higher doses of aspirin during early pregnancy raise the risk of pregnancy loss and congenital defects.
- Higher doses of aspirin are also associated with premature closure of the ductus arteriosus (a fetal heart vessel), fetal kidney problems, and increased bleeding risk for both mother and baby.
Low-dose aspirin is considered safe but may not affect the fever.
3. Give Ibuprofen
- Some studies suggest an increased risk of miscarriage, if taken around conception or over a long period, though evidence is conflicting.
- Ibuprofen is contraindicated in the third trimester (after 28 weeks) due to the risk of fetal renal dysfunction, premature closure of the ductus arteriosus or inhibition of uterine contractions.
What are the consequences?
One can extrapolate that an adherence to a “no paracetamol” policy to treat fever in pregnancy would likely have the following effects in the US:
- Over a thousand additional severe birth defects per year that might have been prevented by safely treating a high fever, especially in the first trimester.
- Many thousands of additional cases of preterm labor/delivery caused by untreated maternal fever later in pregnancy.
- A significant increase in the use of the riskier medicines such as ibuprofen or Aspirin which are associated with fetal risks, leading to hundreds of new cases of fetal kidney and cardiac issues.
In other words, persuading pregnant women to forgo the safest, most effective fever reducer would cause thousands of severe, preventable fetal adverse outcomes per year. This would far outweigh the unproven or even disproven risk of autism from short-term, appropriate paracetamol use.
For many years, I have fought aginst the looming age of unreason in healthcare. Now it seems more and more clear to me that the age of unreason is upon us – not merely in the realm of healthcare but in all spheres of life.
- The world’s foremost conman tells the UN assembly that climate change is a con.
- As though that is not bad enough, the delegates do not even get up and leave the room in protest.
- RFKJr tells the world that paracetamol is the cause of autism, thus contradicting the best available evidence.
- As though that is not bad enough, he also announces that leucovorin is the cure, thus contradicting the best available evidence..
- In Germany, the country that only a few decades ago committed unprecedented crimes against humanity in the name of Nazi ideology, larger and larger sections again vote for Nazis.
- In the UK, Nigel Farage who nearly ruined the country wth his Brexit, is now a serious contender for the post of PM.
- A US celebrity fascist is assassinated and instantly becomes a national hero.
- A US TV-host suggests to euthanize all homeless people.
- Another one says the UN building should be bombed.
- Trump insists that Zelensky started the war with Russia.
- The Indian AYUSH ministry promotes homeopathy as a treatment for COVID and other serious diseases.
- RFKJr believes that vaccinations do more harm than good and elevates this notion to a political movement.
These are just a few specific examples form an almost endless pool of options. They serve to support the more general arguments suggesting that the age of unreason is indeed upon us. These are based on a long list of inter-related phenomena (in no particular order):
- Proliferation of deliberate misinformation.
- Disregard for verifiable evidence by political figures and many others.
- Prioritization of strongly held personal feelings or emotions above reasoned deliberation or dispassionate analysis.
- Widespread distrust towards established institutions and experts.
- Rejection of consensus knowledge.
- Failure to equip citizens with the necessary skills to evaluate sources and discern bias.
- Headline-driven nature of modern communication.
- Immediate emotional reaction over in-depth and considered analysis.
- Widespread acceptance of irrational conspiracy theories.
- Public embrace of anti-intellectual attitudes.
- Proliferation of bullshit.
So, is the age of unreason upon us?
Please decide for yourself.
As predicted in my post yesterday, Donald Trump, Mehmet Oz and Robert F Kennedy Jr made an announcement on Monday at the White House, advising pregnant women to avoid taking paracetamol and claiming that it heightens the risk of autism. As pointed out in yesterday’s post, this assertion is not based on reliable evidence.
Specifically, like a trio of charlatans, they misled the public by claiming that the use of paracetamol during pregnancy is linked to autism and that the US Food and Drug Administration (FDA) would be advising doctors to minimize its use. Also as predicted, they promoted leucovorin as an autism treatment, a claim equally not supported by reliable evidence. Finally, Trump repeated long-debunked claims that ingredients in vaccines or timing shots close together could contribute to rising rates of autism in the U.S., without providing any medical evidence.
Several medical organizations, including the American College of Obstetricians and Gynecologists (ACOG) and the American Academy of Pediatrics, swiftly condemned these statements as “irresponsible” and not backed by sound scientific evidence. They emphasized that a causal link between paracetamol and autism has not been established. New York University bioethicist Art Caplan said it was “the saddest display of a lack of evidence, rumors, recycling old myths, lousy advice, outright lies, and dangerous advice I have ever witnessed by anyone in authority.” Health regulators in other countries, such as the UK and Australia, also reiterated their guidance that paracetamol is safe for use during pregnancy. The overwhelming consensus among the global scientific community is that paracetamol remains the safest pain relief option for pregnant women when used as directed. Untreated pain and fever during pregnancy can pose more significant risks to both the mother and the unborn baby.
Dr. Mehmet Oz, who is of course well-known for making millions by promoting every form of quackery on the planet, discussed the decision to have government health programs like Medicaid and the Children’s Health Insurance Program (CHIP) cover the cost of leucovorin, i.e. folinic acid, for the treatment of autism. He stated that this move would ensure access to the drug for millions of children and that he expected private insurance companies to follow suit. Yet, the use of leucovorin for autism is considered highly controversial, as pointed out in yesterday’s post. It is not widely accepted by the scientific community and, if effective at all, can work only for a small sub-set of autistic patients. Even for them, it is not a cure and would only be helpful for certain symptoms.
So, why mislead the public in this way?
One reason could be that the company, “iHerb” for which Mehmet Oz is “Global Advisor & Stakeholder”, sells no less than 4 supplements with a version of leucovorin. The announcement from the White House and the administration’s push for the drug therefore raise serious questions and concerns about conflicts of interest and corruption.
