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

patient choice

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For all of you who, like myself, like the occasional glass or two of wine:

THERE IS GOOD NEWS!

Wine is the latest alternative measure against COVID-19.

This, at least, is what an article sent to me seems to suggest:

At the end of the year, American researchers showed in-vitro that polyphenols in grapes and wine disrupt the way the Sars-Cov2 virus that causes Covid-19 replicates and spreads.

The Taiwan Medical University found that the tannins in wine effectively inhibit the activity of two key enzymes of the virus, which can no longer penetrate cell tissue.

“Of all the natural compounds we have tested in the laboratory, tannic acid is the most effective,” said Mien-Chie Hung, a molecular biologist and president of the university, on TVBS. He also recalled the good results obtained with experimental tannic acid treatments in 2003 during the SARS pandemic.

Now I understand why I haven’t caught the bug yet, I thought to myself, while pouring a large glass of red Bordeaux, my favorite. After yet another glass, I began to feel bad. No, not because of an alcohol overdose. Because I omitted something that might be not unimportant: I should really have told you who sent me the article. It was a source entirely devoted to the promotion of wine, a source related to my wine merchant.

Ah well, I thought, pouring a further glass.

When, many hours later, I had finally sobered up, I decided to conduct a few Medline searches. This is when I found this:

Greatly encouraged, I poured another glass.

 

 

 

PS

As, in my experience, COVID deniers are not the brightest buttons in the drawer, I should point out that THIS POST IS MEANT TO BE SATIRE.

Guest post by Tobias Katz

What do we know?

ICU admission

Taken from the BMJ (Ref 1): ICNARC latest report 31/12/21 showed that the proportion of patients admitted to critical care in December 2021 with confirmed covid-19 who were unvaccinated was 61%.

Prevention of infection

The government’s week 45 Covid surveillance report (Ref 3) is clear that vaccination prevention of infection (positive PCR, for Delta) effectiveness is estimated at 65% for Oxford-AstraZeneca and 80% for Pfizer.

Prevention of transmission

The Lancet’s (Ref 4) paper, suggests once infected, initial viral load is similar for vaccinated and unvaccinated individuals, suggesting likely equal chance of transmitting on the virus.

Protection of the individual

Ref 3, is clear cut that vaccination protects individuals from hospitalisation and severe infection (for Delta).

(Omicron) “Among those who had received 2 doses of AstraZeneca, there was no effect against Omicron from 20 weeks after the second dose. Among those who had received 2 doses of Pfizer or Moderna effectiveness dropped from around 65-70% down to around 10% by 20 weeks after the 2nd dose. 2 to 4 weeks after a booster dose vaccine effectiveness ranged from around 65 to 75%, dropping to 55 to 70% at 5 to 9 weeks and 40-50% from 10+ weeks after the booster.” (Ref 2)

Effectiveness here is measured by admission to hospital and shows the necessity for booster jabs when fighting Omicron.

Who are Dr James and Dr Malhotra?

Steven James, consultant anaesthetist, has recently been in the news for confronting Sajid Javid RE mandatory vaccinations for hospital and nursing staff. “The science isn’t strong enough” to support the policy he stated and “I’ve got antibodies”, suggesting that he’s as protected as he would be if he had a vaccine.

Aseem Malhotra, who goes by the name of ‘lifestylemedicinedoctor’ on Instagram is an extremely controversial cardiology consultant who seems to be Djokovic’s biggest fan and whose tweets are passionately quoted and forwarded by anti-vaxxers.

With tweets such as “Mark my words, with everything we know and don’t know about the current vaccine Novak Djokovic will ultimately be proven to be on the right side of history #BadPharma #truth #transparency #InformedConsent”:

And a retweet: “Dr Jordan Peterson Oh well. It’s just fertility. Women’s Periods May Be Late After Coronavirus Vaccination, Study Suggests”; he stirs the cooking pot of anti-establishment rhetoric and only deepens an already fractured relationship between doctors and their patients caused by the pandemic.

You’d think a mature, well-researched doctor would be able to tell the difference between the menstrual cycle and becoming fertile. You’d also hope he would not be short-sighted enough to support one of the most anti-science/anti-conventional medicine public figures in the world (see here)… Alas, no.

I feel as though both of these figures need to be reminded of their ethical duty of candour as doctors and reminded that their public actions have consequences. I may not completely disagree with Dr James (RE mandatory vaccinations) but the way in which he conducted himself during this nationally broadcasted video left many shaking with rage as it undermines many of his health professional colleagues. Me, included.

When a doctor appears on national news, opposing [mandatory] vaccination and offering incorrect explanations of why this is so, it should be obvious to them that their opinion will inevitably act as anti-vaccine propaganda, whether meant for this or not.

Malhotra’s ideas (cutting back on statins, healthy diet etc.) are often worth consideration/evaluation and as a new-age medical ‘influencer’ with 130k+ followers on Twitter, with ample publications behind him, he deserves to be listened to. Not necessarily agreed with, but listened to. But he also has a duty as a doctor to guard against complacency. Similar to James’ public actions, Malhotra’s tweets that are so one-sided give a biased, inaccurate and frankly dangerous view on the efficacy and safety profile of COVID vaccinations that have been safely and effectively used in millions of people to prevent hospitalisations. Is he doing it for the views? The hits? The likes? The retweets? To have people recognise him for his Pioppi diet?

What should we do?

Candour

Doctors, including James and Malhotra have an ethical responsibility not to spread imperfect information to a wide-receiving audience where their actions can be misconstrued and misrepresented so easily. Doing so may bolster anti-vaccine views, cause less ‘on-the-fence’ people to get the jabs and essentially lead to more preventable deaths.

More and more we are seeing social media take over and often act as the public’s primary source of news. More doctors than ever are now in the [social] media limelight. Some, such as Dr Alex George (mental health advocate) are promoting health responsibly. Others, seek to undermine it. In an era when Joe Rogan has more daily views than Fox News’ Tucker Carlson, to ignore and not rebut [health] social media giants like Malhotra would just worsen the situation. Malhotra and James need to be challenged by the scientific community, as the BBC so brilliantly did here.

Complacency

If doctors want to become socialite Instagram influencers, they must do this without complacency. I think this means being responsible when offering controversial and potentially public health implicating opinions where evidence isn’t clear cut.

Final thoughts

Using all the possible information above, as the vaccines are not 100% without risk, transmission is not completely cut post-vaccine and as we have a decent-ish way of monitoring infection (lateral flows and PCRs), I feel as though mandating vaccines for all NHS staff is currently unjust. I see Steve’s point. But I’d be extremely careful in how I’d make this point. And certainly not on live Sky News when the nation is watching, where it will inevitably be seized upon by the anti-vax community.

Saying this, the data is pretty clear that there is evidence that the vaccines offer protection against infection, reducing viral load quicker once infected and against hospitalisation and so if you’re a rational doctor who thinks that at least one time your lateral flow test may give a false negative, it makes complete sense to get your vaccine to protect your patients…

References

  1. https://www.bmj.com/content/376/bmj.o5?fbclid=IwAR2MgoD_vYo0FsaVsQdLxfeYCukuRu2RegcJa-HclA13byhH71g-AnNhnP8
  2. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1045329/Vaccine_surveillance_report_week_1_2022.pdf
  3. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1032859/Vaccine_surveillance_report_-_week_45.pdf
  4. https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(21)00690-3/fulltext

 

On this blog and elsewhere, I have heard many strange arguments against COVID-19 vaccinations. I get the impression that most proponents of so-called alternative medicine (SCAM) hold or sympathize with such notions. Here is a list of those arguments that have come up most frequently together with my (very short) comments:

COVID is not dangerous

It’s just a flu and nothing to be really afraid of, they say. Therefore, no good reason exists for getting vaccinated. This, I think, is easily countered by pointing out that to date about 5.5 million people have died of COVID-19. In addition, I fear that the issues of ‘long-COVID’ is omitted in such discussions

It’s only the oldies who die

As an oldie myself, I find this argument quite distasteful. More importantly, it is simply not correct.

Vaccines don’t work

True they do not protect us 100% from the infection. But they very dramatically reduce the likelihood of severe illness or death from COVID-19.

Vaccines are unsafe

We have now administered almost 10 billion vaccinations worldwide. Thus we know a lot about the risks. In absolute terms, there is a vast amount of cases, and it would be very odd otherwise; just think of the rate of nocebo effects that must be expected. However, the risks are mostly minor, and serious ones are very rare. Some anti-vaxxers predicted that, by last September, the vaccinated population would be dead. This did not happen, did it? The fact is that the benefits of these vaccinations hugely outweigh the risks.

Vaccines are a vicious tracking system

Some claim that ‘they‘ use vaccines to be able to trace the vaccinated people. Who are ‘they‘, and why would anyone want to trace me when my credit card, mobile phone, etc. already could do that?

Vaccines are used for population control

They‘ want to reduce the world population through deadly vaccines to ~5 billion, some anti-vaxxers say. Again, who are ‘they‘ and would ‘they‘ want to do that? Presumably ‘they‘ need us to pay taxes and buy their goods and services.

There has not been enough research

If those who make this argument would bother to go on Medline and look for COVID-related research, they might see how ill-informed this argument is. Since 2021, more than 200 000 papers on the subject have emerged.

I trust my immune system

This is just daft. I am triple-vaccinated and also hope that I can trust my immune system – this is why I got vaccinated in the first place. Vaccinations rely on the immune system to work.

It’s all about making money

Yes, the pharma industry aims to make money; this is a sad reality. But does that really mean that their products are useless? I don’t see the logic here.

People should have the choice

I am all for it! But if someone’s poor choice endangers my life, I do object. For instance, I expect other people not to smoke in public places, stop at red traffic lights and drive on the correct side of the street.

Most COVID patients in hospitals have been vaccinated

If a large percentage of the population has been vaccinated and the vaccine conveys not 100% protection, it would be most surprising, if it were otherwise.

I have a friend who…

All sorts of anecdotes are in circulation. The thing to remember here is that the plural of anecdote is anecdotes and not evidence.

SCAM works just as well

Of course, that argument had to be expected from SCAM proponents. The best response here is this: SHOW ME THE EVIDENCE! In response SCAM fans have so far only been able to produce ‘studies’ that are unconvincing or outright laughable.

In conclusion, the arguments put forward by anti-vaxxers or vaccination-hesitant people are rubbish. It is time they inform themselves better and consider information that originates from outside their bubble. It is time they realize that their attitude is endangering others.

 

THE GUARDIAN published an interesting article about vaccination hesitancy yesterday. Here is a short passage from it:

One major missing piece of the puzzle, currently under consideration, is a strategy that gets to the bottom of why 5 million people remained unvaccinated, especially those in communities with an ingrained distrust of authority.

No 10 even turned to an artificial intelligence (AI) company earlier in the year to determine the causes of vaccine hesitancy, but Whitehall sources acknowledge there is still a lack of understanding about how many of the unvaccinated remain so because of entrenched anti-vax ideology, misconceptions that could be turned around, a lack of time or transport to get to vaccine centres, or just apathy.

Yesterday, it was also reported in DER STANDARD that the Austrian Science Minister Martin Polaschek has commissioned a study from Statistics Austria, which for the first time was to look at the vaccination status of the population according to socio-economic characteristics.

The study yielded fascinating findings that might shed some light on the phenomenon of ‘entrenched anti-vax ideology’:

  • Across all age groups, the proportion of vaccinated persons, including recovered persons, is 67%.
  • Slightly less than four percent of the population are only recovered, and about 30% are neither one nor the other.
  • There are no marked differences between men and women.
  • The willingness to vaccinate is strongly related to the level of education.
  • The vaccination rate in the group of 25-64 year-olds with a university degree is about 84% and thus significantly higher than among those who have only basic education (68%).
  • In this age group, it also seems important whether someone has a job (76%) or not (69%).
  • People employed in the information and communication sector (85%) and public administration (83%) are the most likely to be vaccinated.
  • Workers in agriculture and forestry (67%) and construction (65%) are the least likely to accept vaccinations.
  • Health and social services personnel have a vaccination rate of 79%.
  • More than half of the 600,000 schoolchildren had already been vaccinated, and in the upper secondary school it was even 72%.
  • The rate among teachers is also high, at 85%.
  • 86% of the approximately 395,000 students at universities had been vaccinated.
  • As 92% of all medical students were vaccinated.
  • The vaccination rate among Austrian nationals, at about 70%, is clearly higher than that of people without an Austrian passport (52%).
  • The difference between those born in Austria and those not born in Austria is only five percentage points.
  • The willingness to be vaccinated is higher among people from Turkey (73%) than among those born in Austria (68%).
  • Among Germans and Afghans, it is around 72%.
  • People from Romania (43%) and the Russian Federation (45%) have the lowest vaccination rates.
  • The percentage of vaccinated people is highest among those between 75 and 84 years.

Similar findings have, of course, been reported from other countries. However, what seems new to me here is the finding that vaccination rates are strongly correlated to the level of education: the anti-vax brigade tends to be uneducated and ignorant. If confirmed, this suggests that education might be a way to make them accept vaccinations.

PS

Of course, correlation is not causality. But there seems to be a dose-response relationship between education and willingness to vaccinate. This makes a causal effect more likely.

 

Image

THOSE WHO KNOW NOTHING MUST BELIEVE EVERYTHING

 

 

Don’t worry -it happens to the best of us: you have forgotten to get a present for someone.

Do not panic!

Here are five items that we discussed in 2021 on this blog and which might be suitable as a last-minute festive present:

How about a neckless? I know, it is perhaps not everyone’s taste but it has the additional advantage that, contrary to the manufacturer’s claim that it protects you from disease-causing radiation, it actually emits (radioactive) radiation. Ideal for a radiant Christmas, would you not agree?

 

The festive season is foremost the season for love. If you want to make sure that your partner is tuned in, you must quickly get the LOVETUNER. Yes, it does work, after all, Deepak Chopra recommends it!

Another recommendation comes from the renowned Prof Harald Walach: a rosary! It is hard to imagine a present that befits Christmas better than this one.

Many people will over-indulge during the festive season. For them, Prince Charles’ Detox Tincture is the perfect present. You might have to search hard for it though; if I am correctly informed he had to take it off the market.

My final recommendation is divine – yes, truly! This divine protection oil is a must-have, particularly if you are not fully vaccinated.

PLEASE STAY HEALTHY OVER THE FESTIVE SEASON AND DON’T OVERDO IT,

WHATEVER YOU ARE UP TO.

Lian gong (LG), also called Lian Gong Shi Ba Fa, is a form of so-called alternative medicine (SCAM) from China.  More specifically, it is a set of stretching, breathing exercises, and self-massaging techniques aimed at preventing and relieving stress as well as acute pains around the neck, shoulders, back, hips, legs, joints, and connective tissues.  Even though it is relatively new, it is based on old Chinese stretching, breathing, and warm-up exercises dating back more than 1,000 years, including the Eight Silk Brocade (八段錦).  Lian gong has spread rapidly from China to other countries, especially to Japan and Brazil.

Lian Gong was developed by Dr. Zhuang Yuan Ming (1919- ), a traditional Chinese medical doctor, who started conducting a series of clinical trials around 1974 in a Shanghai hospital on patients suffering from a variety of stress-related conditions. Lian Gong is now being promoted as “massage in motion”.

One of the few controlled clinical studies of Liam gong aimed to evaluate the effects of LG on the impact of dizziness on the quality of life and fear of falling in primary health care patients. It was designed as a randomized clinical trial with 36 patients with dizziness not caused by central changes. The participants were randomly assigned to 3 groups:

  • the Liam gong (LG) group ( n = 11),
  • the vestibular rehabilitation (VR) group ( n = 11),
  • the control group ( n = 14).

The treatments were carried out over a period of 12 weeks.

Lian gong reduced the influence of dizziness on the quality of life in physical (1.8 points, 95% confidence interval [CI]: 0.2-3.4), functional (4.0 points, 95% CI: 2.1-5.9), and emotional domains of quality of life (4.4 points, 95% CI: 1.7-7.2), with no differences, compared with VR.

The authors concluded that Lian gong was shown to be an effective balance rehabilitation strategy to reduce the impact of dizziness on quality of life, with similar results to those of VR.

Unfortunately, this study has many flaws – not least its minute sample size. Therefore, the conclusions seem more than a little over-optimistic. I would not be all that surprised to learn that these exercises can have beneficial effects for a range of conditions. What seems doubtful in my view, however, is whether it is superior to more conventional exercise therapies.

This review investigated whether mind-body therapies are effective for relieving cancer-related pain in adults, since at least one-third of adults with cancer are affected by moderate or severe pain.

The authors searched for all randomized or quasi-randomized controlled trials that included adults (≥18 years) with cancer-related pain who were treated with:

  • mindfulness,
  • hypnosis,
  • yoga,
  • guided imagery,
  • progressive muscle relaxation.

The primary outcome was pain intensity.

A total of 40 primary studies involving 3569 participants were found. The meta-analysis included 24 studies (2404 participants) and showed a significant effect of -0.39 (95% CI -0.62 to -0.16) with considerable heterogeneity (I2 = 86.3%, p < 0.001). After excluding four “outlier” studies in sensitivity analyses, the effect size remained significant but became weaker. There was a high risk of bias in all studies, for example, performance bias due to lack of participant blinding. Patients in multiple settings were included but many studies were of low quality.

The authors concluded that mind-body therapies may be effective in improving cancer pain, but the quality of the evidence is low. There is a need for further high-quality clinical trials.

These conclusions are broadly correct. I can confirm this because I recently summarized the evidence in a book and arrived at very similar conclusions. If I had to criticize the review, it would be for not including all mind-body therapies for which there is evidence from clinical trials. In my book, I was able to include the following additional treatments:

  • Autogenic training
  • Music therapy
  • Qigong
  • Tai chi

The effects of these treatments are about the same regardless of which one we use. This might lead us to suspect that they work not via specific but via non-specific effects, e.g. placebo.

Yesterday, it was announced that the new German health secretary will be Dr. Karl Lauterbach. This seems a most reasonable choice (when did the UK last have a physician in that post?), and I certainly wish him the best of luck in his new position.

Lauterbach studied medicine at the RWTH Aachen University, University of Texas at San Antonio and University of Düsseldorf, where he graduated. From 1989 to 1992, he studied health policy and management as well as epidemiology at the Harvard School of Public Health in Boston, graduating with a Doctor of Science in 1992. From 1992 to 1993, he held a fellowship at the Harvard Medical School.

From 1998 until 2005, Lauterbach served as the director of the Institute of Health Economics and Clinical Epidemiology (IGKE) at the University of Cologne. He was appointed adjunct professor at the Harvard School of Public Health in 2008. He was a member of the Sachverständigenrat zur Begutachtung der Entwicklung im Gesundheitswesen (the council of experts advising the federal government on developments in the German healthcare system) from 1999 until he was elected to the Bundestag in September 2005.

But why does his appointment put the German defenders of homeopathy in a panic? The reason is simple: Lauterbach has in the past repeatedly argued against the reimbursement of homeopathy in Germany. This is, for instance, what DER SPIEGEL wrote in 2019 (my translation):

SPD parliamentary group vice-chairman Karl Lauterbach wants to prohibit public health insurance companies from reimbursing the costs of homeopathy. “We have to talk about this in the coalition,” he told the “Tagesspiegel”. Health insurance companies in Germany are not obliged to cover the costs of homeopathic treatments. However, they can pay for it voluntarily.

Voluntary benefits by health insurers must also be economically and medically reasonable, Lauterbach argues, referring to a similar push in France. According to the French Supreme Health Authority (HAS), the funds do not have sufficient scientific effect. The Ministry of Health had previously commissioned the HAS with the examination. It is considered likely that the French government will soon abolish the coverage of costs.

“In the spirit of reason and education as well as patient protection, it is also wrong in Germany for insurance companies to pay for homeopathy for marketing reasons,” Lauterbach wrote on Twitter in reaction to the decision in France. His demand is not new. Lauterbach had already spoken out in 2010 for a ban on the assumption of costs.

Many observers expect that Lauterbach – after getting the pandemic under control (not an easy task by any measure) – will indeed stop the reimbursement of homeopathy. Germany’s largest homeopathy producer reacted swiftly and is currently running an expensive campaign with full-page advertisements in German newspapers trying to improve the much-damaged public image of homeopathy:

In the advertisement above, for instance, it is implied that homeopaths are all in favor of vaccination. Regular readers of my blog will know that this is not true…

… and so does Dr. Lauterbach!

In 2013, Zuckerman et al. conducted a meta-analysis of 63 studies that showed a negative intelligence-religiosity relation (IRR). Now a new meta-analysis with an updated data set of 83 studies has re-addressed the issue.

The new analysis showed that the correlation between intelligence and religious beliefs in college and non-college samples ranged from -.20 to -.23. There was no support for mediation of the IRR by education but there was support for partial mediation by analytic cognitive style.

In 2012, Canadian scientists tested the hypothesis that an analytic cognitive style is associated with a history of questioning, altering, and rejecting (i.e., unbelieving) supernatural claims, both religious and paranormal. In two studies, they examined associations of God beliefs, religious engagement (attendance at religious services, praying, etc.), conventional religious beliefs (heaven, miracles, etc.), and paranormal beliefs (extrasensory perception, levitation, etc.) with performance measures of cognitive ability and analytic cognitive style. An analytic cognitive style negatively predicted both religious and paranormal beliefs when controlling for cognitive ability as well as religious engagement, sex, age, political ideology, and education. Participants more willing to engage in analytic reasoning were less likely to endorse supernatural beliefs. Further, an association between analytic cognitive style and religious engagement was mediated by religious beliefs, suggesting that an analytic cognitive style negatively affects religious engagement via lower acceptance of conventional religious beliefs.

Some time ago, I reported about a study concluding that a higher religiousness/spirituality is associated with a more frequent use of supplements or additional therapies in individuals with endocrinopathies or metabolic diseases. As so-called alternative medicine (SCAM) has been shown to be associated with worse outcome, addressing religiousness/spirituality which stresses the responsibility of the person for his life might offer an additional resource and should be further studied.

On this blog, we have discussed many times, that advocacy of SCAM is associated with vaccination hesitancy; see, for instance here, here, and here)

Finally, the findings of a recent study suggest that beliefs in an engaged God were associated with greater mistrust in the COVID-19 vaccine. This association was amplified for Hispanic and lower-educated Americans. The authors argued that beliefs in an engaged God may promote distrust of science, reduce motivation to get vaccinated, and derive comfort and strength by placing control over one’s life in the hands of a loving, involved deity.

There are, of course, other factors involved in the complex relationships between intelligence, religiosity, SCAM, and vaccination hesitancy. Yet, it seems clear that such links do exist. I agree that it is well worth investigating them in more detail.

By guest blogger Ken Harvey

Loretta Marron was the catalyst. The ‘critical thinking’ bug hit her as a child, reinforced by a BSc in Physics. If something didn’t sound logical, she couldn’t let it go. She had to check. She killed many a party by disputing misinformation – with evidence.

TV advertisements for magnetic underlays got her going, then homeopathic remedies, followed by ‘natural’ cures for cancer. To investigate outlandish claims and submit complaints, she needed to consult with experts. These included Professors John Dwyer (Medicine and Immunology) and Alastair MacLennan (Obstetrics and Gynaecology). They were always willing to help.

They also had concerns about universities teaching pseudoscience, such as ‘subluxation theory’ in chiropractic and ‘meridians’ in Traditional Chinese Medicine.

In late 2011, Professor Dwyer proposed that Loretta join forces with Professors Alastair MacLennan, Marcello Costa (neuroscientist), and Rob Morrison (science communicator) to form a new organisation promoting scientific evidence in health care. Friends of Science in Medicine (FSM) was born. John Dwyer was the inaugural President and Loretta Marron Chief Executive Officer (CEO).

The aim was to emphasise the importance of basing Australian health care on scientifically sound research and established scientific knowledge published in peer-reviewed journals of accepted standing. Valuing scientific rigour is especially important in an age where unsubstantiated health claims are rampant and scientific consensus is ‘imbalanced’ by the views of extremists.

FSM’s focus is helping consumers and health professionals to make more informed choices about medical interventions, medicines, and medical devices. We do this by submitting complaints about unethical practice, analysing policy, making submissions, encouraging regulators to act, and being a credible source of expertise for the media and others. We also encourage tertiary institutions and medicine and health sciences students to critically appraise therapeutic products and services as part of the courses offered.

Currently, FSM has more than 1,200 leading scientists, clinicians, lawyers, and consumer advocates as supporters. We also work closely with organisations such as Australian Skeptics and Choice (Australian Consumers Association).

I took over as President from John Dwyer in 2019. Loretta remains FSM CEO. The founding members continue their involvement as consultants. Ten years on, it’s worth reflecting on what has been achieved and the ongoing challenges.

An appendix lists some of the areas in which FSM has been involved and the outcomes achieved (often with the help of others).

Unethical promotion of therapeutic goods and services remain an ongoing concern. The advertising of therapeutic goods is subject to provisions in the Therapeutic Goods Advertising Code, first promulgated in 1999. Until July 2018, complaints about alleged Code violations were heard by the Therapeutic Goods Advertising Complaints Resolution Panel (CRP), thereafter by the Therapeutic Goods Administration (TGA).

FSM members submitted numerous complaints to the CRP and analysed the outcome. If a complaint was upheld, the CRP could only ‘recommend’ that it be removed. If it was not, the complaint was referred to the TGA for action. We found that certain companies consistently ignored the determinations of the CRP and, when referred to the TGA, took resulting action.

In July 2018, FSM engagement with numerous consultations and reviews eventually resulted in the TGA taking over the advertising complaint system. The TGA was given stronger investigative and compliance powers and a revised, legally enforceable advertising code. However, given the TGA’s previous track record, we continued to submit complaints, including many previously upheld by the CRP, but for which promotion continued.

An analysis of the first 12 months of the new system found that the TGA had classified most complaints as ‘low priority’. These were either ignored or closed by sending the advertiser a ‘Regulatory Obligation letter’ which stated that no further action would be taken. While the letter sometimes worked, often it did not. Stronger compliance powers were rarely used. The new complaint system was also less transparent than the one it replaced. For those low priority complaints with published outcomes, no details of the product, advertiser, or alleged Code violation were published, and no follow-up was recorded. Of 121 higher priority complaints, 79% failed to meet their key performance indicator, time to closure in 60–90 days. These included complaints about dangerous sports supplements and ineffective weight loss and hangover products.

In August 2020, an independent review of the first two years of the TGA’s compliant system was published. The study noted an unexpectedly high volume of complaints since the TGA took over the advertising complaints system, producing a large and growing backlog. A government-appointed consultant (ThinkPlace Pty Ltd) stated that providing more resources would not be in the public interest. Instead, they recommended a more cost-effective and efficient approach: amalgamating all complaints into an information database from which the TGA could consider compliance priorities.

As a result, complaints were closed by sending complainants a letter stating that their complaints will be used for ‘intelligence’ to set priorities. The TGA said risk assessment informed whether a complaint was converted into a case for investigation or stored in their information database to determine future compliance priorities. Therapeutic goods associated with COVID-19 were declared ‘priority 1’, while weight loss, hangover, and four other products groups were said to be ‘priority 2’.

A focus on COVID-19 stimulated the TGA to deal with some of these complaints more effectively. However, apart from token action on individual products, no systemic action was taken on weight loss, hangover products and many other objects of our complaints.

More recently, the TGA’s complaint database for 2018 -2020 has been removed and replaced by a new database containing only a few complaints pre-2021. In addition, the fields of many ‘products’ and ‘responsible person’, are missing. The TGA say that migration of data to the new system is continuing. Meanwhile, complainants now only receive an automated acknowledgment.

Transparency remains a problem as there is no clear indication of how many complaints the TGA receives, what they are about, how many are filed for ‘intelligence’’, how many are actioned, and what outcome eventuates.

Given this lamentable state of affairs, in association with Australian Skeptics, it is proposed to publish reports on all complaints submitted to the TGA in 2022 and their outcomes. Past experience shows that documenting problems, pointing out underlying issues and putting forward solutions can produce progress. But patience and persistence are required.

FSM has grappled with unethical advertising of pseudo-medical interventions. Controls differ for practitioners regulated by the Australian Health Practitioner Regulation Agency (AHPRA) and those regulated by State and Territory Health Complaints Commissioners. The former includes medical practitioners, pharmacists, nurses, chiropractors, osteopaths, and Traditional Chinese Medicine practitioners. The latter includes naturopaths, homeopaths, and practitioners of western herbal medicine.

FSM has held regular meetings with AHPRA senior managers. We have also met several of their national boards and attended stakeholder forums. Chiropractic was an initial focus. Many practitioners advertised that chiropractic care in pregnancy could shorten labour duration and prevent caesarean delivery – despite the absence of evidence. Pregnant women were warned that labour often resulted in the newborn babe’s spinal misalignment, which could lead to numerous problems unless put right by regular chiropractic adjustments. It was also claimed that chiropractic ‘adjustments’ could improve attention deficit hyperactivity disorder, infantile colic, and ear infection.

In 2015, FSM submitted hundreds of complaints to AHPRA, alleging that chiropractic websites were in breach of both s.133 of the Health Practitioner Regulation National Law Act 2009 and the Chiropractic Board of Australia’s Guidelines for advertising regulated health services. These provisions prohibit advertising which is false, misleading, or deceptive, creates an unreasonable expectation of beneficial treatment, or can encourage the indiscriminate or unnecessary use of health services.

Five years have passed since the Chiropractic Board first asked practitioners to ensure that their websites met legal advertising requirements. Over this time, the Board’s sole approach to this problem was educational. Although chiropractors consistently had the highest advertising complaints of all practitioners (38 per 1,000 chiropractors in 2013–14), no penalties nor disciplinary action had been applied for advertising offences.

FSM argued that repeated advertising offences required appropriate penalties. We also pointed out that some practitioners now invited patients to consult them about services they were no longer permitted to advertise. We said that limitations should be placed on chiropractic practice which lacked evidence.

AHPRA responded that, although it could act on misleading advertising, it had no power to restrict the scope of practice of chiropractors (or other registered practitioners). We said that, if lack of good evidence makes it illegal to publicly advertise a treatment, then it should be equally illegal to offer it to patients privately; after all, the real harm is caused by the treatment, not the advertising.

In 2019, following damning publicity and further representations, the Victorian Health Minister eventually instructed Safer Care Victoria (SCV) to undertake an independent review of the practice of chiropractic spinal manipulation on children under 12 years. The result was a recommendation that spinal manipulation should not be provided to children under 12 years of age, for general wellness or for the management of conditions such as hyperactivity disorders, infantile colic, or ear infections.

The Chiropractic Board has also stated that chiropractors are not trained to apply any direct treatment to an unborn child and should not deliver any treatment to the unborn child. Neither should they provide materials, information or advice that is anti-vaccination in nature. After numerous complaints from FSM members, the Chiropractic Board finally referred a prominent anti-vax chiropractor, Simon Floreani, to the Victorian Civil and Administrative Tribunal (VCAT). His registration was suspended for 6 months, and conditions placed on his re-registration.

FSM has not just been concerned about chiropractors. We have complained (with varied success) about medical practitioners promoting stem cell therapy for multiple sclerosis, Traditional Chinese Medical practitioners claiming that acupuncture can treat infertility and dubious laboratory tests used in complementary and alternative medicine.

In conclusion, the peddling of unproven and sometimes dangerous remedies has existed throughout human history.

There will always be companies (and individuals) who put the pursuit of profit before ethical behaviour. There will always be advocates for de-regulation and regulators captured by industry. To protect consumers there must be opposing forces. That is the role that FSM is proud to play, along with colleagues from the sceptical community and consumer movements.

Appendix

FSM activities and outcomes (often in association with others), 2011-2021.

  1. Removal of extravagant claims for acupuncture from the World Health Organization website and instigation of a WHO evidence review.
  2. Involvement in the 2015 Review of the Australian Government Rebate on Private Health Insurance for Natural Therapies. This led to removal of cover for therapies that lacked evidence such as homeopathy, iridology, reflexology and naturopathy (currently being reviewed again to see if additional evidence exits).
  3. Removal of unproven/disproven courses or modules from Australian universities.
  4. Removal of continuing professional development (CPD) points required annually by relevant registered practitioners for a number of AltMed courses.
  5. Following complaints to the TGA, removal of some illegal medicines not on the Australian Register of Therapeutic Goods (ARTG).
  6. De-listing some complementary medicines and medical devices (such as ‘bio-resonance’ machines) lacking evidence.
  7. Getting the TGA to declare two products of self-declared ‘Foods for special medical purposes’ illegal therapeutic goods and have them removed from the market-place.
  8. Publishing academic articles, in peer-reviewed journals, documenting regulatory problems investigated and solutions suggested.
  9. Publishing articles in lay media on current problems including in The Conversation, MJA Insight and Pearls and Irritations (around 200 over the last 5 years).
  10. Responding to consultation requests from the TGA, Medical Boards, National Medicines Policy Review, and others.
  11. Achieving the suspension of anti-vax chiropractor Simon Floreani’s registration.
  12. Stimulating the Chiropractic Board to publish standards on pregnancy and paediatric care.
  13. Responsible for the setting up of AHPRA’s ‘Advertising Compliance’ section, including their pilot auditing system (yet to report).
  14. Responding to requests for information from journalists.
  15. Correction of misinformation from the Victorian government’s ‘Better Health’ Channel.
  16. Providing a complaints avenue for people who want to remain anonymous.
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