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

regulation

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Cannabis seems often to be an emotional subject where more heat than light is generated. Does it work for chronic pain? This cannot be such a difficult question to answer definitively. Yet, systematic reviews have provided conflicting results due, in part, to limitations of analytical approaches and interpretation of findings.

A new systematic review is therefore both necessary and welcome. It aimed at determining the benefits and harms of medical cannabis and cannabinoids for chronic pain. Included were all randomised clinical trials of medical cannabis or cannabinoids versus any non-cannabis control for chronic pain at ≥1-month follow-up.

A total of 32 trials with 5174 adult patients were included, 29 of which compared medical cannabis or cannabinoids with placebo. Medical cannabis was administered orally (n=30) or topically (n=2). Clinical populations included chronic non-cancer pain (n=28) and cancer-related pain (n=4). Length of follow-up ranged from 1 to 5.5 months.

Compared with placebo, non-inhaled medical cannabis probably results in a small increase in the proportion of patients experiencing at least the minimally important difference (MID) of 1 cm (on a 10 cm visual analogue scale (VAS)) in pain relief (modelled risk difference (RD) of 10% (95% confidence interval 5% to 15%), based on a weighted mean difference (WMD) of −0.50 cm (95% CI −0.75 to −0.25 cm, moderate certainty)). Medical cannabis taken orally results in a very small improvement in physical functioning (4% modelled RD (0.1% to 8%) for achieving at least the MID of 10 points on the 100-point SF-36 physical functioning scale, WMD of 1.67 points (0.03 to 3.31, high certainty)), and a small improvement in sleep quality (6% modelled RD (2% to 9%) for achieving at least the MID of 1 cm on a 10 cm VAS, WMD of −0.35 cm (−0.55 to −0.14 cm, high certainty)). Medical cannabis taken orally does not improve emotional, role, or social functioning (high certainty). Moderate certainty evidence shows that medical cannabis taken orally probably results in a small increased risk of transient cognitive impairment (RD 2% (0.1% to 6%)), vomiting (RD 3% (0.4% to 6%)), drowsiness (RD 5% (2% to 8%)), impaired attention (RD 3% (1% to 8%)), and nausea (RD 5% (2% to 8%)), but not diarrhoea; while high certainty evidence shows greater increased risk of dizziness (RD 9% (5% to 14%)) for trials with <3 months follow-up versus RD 28% (18% to 43%) for trials with ≥3 months follow-up; interaction test P=0.003; moderate credibility of subgroup effect).

The authors concluded that moderate to high certainty evidence shows that non-inhaled medical cannabis or cannabinoids results in a small to very small improvement in pain relief, physical functioning, and sleep quality among patients with chronic pain, along with several transient adverse side effects, compared with placebo.

This is a high-quality review. Its findings will disappoint the many advocates of cannabis as a therapy for chronic pain management. The bottom line, I think, seems to be that cannabis works but the effect is not very powerful, while we have treatments for managing chronic pain that are both more effective and arguably less risky. So, its place in clinical routine is debatable.

PS

Cannabis is, of course, a herbal remedy and therefore belongs to so-called alternative medicine (SCAM). Yet, I am aware that the medical cannabis preparations used in most studies are based on single cannabinoids which makes them conventional medicines.

The General Chiropractic Council (GCC) regulates chiropractors in the UK, Isle of Man, and Gibraltar to ensure the safety of patients undergoing chiropractic treatment. The GCC sets the standards of chiropractic practice and professional conduct that all chiropractors must meet.

By providing a lengthy ruling in the case of the late John Lawler and his chiropractor, Arlene Scholten, the GCC has recently established new standards for chiropractors working in the UK, Isle of Man, and Gibraltar (see also today’s article in The Daily Mail). If I interpret the GCC’s ruling correctly, a UK chiropractor is henceforth allowed to do all of the following things without fearing to get reprimanded, as long as he or she produces evidence that the deeds were done not with malicious intentions but in a state of confusion and panic:

  • Treat a patient with treatments that are contraindicated.
  • Fail to obtain informed consent.
  • Pose as a real doctor without informing the patient that the practitioner is just a chiropractor who has never been near a medical school.
  • Cause the death of a patient by treatment to the neck.
  • Administer first aid in a way that makes matters worse.
  • Tell lies to the ambulance men who consequently failed to employ a method of transport that would save the patient’s life.
  • Keep inaccurate patient records that conceal what treatments were administered.

In previous years, the job of a chiropractor had turned out to be demanding, difficult, and stressful. This was due not least to the GCC’s professional standards which UK chiropractors were obliged to observe. The code of the GCC stated prominently that “our overall purpose is to protect the public.

All this is now a thing of the past.

The new ruling changed everything. Now, UK chiropractors can relax and can happily pursue their true devotion, namely to keep their bank manager happy, while not worrying too much about the welfare and health of their patients.

In the name of all UK chiropractors, I herewith express my thanks to the GCC for unashamedly protecting first and foremost the interests of their members, while tacitly discarding medical ethics and evidently not protecting the public.

MAKE CHIROPRACTIC GREAT AGAIN!

This retrospective electronic medical record data analysis compared the characteristics and outcomes of drug-induced liver injury (DILI) caused by paracetamol and non-paracetamol medications, particularly herbal and dietary supplements. Adults admitted with DILI to the Gastroenterology and Liver Centre at the Royal Prince Alfred Hospital, Sydney (a quaternary referral liver transplantation centre), 2009-2020 were included. The 90-day transplant-free survival and the drugs implicated as causal agents in DILI were extracted from the records.

A total of 115 patients with paracetamol-related DILI and 69 with non-paracetamol DILI were admitted to our centre. The most frequently implicated non-paracetamol medications were:

  • antibiotics (19, 28%),
  • herbal and dietary supplements (15, 22%),
  • anti-tuberculosis medications (6, 9%),
  • anti-cancer medications (5, 7%).

The number of non-paracetamol DILI admissions was similar across the study period, but the proportion linked with herbal and dietary supplements increased from 2 of 11 (15%) during 2009-11 to 10 of 19 (47%) during 2018-20 (linear trend: P = 0.011). Despite higher median baseline model for end-stage liver disease (MELD) scores, 90-day transplant-free survival for patients with paracetamol-related DILI was higher than for patients with non-paracetamol DILI (86%; 95% CI, 79-93% v 71%; 95% CI, 60-82%) and herbal and dietary supplement-related cases (59%; 95% CI, 34-85%). MELD score was an independent predictor of poorer 90-day transplant-free survival in both paracetamol-related (per point increase: adjusted hazard ratio [aHR], 1.19; 95% CI, 1.09-3.74) and non-paracetamol DILI (aHR, 1.24; 95% CI, 1.14-1.36).

The authors concluded that, in our single centre study, the proportion of cases of people hospitalised with DILI linked with herbal and dietary supplements has increased since 2009. Ninety-day transplant-free survival for patients with non-paracetamol DILI, especially those with supplement-related DILI, is poorer than for those with paracetamol-related DILI.

A co-author of the paper, specialist transplant hepatologist Dr Ken Liu, was quoted in the Guardian saying he felt compelled to conduct the study because he was noticing more patients with liver injuries from drugs not typically associated with liver harm. “I was starting to see injury in patients admitted with liver injury after using bodybuilding supplements for males or weight loss supplements in females,” he said. “I just decided I better do a study on it to see if my hunch that more of these substances were causing these injuries was true.”

Liu and his colleagues said there needed to be more rigorous regulatory oversight for supplements and other alternative and natural therapies. They also noticed almost half the patients with supplement-induced severe liver injury had non-European ethnic backgrounds. Liu said more culturally appropriate community education about the risks of supplements was needed.

Dr Ken Harvey, public health physician and president of Friends of Science in Medicine, said it was important to note that Liu’s study only examined the most severe cases of supplement-induced liver harm and that the actual rate of harm was likely much higher. “The study only examines severe cases admitted to a specialised liver unit; they cannot be extrapolated to the overall incidence of complementary medicine associated liver injury in Australia,” Harvey said.

The Royal Australian College of General Practitioners, Choice, Friends of Science in Medicine and others have called for an educational statement on the pack and promotional material of medicines making traditional claims, for example saying “This product is based on traditional beliefs and not modern scientific evidence”.

“This was opposed by industry and the TGA,” Harvey said. “But is still needed.”

Health Canada is a government agency responsible for helping Canadians maintain and improve their health. It ensures that high-quality health services are accessible, and works to reduce health risks. Health Canada regulates consumer health products that are sold directly to consumers and do not require a prescription or the oversight of a health care professional. In the past, Health Canada has approved more than 8,500 homeopathic products. A recent survey by Health Canada showed that 11% of parents and guardians believe that alternative practices such as homeopathy or naturopathy can replace vaccines.

Now, Health Canada is proposing changes to the labelling and evidence requirements for homeopathic products, as part of the proposed guidance document: Labelling Requirements for Natural Health Products. These changes would require that all homeopathic products that are sold over the counter include on the front panel of their label the statement “This claim is based on traditional homeopathic references and not modern scientific evidence.” Health Canada is also consulting on the introduction of risk-based evidence standards for homeopathic products, which would align requirements with those of other natural health products. The public consultation opens June 26, 2021 and closes September 4, 2021. For more information on how to participate, visit Consultation – Proposed Amendments to the Natural Health Products Regulations.

I hope you agree with me that it might be worth participating in this public consultation with a view of preventing regulations that could open the door to quackery in Canada. So, please do have a look at the documents and make sure that Canadian consumers are adequately protected.

The UK Society of Homeopaths (the organization of the UK non-medically trained homeopaths) has featured on this blog many times, e.g.:

Now, the Society has released the following statement:

The Society of Homeopaths (the Society) has taken part in the Accredited Registers Programme run by the Professional Standards Authority (the Authority) since 2014. This accreditation has provided additional assurance to our members and their patients of the professional standards that we have promoted and maintained for over 40 years.

Public protection, patient safety and patient choice are paramount and built into all the Society’s processes and governance. Accountability is ensured through a balance of representation by practitioners and independent members on the Board as well as on the Society’s professional standards and education committees.

Since July 2020 the Society and its members have put tremendous effort into addressing the concerns of the Authority and following the suspension of our accreditation in January 2021, we said we would take time to consider both the Authority’s report and our own position. This has since been superseded by the Authority’s review of its own accreditation scheme and fee structure in the light of the proposed withdrawal of its government funding.

After a number of consultations with the Authority, it has become clear to the Society that the new fee structure for the Accredited Registers Programme disadvantages smaller organisations in favour of larger bodies, and the fee increase proposed by the Authority to the Society, aside from lacking clarity for the future, effectively prices us out of the scheme. Further changes to the Authority’s standards and criteria are also still to be confirmed. The Board has therefore made the decision to withdraw from the Authority’s voluntary accreditation scheme.

We will continue to strengthen our 43-year tradition of being the most highly valued and professional organisation for homeopaths in the UK. The Society’s mission remains to ensure that patients receive the highest standards of care from our trusted members.

 

I wonder from which organization the Society of Homeopaths might now obtain an accreditation.

Is there an ‘Unprofessional Standards Authority’?

If not, might they create one?

Watch this space!

In 2020, a German court had ruled that pharmacies should be allowed to advertise homeopathic products by naming their alleged source materials, even if the dilution is so high that there is nothing in the products. An appeal against this was launched and it has now ended in defeat. The consequences for homeopathy could be far-reaching.

In homeopathy, it is customary to label and advertise products by naming the starting material or ‘mother tincture’. A German pharmacy thus named one of its products “HCG C30 globules” – HCG is a pregnancy hormone, C30 means it is diluted 30 times in the ratio 1:10o.  A group sued arguing that this was misleading.

The Darmstadt Regional Court first ruled that just because the original substance is no longer detectable does not mean that it is no longer present. And in any case, proponents of homeopathy would consider a high dilution to be important in order to reduce side effects. This ruling and the way it was justified caused considerable criticism. However, the plaintiff did not let up and appealed.

In the second instance, the Frankfurt Higher Regional Court (Case No. 6 U 49/20) took a completely different view of the matter. In the appeal hearing, it clarified first that advertisements for homeopathy address not only enthusiasts of homeopathy but the general public. Therefore, it must be in accordance with the general understanding of the population. And the public expects a product labeled “HCG” to actually contain the pregnancy hormone. If this ingredient cannot be detected, the product labeling would be misleading.

In essence, this means that all high potency homeopathic remedies (all beyond a C12) may no longer print the name of the mother tincture on the label. One can expect that this will seriously impact the sales of homeopathic products in Germany. This might re-open the discussion on the question of whether pharmacies should sell homeopathic preparations in the first place. As I have pointed out ad nauseam (e.g. here, here, and here), if pharmacists offer them to their customers pretending they are effective medicines, they violate their own ethical code. In other words, there is no place for homeopathy in pharmacies.

 

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.

A PROVOCATION is an action or speech that makes someone annoyed or angry, especially deliberately. In law, provocation is when a person is considered to have committed an act partly because of a preceding set of events that might cause a reasonable person to lose self-control.

An INSULT is an expression, statement, or behavior which is disrespectful or scornful. Insults may be intentional or accidental. An insult may be factual, but at the same time pejorative.

An AD HOMINEM ATTACK is an attack on the character of a person who tends to feel the necessity to defend himself or herself from the accusation.

Despite all my attempts to keep the exchanges on this blog reasonably polite, civil, and respectful, I seem to have been less than successful. This, of course, is not least my fault. I am as prone to lose my temper as anyone else, and I admit that, after decades of discussing with irrational people, my patience wears thin.

What should we do about it?

To start with, we need to understand what typically happens. In most cases, things start with a provocation. Let’s consider a recent example. As a response to my perfectly non-provocative post entitled A LOOK AT MY OWN PUBLICATIONS, I got this response:

“Surprisingly, not many of these papers are in the ‘top 100’. I am not sure whether this is meaningful and if so how I should interpret this.”

Perhaps your fame was overshadowed after Hahn showed that you manipulate data and now you are taken seriously into account only by foreign lobbies (such as the “Questao da Ciencia Institute”) and German lobby that you run from your country. It’s normal, Ernst, it’s not surprising that your colleague Natalia Pasternak pathetically cites your book in her article to justify the elimination of homeopathy in Brazil.

As we had discussed Robert Hahn’s misunderstanding of my research several times previously on this blog, my response was to simply post one of the posts that had dealt with the issue. The comment that followed was even more insulting than his previous one. My reaction was to ban the author.

This course of events is fairly typical. Normally, the sequence is as follows:

  1. I (or someone else) post something that displeases a reader.
  2. He responds with a provocation.
  3. I give him back accordingly.
  4. Things escalate until he posts one or more full-blown insults or ad hominem attacks.
  5. Eventually, I ban the author.

I wonder how these unpleasantries might be avoided.

  1. I could phrase my posts in a way that is less provocative to fans of so-called alternative medicine (SCAM). I have often considered doing this. So far, I have mostly decided against it, because I feel a certain amount of provocation is healthy and needed to stimulate discussions. If I changed my style, it would be at the cost of the interest this blog often attracts.
  2. I could refuse to give back in the same coinage as I receive. This is precisely what I very often try. Yet, sometimes I fail. Sorry!
  3. I could be much stricter and ban people at the first signs of misbehavior. This, I fear, would take much of the spice and excitement out of our discussions and reduce the entertainment value of my blog.
[The points above apply, of course, also for everyone else who comments on this blog]

There is no easy solution, as far as I can see.

For the time being, I will try harder to be polite and civil, and I do beg all of my readers to do the same. Other than this, there is not much that I will change. Oh, I almost forgot: there is also this previous post of mine which I usually send to people who, in my view, have overstepped the mark. It might serve as a caution that I am considering banning that person if things don’t improve.

Bottom line: thanks everyone for your efforts to control your aggressions!

 

As I have reported previously, homeopathy has recently had a hard time in Germany. The following short note appeared in the German Medical Journal. Allow me to translate it for you:

The Higher Administrative Court of Bremen has rejected as inadmissible the application for a judicial review by a Bremen physician against the deletion of the ‘HOMEOPATHY’-title from the further training regulations of the Bremen Medical Association (decision of June 2, 2021). Thus, the new regulation for postgraduate training of the Bremen Medical Association without the additional designation of homeopathy has been upheld.

“We are very pleased that the Court shares our legal opinion and has rejected the plaintiff’s application,” said Heike Delbanco, Chief Executive Officer of the Bremen Medical Association. “This is also a clear signal for other German medical associations where comparable lawsuits against the removal of homeopathy from the canon of additional designations are pending.”

The Assembly of Delegates of the Medical Association had decided in September 2019 on a new training regulation, which – unlike the previous regulation – no longer provided for the postgraduate training in homeopathy. After the expiry of a transitional period, the qualification of homeopathy can therefore no longer be acquired at the Bremen Medical Association; however, titles already acquired can continue to be held.

A physician from Bremen, who holds the title of homeopathy, brought an action before the Higher Administrative Court against the cancellation of the additional title. He claimed that the removal of the additional designation from the continuing education regulations interfered with his fundamental right to freedom of profession and his fundamental right to property and complained of a violation of the general principle of equality. The medical association considered the action inadmissible.

The Higher Administrative Court now rejected the application, since a violation of the plaintiff’s rights could not be recognized. The plaintiff can continue to use his title HOMEOPATHY also under the new regulations.

The expectations presented by him – in particular, the expectation to find suitable practice representatives and to be able to sell his practice on retirement at a profit – do not justify any legal positions protected by fundamental rights and consequently also no obligation of the Bremen Medical Association to enable physicians to obtain the additional title of homeopathy in future.

________________________

As several further medical associations in Germany have banned homeopathy in the same way as Bremen and were consequently also taken to court by homeopathy enthusiasts, one can be optimistic that these cases will also go against homeopathy.

By guest blogger Michael Scholz

For several years, the “flower essences” invented by Dr. Edward Bach had a difficult time in the European Union and especially Germany. The manufacturers were regularly taken to court for violating the EU Health Claim Regulation. This now culminates in the fact that the manufacturer, Nelsons, who sells the “Original Bach Flowers” in Germany, was forced to rename its popular “Rescue” remedies.

What happened?

The “Rescue” remedies were promoted with statements such as “calm and strong through the day” and “recommended use in emotionally exciting situations, e.g. at work” or to “face emotional challenges”. The competitor, Annoyax Nutripharm, regarded this as a health-related statement that is prohibited according to the EU Health Claim Regulation. Since the “Bach Flower Remedies” are not considered to be medicinal products in Germany, they are treated as food supplements, according to a ruling by the Oberlandesgericht (Higher Regional Court) Hamburg in 2007.

As it is strictly forbidden to advertise food supplements with health-related claims that are unproven, Annoyax Nutripharm filed a lawsuit against Nelsons that all the way to the Bundesgerichtshof (Federal High Court of Justice) in Karlsruhe. Since the case concerned European law, the judges in Karlsruhe referred it to the European Court of Justice in Luxemburg.

The judges wanted two questions clarified: 1. Are the “Rescue” remedies to be regarded simply as Brandy due to their alcohol content of 27%? (in which case, health-related claims would be strictly forbidden). 2. Does the product’s name “Rescue” itself constitute a violation of the Health Claims Regulation?

The Luxemburg judges ruled “No” and “Yes”. “No”, it is not Brandy, although the „essences“ consist of a considerable quantity of alcohol, the recommended dose is too small to be intoxicating. But “Yes”, the term “Rescue” does indeed violate the Health Claim Regulation. So the plaintiff won – and what is the result?

When the Health Claims Regulation was enacted in 2005, a transition period until 2022 was established. This applied to all products that were sold using the same brand name and composition before 2005. This now gave the defendant – Nelsons – the opportunity to use Edward Bach’s 135th anniversary for launching an advertising campaign that praises the court-ordered renaming as „modernization“ for the 21st century. And as you see, the new name is a paragon of creativity, innovation & modernism, indeed (//irony:off): “Rescue” becomes – drum roll – “Rescura”. Yes, I looked just like that too…

This pyrrhic victory for the plaintiffs shows how important it is to protect the European citizens against misleading advertising. And – far more important – it is now established through a ruling of the Federal High Court of Justice that “Bach Flowers” are an esoterical concept devoid of medical evidence.

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