MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

bias

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Chinese researchers evaluated the effect of Chinese medicine (CM) on survival time and quality of life (QoL) in patients with small-cell lung cancer (SCLC). They conducted an exploratory and prospective clinical observation. Patients diagnosed with SCLC receiving CM treatment as an add-on to conventional cancer therapies were included and followed up every 3 months. The primary outcome was overall survival (OS), and the secondary outcomes were progression-free survival (PFS) and QoL.

A total of 136 patients including 65 limited-stage SCLC (LS-SCLC) patients and 71 extensive-stage SCLC (ES-SCLC) patients were analyzed. The median OS of ES-SCLC patients was 17.27 months, and the median OS of LS-SCLC was 40.07 months. The survival time was 16.27 months for SCLC patients with brain metastasis, 9.83 months for liver metastasis, 13.43 months for bone metastasis, and 18.13 months for lung metastasis. Advanced age, pleural fluid, liver, and brain metastasis were risk factors, while longer CM treatment duration was a protective factor. QoL assessment indicated that after 6 months of CM treatment, scores increased in function domains and decreased in symptom domains.

The authors concluded that CM treatment might help prolong OS of SCLC patients. Moreover, CM treatment brought the trend of symptom amelioration and QoL improvement. These results provide preliminary evidence for applying CM in SCLC multi-disciplinary treatment.

Sorry, but these results provide NO evidence for applying CM in SCLC multi-disciplinary treatment! Even if the findings were a bit better than those reported for SCLC in the literature – and I am not sure they are – it is simply not possible to say with any degree of certainty what effect the CM had. For that, we would obviously need a proper control group.

The study was supported by the National Natural Science Foundation of China (No. 81673797), and Beijing Municipal Natural Science Foundation (No. 7182142). In my view, this paper is an example for showing how the relentless promotion of dubious Traditional Chinese Medicine by Chinese officials might cost lives.

I feel that it is time to do something about it.

But what precisely?

Any ideas anyone?

 

Prof Harald Walach has had a few rough weeks. First, he published his paper suggesting that Covid vaccinations do more harm than good which was subsequently retracted as flawed, if not fraudulent. Next, he published a paper showing that children are put in danger when wearing face masks suggesting that “decision-makers weigh the hard evidence produced by these experimental measurements accordingly, which suggest that children should not be forced to wear face masks.” Now, the journal put out the following announcement about it:

The Research Letter, “Experimental Assessment of Carbon Dioxide Content in Inhaled Air With or Without Face Masks in Healthy Children: A Randomized Clinical Trial,” by Harald Walach, PhD, and colleagues published online in JAMA Pediatrics on June 30, 2021,1 is hereby retracted.

Following publication, numerous scientific issues were raised regarding the study methodology, including concerns about the applicability of the device used for assessment of carbon dioxide levels in this study setting, and whether the measurements obtained accurately represented carbon dioxide content in inhaled air, as well as issues related to the validity of the study conclusions. In their invited responses to these and other concerns, the authors did not provide sufficiently convincing evidence to resolve these issues, as determined by editorial evaluation and additional scientific review. Given fundamental concerns about the study methodology, uncertainty regarding the validity of the findings and conclusions, and the potential public health implications, the editors have retracted this Research Letter.

To make things even worse, Walach’s University fired him because of his fraudulent anti-vax research. Poznan University of Medical Sciences tweeted on 6 July:

We wish to emphasize that the claims included in dr Harald Walach’s recent article in @Vaccines_MDPI do not represent the position of @PUMS_tweets . We find that the article lacked scientific diligence and proper methodology. Dr. Walach’s affiliation with PUMS was now terminated. Throughout the pandemic PUMS has actively promoted vaccination programs, offering scientific expertise in the media, broadcasting seminars, and reported on progress of the vaccination program. We consider vaccinations as the paramount tool in the global fight against the pandemic. We consider vaccinations as the paramount tool in the global fight against the #pandemic. Over 85% of our own academic community has already been vaccinated with support and encouragement from the University.

As I said, this is truly unlucky …

.. or perhaps not?

Come to think of it, it is lucky when pseudo-science and fraud are called out. It means that the self-cleaning mechanisms of science are working and we are protected from the harm done by charlatans.

Recently, I received this comment from a reader:

Edzard-‘I see you do not understand much of trial design’ is true BUT I wager that you are in the same boat when it comes to a design of a trial for LBP treatment: not only you but many other therapists. There are too many variables in the treatment relationship that would allow genuine , valid criticism of any design. If I have to pick one book of the several listed elsewhere I choose Gregory Grieve’s ‘Common Vertebral Joint Problems’. Get it, read it, think about it and with sufficient luck you may come to realize that your warranted prejudices against many unconventional ‘medical’ treatments should not be of the same strength when it comes to judging the physical therapy of some spinal problems as described in the book.

And a chiro added:

EE: I see that you do not understand much of trial design

Perhaps it’s Ernst who doesnt understand how to research back pain.

“The identification of patient subgroups that respond best to specific interventions has been set as a key priority in LBP research for the past 2 decades.2,7 In parallel, surveys of clinicians managing LBP show that there are strong views against generic treatment and an expectation that treatment should be individualized to the patient.6,22.”

Journal of Orthopaedic & Sports Physical Therapy
Published Online:January 31, 2017Volume47Issue2Pages44-48

Do I need to explain why the Grieve book (yes, I have it and yes, I read it) is not a substitute for evidence that an intervention or technique is effective? No, I didn’t think so. This needs to come from a decent clinical trial.

And how would one design a trial of LBP (low back pain) that would be a meaningful first step and account for the “many variables in the treatment relationship”?

How about proceeding as follows (the steps are not necessarily in that order):

  • Study the previously published literature.
  • Talk to other experts.
  • Recruit a research team that covers all the expertise you need (and don’t have yourself).
  • Formulate your research question. Mine would be IS THERAPY XY MORE EFFECTIVE THAN USUAL CARE FOR CHRONIC LBP? I know LBP is but a vague symptom. This does, however, not necessarily matter (see below).
  • Define primary and secondary outcome measures, e.g. pain, QoL, function, as well as the validated methods with which they will be quantified.
  • Clarify the method you employ for monitoring adverse effects.
  • Do a small pilot study.
  • Involve a statistician.
  • Calculate the required sample size of your study.
  • Consider going multi-center with your trial if you are short of patients.
  • Define chronic LBP as closely as you can. If there is evidence that a certain type of patient responds better to the therapy xy than others, that might be considered in the definition of the type of LBP.
  • List all inclusion and exclusion criteria.
  • Make sure you include randomization in the design.
  • Randomization should be to groups A and B. Group A receives treatment xy, while group B receives usual care.
  • Write down what A and B should and should not entail.
  • Make sure you include blinding of the outcome assessors and data evaluators.
  • Define how frequently the treatments should be administered and for how long.
  • Make sure all therapists employed in the study are of a high standard and define the criteria of this standard.
  • Train all therapists of both groups such that they provide treatments that are as uniform as possible.
  • Work out a reasonable statistical plan for evaluating the results.
  • Write all this down in a protocol.

Such a trial design does not need patient or therapist blinding nor does it require a placebo. The information it would provide is, of course, limited in several ways. Yet it would be a rigorous test of the research question.

If the results of the study are positive, one might consider thinking of an adequate sham treatment to match therapy xy and of other ways of firming up the evidence.

As LBP is not a disease but a symptom, the study does not aim to include patients that all are equal in all aspects of their condition. If some patients turn out to respond better than others, one can later check whether they have identifiable characteristics. Subsequently, one would need to do a trial to test whether the assumption is true.

Therapy xy is complex and needs to be tailored to the characteristics of each patient? That is not necessarily an unsolvable problem. Within limits, it is possible to allow each therapist the freedom to chose the approach he/she thinks is optimal. If the freedom needed is considerable, this might change the research question to something like ‘IS THAT TYPE OF THERAPIST MORE EFFECTIVE THAN THOSE EMPLOYING USUAL CARE FOR CHRONIC LBP?’

My trial would obviously not answer all the open questions. Yet it would be a reasonable start for evaluating a therapy that has not yet been submitted to clinical trials. Subsequent trials could build on its results.

I am sure that I have forgotten lots of details. If they come up in discussion, I can try to incorporate them into the study design.

 

 

Acupuncture is a veritable panacea; it cures everything! At least this is what many of its advocates want us to believe. Does it also have a role in supportive cancer care?

Let’s find out.

This systematic review evaluated the effects of acupuncture in women with breast cancer (BC), focusing on patient-reported outcomes (PROs).

A comprehensive literature search was carried out for randomized controlled trials (RCTs) reporting PROs in BC patients with treatment-related symptoms after undergoing acupuncture for at least four weeks. Literature screening, data extraction, and risk bias assessment were independently carried out by two researchers. The authors stated that they followed the ‘Preferred Reporting Items for Systematic Review and Meta-Analyses’ (PRISMA) guidelines.

Out of the 2, 524 identified studies, 29 studies representing 33 articles were included in this meta-analysis. The RCTs employed various acupuncture techniques with a needle, such as hand-acupuncture and electroacupuncture. Sham/placebo acupuncture, pharmacotherapy, no intervention, or usual care were the control interventions. About half of the studies lacked adequate blinding.

At the end of treatment (EOT), the acupuncture patients’ quality of life (QoL) was measured by the QLQ-C30 QoL subscale, the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES), the Functional Assessment of Cancer Therapy–General/Breast (FACT-G/B), and the Menopause-Specific Quality of Life Questionnaire (MENQOL), which depicted a significant improvement. The use of acupuncture in BC patients lead to a considerable reduction in the scores of all subscales of the Brief Pain Inventory-Short Form (BPI-SF) and Visual Analog Scale (VAS) measuring pain. Moreover, patients treated with acupuncture were more likely to experience improvements in hot flashes scores, fatigue, sleep disturbance, and anxiety compared to those in the control group, while the improvements in depression were comparable across both groups. Long-term follow-up results were similar to the EOT results. Eleven RCTs did not report any information on adverse effects.

The authors concluded that current evidence suggests that acupuncture might improve BC treatment-related symptoms measured with PROs including QoL, pain, fatigue, hot flashes, sleep disturbance and anxiety. However, a number of included studies report limited amounts of certain subgroup settings, thus more rigorous, well-designed and larger RCTs are needed to confirm our results.

This review looks rigorous on the surface but has many weaknesses if one digs only a little deeper. To start with, it has no precise research question: is any type of acupuncture better than any type of control? This is not a research question that anyone can answer with just a few studies of mostly poor quality. The authors claim to follow the PRISMA guidelines, yet (as a co-author of these guidelines) I can assure you that this is not true. Many of the included studies are small and lacked blinding. The results are confusing, contradictory and not clearly reported. Many trials fail to mention adverse effects and thus violate research ethics, etc., etc.

The conclusion that acupuncture might improve BC treatment-related symptoms could be true. But does this paper convince me that acupuncture DOES improve these symptoms?

No!

Regular readers of this blog will know the US homeopath, Dana Ullman. He has been the star of several of my posts (for instance here, here, and here). Dana is prolific in his writing but he has published not published much in proper journals. Now he has almost doubled this list by publishing TWO (!) proper papers in real journals within just one month.

Congratulations, Dana!

The first is in CUREUS, a very unusual journal with a most unusual peer-review process. Allow me to show you the abstract of Dana’s article:

Homeopathic medicine is a controversial system of medicine that has been used worldwide for over 200 years. Recently, several governments, in part, owing to government-funded reviews of research on homeopathic medicine, have stopped reimbursements for homeopathic medicines and have discouraged their use by medical professionals. This review critically evaluates four government-funded reviews of clinical research on homeopathic medicine. An analysis of government-sponsored reviews of clinical research on homeopathic medicine was conducted, including two studies from Switzerland, one from England, and one from Australia. Three of the four government-funded reviews were critical of homeopathy, claiming that there was no reliable evidence that homeopathic medicines were effective. Three of these reviews had significant flaws, with potential ethical concerns raised in one of the reviews. The most comprehensive review of homeopathic research, including analysis of clinical and basic science concerns, found the most positive results for homeopathy.

The second paper was published in a journal called DOSE RESPONSE. The editor in chief of this journal is Prof E J Calabrese who has published numerous articles about homeopathy/hormesis. Here is the abstract of Dana’s 2nd article:

Serially diluted succussed solutions of a suitable drug/toxic substance can exhibit physicochemical and biological properties even far beyond Avogadro’s limit defying conventional wisdom. They can show hormesis, and homeopathy uses them as medicines. Many studies confirm that they can have an impact on gene expression different than controls. Water in the exclusion zone phase can have memory but for a short period. However, the nanoparticle as the physical substrate can hold information. Nanoparticle and exclusion zone duo as nanoparticle-exclusion zone shell can provide a prolonged memory. The Nanoparticle-Exclusion Zone Shell Model may be an important step toward explaining the nature and bioactivity of serially diluted succussed solutions used as homeopathic medicines. This model may also provide insight into the workings of hormesis. Hormesis is the primary phenomenon through which homeopathic phenomenon may have evolved exhibiting the principle of similars. Hahnemann exploited it to establish homeopathy. The nanoparticle-exclusion zone shells present in the remedy, selected on the principle of similars, can be patient-specific nanoparticles in a symptom syndrome-specific manner. They can carry the drug-specific information for safer clinical applications in an amplified form for high yielding. It suggests homeopathy is a type of nanopharmacology.

So, are Dana’s two articles significant? Both are reviews. The 1st tries to persuade us that homeopathy has clinical effects beyond placebo and that reports that say otherwise are full of errors and fraud and thus not reliable. The second tells us that these clinical effects of homeopathy can be explained by nano-pharmacology.

Is he right?

Please tell me what you think.

We have discussed Marma massage, we have repeatedly discussed acupuncture, of course, but we have so far never considered marmapuncture. The ‘British Institute of Marmapuncture‘ explains what it is:

Marmapuncture is traditionally known as Bhedan karma (meaning the action of piercing through) is a time tested therapeutic intervention, which treats the energetic body through an elaborate network of channels known as srotas.

Despite the widely held belief that Marmapuncture is a derivative of Chinese Acupuncture, that was popularised in 200-400 BC in text of the Yellow Emperor) modern archaeological evidence points to the fact that Suchi Bhaden, Shira Bhedan and Bhadhan Karma where practised in Sri Lanka well before this time. Finds discovered in caves in the Balangoda region of Sri Lanka, suggest there has been continuous habitation for over 37,000 years. Micro lithic tools were crafted from flint, fish bones and a type of rock known as Chert. These where used to penetrate the skin, which affected a therapeutic response in the body.

Another website informs us what marmapuncture can achieve:

Marmapuncture can relieve a wide range of symptoms associated with musculoskeletal pain or injury, chronic fatigue, bowel complaints (IBS) and indigestion, stress, depression, anxiety, panic attacks, skin complaints, asthma and breathing disorders, low/excessive appetite and infertility (male and female).

And why do I mention all this? Last weekend, I read the Guardian (3/7/2021) and there it was: a half-page article entitled MARMAPUNCTURE. THIS INNOVATIVE FACIAL TREATMENT IS MORE THAN SKIN DEEP. WE FIND OUT HOW IT IS USED IN AYURVEDIC MEDICINE AND PUT IT TO THE TEST. In the article, Mattie Lacey-Davidson had the treatment and found that marmapuncture (dubbed ‘natural Botox’) is not truly comparable to botox. Then Mattie mentioned a 2013 study that allegedly reported ‘promising results as a therapy for facial elasticity with evidence of skin tightening across the face’. I think I found the study; here it is:

Background. The use of acupuncture for cosmetic purposes has gained popularity worldwide. Facial cosmetic acupuncture (FCA) is applied to the head, face, and neck. However, little evidence supports the efficacy and safety of FCA. We hypothesized that FCA affects facial elasticity by restoring resting mimetic muscle tone through the insertion of needles into the muscles of the head, face, and neck. Methods. This open-label, single-arm pilot study was implemented at Kyung Hee University Hospital at Gangdong from August through September 2011. Participants were women aged 40 to 59 years with a Glogau photoaging scale III. Participants received five treatment sessions over three weeks. Participants were measured before and after FCA. The primary outcome was the Moire topography criteria. The secondary outcome was a patient-oriented self-assessment scale of facial elasticity. Results. Among 50 women screened, 28 were eligible and 27 completed the five FCA treatment sessions. A significant improvement after FCA treatment was evident according to mean change in Moire topography criteria (from 1.70 ± 0.724 to 2.26 ± 1.059, P < 0.0001). The most common adverse event was mild bruising at the needle site. Conclusions. In this pilot study, FCA showed promising results as a therapy for facial elasticity. However, further large-scale trials with a controlled design and objective measurements are needed.

As we see, it is neither a study of marmapuncture or a controlled trial. Its results are utterly meaningless. But is there any evidence at all to support the many claims made for marmapuncture?

No!

Last question: who is Mattie Lacey-Davidson?

She is a blogger/influencer/content creator based in London.

Say no more!

It was recently reported that about one-third of people who had been infected with COVID report suffering from long COVID:

  • Some 37% of people experienced at least one symptom lasting 12 weeks or more
  • Almost 15% said they had three or more symptoms for at least 12 weeks
  • Long-term problems were more common in women, and with increasing age
  • Higher weight, smoking, lower incomes, having a chronic illness, and having been hospitalized with Covid were linked to a higher chance of experiencing long-lasting symptoms
  • Tiredness was one of the most common symptoms, and in people who were severely ill with Covid, shortness of breath was a dominant long-lasting symptom

These are worrying figures indeed. Common symptoms of ‘long COVID’ include persistent breathlessness, fatigue, and cough; less common symptoms are chest pain, palpitations, neurological and cognitive deficits, rashes, and gastrointestinal dysfunction. Several research papers describe abnormalities confirming pathophysiological damage ranging from abnormal blood tests to organ damage seen on MRI imaging or in postmortem findings.

Yes, there are good reasons to be worried. Yet others might see this situation as an opportunity. One does not need to be clairvoyant to predict that, in so-called alternative medicine (SCAM), long-COVID will be the next big thing. Whenever there is a new, common, difficult-to-treat condition, SCAM practitioners and SCAM entrepreneurs fall over themselves claiming that their therapy is the solution. Gwyneth Paltrow’s bizarre was one of the first with her methods of easing long Covid symptoms. The Hollywood star and snake oil saleswoman said she had embarked on a “keto and plant-based” regime on the advice of an alternative medicine doctor. And, of course, it did her a world of good … Gwyneth approves of anything that is alternative.

On Medline, we already find an abundance of articles such as this one:

There is currently no drug or therapy that can cure the coronavirus disease 2019 (COVID-19), which is highly contagious and can be life-threatening in severe cases. Therefore, seeking potential effective therapies is an urgent task. An older female at the Leishenshan Hospital in Wuhan, China, with a severe case of COVID-19 with significant shortness of breath and decrease in peripheral oxygen saturation (SpO2), was treated using manual acupuncture and Chinese herbal medicine granule formula Fuzheng Rescue Lung with Xuebijing Injection in addition to standard care. The patient’s breath rate, SpO2, heart rate, ratio of neutrophil/lymphocyte (NLR), ratio of monocyte/lymphocyte (MLR), C-reactive protein (CRP), and chest computed tomography were monitored. Acupuncture significantly improved the patient’s breathing function, increased SpO2, and decreased her heart rate. Chinese herbal medicine might make the effect of acupuncture more stable; the use of herbal medicine also seemed to accelerate the absorption of lung infection lesions when its dosage was increased. The combination of acupuncture and herbs decreased NLR from 14.14 to 5.83, MLR from 1.15 to 0.33 and CRP from 15.25 to 6.01 mg/L. These results indicate that acupuncture and Chinese herbal medicine, as adjuvants to standard care, might achieve better results in treating severe cases of COVID-19.

A telephone survey included 495 COVID patients in India. 26% of them said they had people used 161 SCAM products and home remedies during and after COVID infections. More than half of the participants (59.6%) among them had consumed Ayurvedic Kadha. Many respondents consumed more than one SCAM product or home remedy.

A recent review evaluated the effect of SCAM on COVID patients. A total of 14 studies performed on 972 COVID patients were included. The results suggested that different SCAM interventions (acupuncture, Traditional Chinese medicine [TCM], relaxation, Qigong) significantly improved various psychological symptoms (depression, anxiety, stress, sleep quality, negative emotions, quality of life) and physical symptoms (inflammatory factors, physical activity, chest pain, and respiratory function) of COVID patients. The authors concluded that various SCAM interventions have a positive effect on improving the various dimensions of coronavirus disease but since there are few studies in this regard, further studies using different CAM approaches are recommended.

This conclusion is, of course, pure wishful thinking; the available evidence is in fact more than flimsy, and claims of effectiveness are not justified. But will this stop SCAM enthusiasts to make such claims? I fear not. My prediction is that, as this homeopath already indicated, they will see COVID as an opportunity: For homeopathy, shunned during its 200 years of existence by conventional medicine, this outbreak is a key opportunity to show potentially the contribution it can make in treating COVID-19 patients. 

 

This study assessed the effects of being born under the zodiac sign Pisces on mortality. For that purpose, a retrospective observational study was conducted of the data from 26 Scandinavian intensive care units between 2009 and 2011. Patients aged 18 years or older with severe sepsis and in need of fluid resuscitation were included from the Scandinavian Starch for Severe Sepsis/ Septic Shock (6S) trial. The main outcome measure was the 90-day mortality.

The researchers included all 798 patients in the study; 70 (9%) of them were born under the sign of Pisces. The primary outcome (death within 90 days) occurred in 25 patients (35.7%) in the Pisces group, compared with 348 patients (48%) in the non-Pisces group (relative risk, 0.75; 95% CI, 0.54-1.03; one-sided P = 0.03).

The authors concluded that in a multicentre randomised clinical trial of IV fluids, being born under the sign of Pisces was associated with a decreased risk of death. Our study shows that with convenient use of statistics and an enticing explanatory hypothesis, it is possible to achieve significant findings in post-hoc analyses of data from large trials.

This is an excellent paper! It showcases the sort of nonsense one can do with datasets, statistics, and post hoc hypotheses. The authors entitled their article “Gone fishing in a fluid trial”, and this title should ensure that there are not some astrology nutters who mistake correlation for causation

… I hope

… but, of course, I am an optimist.

Prof Harald Walach is well-known to regular readers of this blog (see, for instance, here, here, and here). Those who are aware of his work will know that he is not an expert in infectious diseases, epidemiology, virology, or vaccinations. This did not stop him to publish an analysis that questions the safety and rationale of the current COVID-19 vaccination programs. Here is the abstract:

COVID-19 vaccines have had expedited reviews without sufficient safety data. We wanted to compare risks and benefits.

Method: We calculated the number needed to vaccinate (NNTV) from a large Israeli field study to prevent one death. We accessed the Adverse Drug Reactions (ADR) database of the European Medicines Agency and of the Dutch National Register (lareb.nl) to extract the number of cases reporting severe side effects and the number of cases
with fatal side effects.

Result: The NNTV is between 200–700 to prevent one case of COVID-19 for the mRNA vaccine marketed by Pfizer, while the NNTV to prevent one death is between 9000 and 50,000 (95% confidence interval), with 16,000 as a point estimate. The number of cases experiencing adverse reactions has been reported to be 700 per 100,000 vaccinations. Currently, we see 16 serious side effects per 100,000 vaccinations, and the number of fatal side effects is at 4.11/100,000 vaccinations. For three deaths prevented by vaccination we have to accept two inflicted by vaccination.

Conclusions: This lack of clear benefit should cause governments to rethink their vaccination policy.

I hesitate to comment because some could think that I have a personal grudge, as Walach propagated lies about me. And crucially, like he, I am not a vaccination expert. Yet, I feel I ought to point out that the data that form the basis of Walach’s calculations should not be used in this way for at least two reasons.

  1. Death after vaccination does not mean that this event was caused by the vaccine. For example, if someone had a fatal accident after vaccination, it would count as a vaccine incident according to Walach’s calculation.
  2. Vaccine effectiveness cannot be measured by calculating how many people must receive a vaccine to prevent one case of COVID-19 vaccination. Since vaccines have a protective effect on the community, this would be an outright miscalculation. The more people who receive a vaccine, the fewer people need to receive it to prevent a single case. This situation is the exact opposite of what Walach assumes in his paper.

Conclusion: amongst all his previous nonsense, Walach’s new publication stands out, I feel, as the most stupid and the most dangerous. The mistakes seem too obvious to not be deliberate. Let’s hope the journal editor in chief (who failed miserably when publishing this idiocy) has the wisdom to retract it swiftly. One of its editors already tweeted:

I have resigned from the Editorial Board of

following the publication of this article. It is grossly negligent and I can’t believe it passed peer-review. I hope it will be retracted.

And another ed-board member had this to say:

In the UK, a new post-Brexit regulatory framework is being proposed for food supplements by the government. The nutraceutical sector is estimated to be worth £275bn globally and £4bn in the UK.  A new report claims that “science is starting to point the way to a new sector of nutritional products with increasingly explicable and/or verifiable medicinal benefits, which needs to be reflected in our regulatory framework.” Tory MP George Freeman, one of the authors of the report, was quoted saying:

“We are living through an extraordinary period of technological change – not just in life science but in host of sectors: from AI to robotics to agri-tech, nutraceuticals, nanotechnology, synthetic biology, biofuels, satellites and fusion energy. The UK is indeed a ‘science superpower’. But we have traditionally been woeful at commercialising here in the UK. There are many reasons. But, in recent years, the EU’s increasingly slow, bureaucratic and ‘precautionary’ approach – copied in Whitehall – has made the EU and the UK an increasingly poor place to commercialise new technology.”

If a product like a food or a herbal remedy makes ‘medicinal’ claims, it is currently regulated by the MHRA. If a product only makes general ‘health’ claims, it is regulated by the Department of Health and Social Care in England, by the FSA in Wales and Northern Ireland, and by Food Standards Scotland in Scotland. This ‘patchwork of regulators’ is bound to change as it is deemed to create additional costs and uncertainty for businesses who would like to see the relevant functions brought together in a central regulatory body and a clearer UK landscape.

In response to the task force’s report, PM Boris Johnson stated that bold and ambitious ideas such as these are needed to encourage growth and innovation:

“The Government, through our Better Regulation Committee, is already hard at work on reform of the UK’s regulatory framework. Your bold proposals provide a valuable template for this, illustrating the sheer level of ambitious thinking needed to usher in a new golden age of growth and innovation right across the UK. So we will give your report the detailed consideration it deserves, consult widely across industry and civil society, and publish a response as soon as is practicable.”

Am I the only one who feels more than a little uneasy about all this? I honestly do not see much new science that, according to the report, points to ‘verifiable medicinal benefits’ of food supplements or nutraceuticals. What the report does however point to, I fear, is that the UK government is about to deregulate quackery with a view to making some entrepreneurs wealthy snake oil salesmen at the cost of public health and wealth.

I hope I am mistaken.

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