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

informed consent

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Guest post by Ken McLeod

This week a Coroner’s Inquest into the death of Jarrad Antonovich resumes [1] in Byron Bay, New South Wales, Australia. Meanwhile, pending the outcome of Inquests and other investigations, the NSW Health Care Complaints Commission has imposed interim prohibition order on Mr Soulore Solaris, ‘….a Counsellor who facilitates Ayahuasca ceremonies.’

Under section 41AA of the Health Care Complaints Act 1993 (Act), Mr Solaris: “….must not under any circumstances provide, or cause to be provided, any health services, either in paid employment or voluntary, to any member of the public.” [2] This applies until 11 March 2024, when the matter will be reconsidered.

So what is all this about? To go back a while, Mr Antonovich died from a perforated oesophagus after consuming ayahuasca and kambo frog toxin in October 2021, at the age of 46, while attending the ‘Dreaming Arts festival’, a six-day retreat at Arcoora near Kyogle in northern New South Wales. At the festival he had consumed ayahuasca and participated in a “Kambo” ceremony, involving secretions harvested from an Amazonian tree frog.

Ayahuasca is a psychedelic substance made from boiling plants that is used in ritualistic ceremonies in the Amazon basin. [3] Ayahuasca contains chemicals of concern, such as N,N-Dimethyltryptamine (DMT), a highly psychedelic substance and a Schedule I drug under the Convention on Psychotropic Substances. Ayahuasca is illegal in many countries, and it is illegal to sell, import, produce and possess it in Australia. [4]

Kambo is made from secretions harvested from an Amazonian tree frog. Kambo is usually used in a group setting, called a Kambo circle or Kambo ceremony. Wikipedia lists a whole smorgasbord of dangerous consequences, including tachycardia, nausea, vomiting, diarrhea, psychosis, SIADH, kidney damage (including acute renal failure), pancreas damage, liver damage including toxic hepatitis, dermatomyositis, esophageal rupture, seizures, and death. [5]

The Australian Therapeutic Goods Administration has listed it as a schedule 10 poison, in the category for “substances of such danger to health as to warrant prohibition of sale, supply and use”. [6]

Earlier in the Inquest we heard that:

  • – While Jarrad Antonovich‘s condition worsened there was resistance to calling for an ambulance. An ambulance was finally called at 11.30pm and took an hour to arrive because of the remote location.
  • -One ambulance officer reported that a female told them to “move away from Jarrad because it was affecting his aura” and no one told them he had consumed Kambo. [7]
  • -The event organiser Soulore “Lore” Solaris described Jarrad Antonovich’s death as ‘beautiful.’ [8]
  • -Fred Woller, the site manager at Arcoora, was unaware those running the event did not have any medical training. [9]
  • -Soulore “Lore” Solaris said Mr Antonovich ”…. had good support, a couple of kinesiologists with him and they couldn’t find anything wrong,” [10]
  • -Mr Antonovich “was surrounded by people who loved him and an Aboriginal elder called Uncle Andrew who was chanting sacred songs and calling the spirit out of his body” and “the koalas were making a special sound that is known to the elders when the land accepts a spirit”.
  • -“Mr Solaris has stated that he has plans to leave Australia for Brazil to visit his teachers.” [11]

We will keep you informed.

REFERENCES

  • 1 Court Lists http://tinyurl.com/3fzjd6uy
  • 2 Health Care Complaints Commission http://tinyurl.com/yh76rzc6
  • 3 The Guardian http://tinyurl.com/328manjt
  • 4 Wikipedia https://en.wikipedia.org/wiki/Legal_status_of_ayahuasca_by_country
  • 5 Wikipedia https://en.wikipedia.org/wiki/Kambo_(drug)
  • 6 The Guardian http://tinyurl.com/2s398psy
  • 7 The Guardian http://tinyurl.com/328manjt
  • 8 ABC http://tinyurl.com/5n7ejydy
  • 9 The Guardian http://tinyurl.com/59wa3rmn
  • 10 ABC http://tinyurl.com/5n7ejydy
  • 11 Byron Bay Echo http://tinyurl.com/44n78s2w

The French ‘National Assembly’ has yesterday adopted a major law aimed at reinforcing the prevention and combat against sectarian aberrations in France. This marks a significant step forward in strengthening the protection of citizens against abuse and manipulation by charlatans, gurus and other sectarian movements.

This bill, the result of particularly fruitful work and debate in both chambers, reflects the Government’s commitment to meeting the expectations of the victims of these sectarian movements.

Some of the key measures voted through by parliamentarians include:

  • The enshrinement in law of the powers of MIVILUDES (Interministerial Mission of Vigilance and Combat against Sectarian Aberrations);
  • The reinforcement of the penal response with the creation of the offence of placing or maintaining in a state of psychological or physical subjection;
  • The creation of an offence of incitement to abandon or refrain from treatment, or to adopt practices which clearly expose the person concerned to a serious health risk;
  • Support for victims, with the extension of the categories of associations that can bring civil action;
  • Information for the judiciary, with the introduction of an “amicus curiae” role for certain government departments in legal cases relating to cults.

Despite sometimes heated debates, particularly around article 4, fuelled by the opinion of the Conseil d’Etat, the adoption of this law by the National Assembly bears witness to a shared desire to protect the rights and freedoms of individuals while providing better protection for our fellow citizens against sectarian aberrations.

This bill is part of a multi-annual national strategy for 2023-2027 resulting from the conference on sectarian aberrations held in spring 2023. It is a major step towards strengthening the penal arsenal and protecting victims.

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Sabrina Agresti-Roubache, Secretary of State for Citizenship and Urban Affairs, commented:

“Long-awaited by victim support associations, this text aims to strengthen our legal arsenal in the fight against sectarian aberrations. I’m delighted that all the articles have been adopted, particularly Article 4, which creates an offence of incitement to abandon or abstain from treatment. There have been some passionate debates in the Chamber, but I’d like to reiterate the basis of this bill: the State is not fighting against beliefs, opinions or religions, but against all forms of sectarian aberrations, these dangerous behaviors which represent a threat to our social cohesion and put lives at risk.”

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Obviously, we shall have to see how the new law will be applied. But, in any case, it is an important step into the right direction and could put an end to much of so-called alternative medicine that endangers the health of French consumers.

Other nations should consicer following the Franch example.

We have often asked whether the General Chiropractic Council (GCC) is fit for purpose. A recent case bought before the Professional Conduct Committee (PCC) of the GCC provides further food for thought.

The male chiropractor in question admitted to the PCC that:

  • he had requested the younger female patient remove her clothing to her underwear for the purposes of examination;
  • he then treated the area near her vagina and groin with a vibrating tool;
  • that he also treated the area around her breasts.

After the appointment, which the patient had originally booked for a problem with her neck, the patient reflected on the treatment and eventually complained about the chiropractor to the GCC. The PCC considered the case and did not find unprofessional conduct in the actions and conduct of the chiropractor. His the diagnosis and treatment were both found to be clinically justified.

According to the GCC, the lesson from this case is that the complaint to the GCC may have been avoided if the chiropractor had been more alert to the need to ensure he communicated effectively so that the patient was clear as to why the intimate areas were being treated and, on that basis, given informed consent. Patients often feel vulnerable before, during and after treatment; and this effect is magnified when the patient is unclothed, new to chiropractic treatment or the work of a particular chiropractor, or they are being treated in an intimate area. Chiropractors can reduce this feeling of vulnerability by offering a chaperone and gown (and recording a note of the patient’s response) as well as taking the time to ensure you have fully explained the procedure to them and obtained informed consentStandard D4 of the GCC Code states registrants must “Consider the need, during assessments and care, for another person to be present to act as a chaperone; particularly if the assessment or care might be considered intimate or where the patient is a child or a vulnerable adult.”

Excuse me?

I find this unbelievably gross and grossly unbelievable!

It begs, I think, the following questions:

  • What condition requires treatment with a ‘vibrating tool’ near the vagina (I assume they mean vulva)?
  • What condition requires treatment with a ‘vibrating tool’ around the breasts?
  • Is there any reliable evidence?
  • Was informed consent obtained?
  • What precisely did it entail?

About 15 years ago, I was an expert witness in a very similar UK case. The defendant was sent to prison for two years. The GCC is really not fit for purpose. It seems to consistently defend chiropractors rather than do its duty and defend their patients.

My advice to the above-mentioned patient is not to bother with the evidently useless GCC but to initiale criminal proceedings.

I have been banging on about informed consent many times; not because I have a bee in my bonnet, I hope, but because it is of vital importance. Here are a few examples:

I am convinced that informed consent is a key issue in so-called alternative medicine (SCAM). Thus I was delighted to find an article that fully agrees with my view. Even though it has been published a few years ago, it is, I feel, important enough to cite it here:

The demand for informed consent in clinical medicine is usually justified on the basis that it promotes patient autonomy. In this article I argue that the most effective way to promote autonomy is to improve patient understanding in order to reduce the epistemic disparity between patient and medical professional. Informed consent therefore derives its moral value from its capacity to reduce inequalities of power as they derive from epistemic inequalities. So in order for a patient to have given informed consent, she must understand the treatment. I take this to mean that she has sufficient knowledge of its causal mechanisms and has accepted the explanations in which the treatment is implicated. If this interpretation of informed consent is correct, it is unethical for medical professionals to offer or endorse ‘alternative medicine’ treatments, for which there is no known causal mechanism, for if they do, they may end up widening the epistemic disparity. In this way, informed consent may be understood as an effective way of ruling out particular treatments in order to improve patient autonomy and maintain trust in the medical profession.

In other words, if we apply one of the most fundamental rule of medical ethics to SCAM, it would bring about the end of most of SCAM. If we fail to do this, we accept that SCAM is unethical which, in my view, is not a reasonable option.

Patients are increasingly using and requesting so-called alternative medicine Medicine (SCAM), especially during the COVID-19 pandemic. However, it remains unclear whether they use SCAMs in conjunction with conventional medicine or to replace vaccination or other approaches and whether they discuss them with their physicians as part of shared decision-making. This study aimed to evaluate the use and initiation of SCAM during the COVID-19 pandemic, focusing on the association between SCAM-use and COVID-19 vaccination status.

It was a part of the longitudinal cohort of the CoviCare program, which follows all outpatients tested for COVID-19 at the Geneva University Hospitals. Outpatients tested for COVID-19 were contacted 12 months after their positive or negative test between April and December 2021. Participants were asked about their vaccination status and if they had used SCAM in the past 12 months. SCAM-use was defined based on a list of specific therapies from which participants could choose the options they had used. Logistic regression models adjusting for age, sex, education, profession, severe acute respiratory system coronavirus 2 (SARS-CoV-2) infection, and pre-existing conditions were used to evaluate the association between being unvaccinated and complementary medicine use. SARS-CoV-2 infection status was evaluated for effect modification in the association between being unvaccinated and complementary medicine use.

This study enrolled 12,246 individuals (participation proportion = 17.7%). Their mean age was 42.8 years, 59.4% were women, and 63.7% used SCAM. SCAM-use was higher in women, the middle-aged, and those with a higher education level, a SARS-CoV-2 infection, or pre-existing co-morbidities. A third of cases initiated SCAM as prevention against COVID-19. Being unvaccinated was associated with higher levels of SCAM-use (adjusted odds ratio [aOR] 1.22 [1.09–1.37]). SCAMs were frequently used for COVID-19 prevention (aOR 1.61 [1.22–2.12]). Being unvaccinated was associated with the use of several specific SCAMs:

  • zinc (OR 2.25 [1.98–2.55]),
  • vitamin D (OR 1.45 [1.30–1.62]),
  • vitamin C (OR 1.59 [1.42–1.78]).

Only 4% of participants discussed using SCAM with their primary care physicians.

The authors concluded that, while SCAM is increasingly used, it is rarely discussed with primary care physicians. SCAM-use, especially for COVID-19 prevention, is associated with COVID-19 vaccination status. Communication between physicians, patients, and SCAM therapists is encouraged to facilitate a truly holistic approach to making a shared decision based on the best available information.

This survey confirmed the findings of several previous investigations. It also shows that the terminologies often employed are inadequate:

  • alternative medicine: as it does not work, it cannot be an alternative;
  • complementary medicine: many patients do not use it to complement real medicine.

As I have explained many times, I thus find SCAM a much more appropriate term.

The last sentence of the authors conclusion is puzzeling. What can SCAM pratitioners contribute to a ‘truly holistic approach’ to decisions about vaccinations? I feel this sentence should be changed into something like the following:

Communication between physicians and patients should be encouraged.  To facilitate an effective approach to making shared decisions on vaccinations, SCAM practitioners should be excluded until they are able to convincingly demonstrate that their advice is based on sound evidence.

The NZZ recently published a long and horrific report about a natural health clinic and its doctors. Here is a  version translated and shortened by me; perhaps it makes a few people think twice before they waste their money and risk their health:

It is a narrow mountain road that they are racing down on this spring evening. Over the green Appenzell hills, towards Herisau hospital. Kathrin Pfister* is fighting for her life in the car. At the wheel is Thomas Rau, internationally renowned practitioner of so-called alternative medicine (SCAM) and director of his own luxury clinic, the Biomed Centre Sonnenberg. Three days later, Kathrin Pfister is dead. The most likely finding according to the experts: Pfister was injected with a drug that was not authorised in Switzerland at the time, the side effects of which killed her.

Pfister is not the only woman to have lost her life following treatment at the Sonnenberg. Other experts accuse Rau of serious breaches of duty that led to the death of a patient. Rau and another doctor are thus being investigated for involuntary manslaughter.

The events remained hidden from the public for over two years. It’s not just about one doctor, not just about one clinic. The events are politically explosive for Appenzell Ausserrhoden. The canton is the centre of alternative medicine in Switzerland. SCAM doctors are an important economic factor in Ausserrhoden. Wealthy people from all over the world fly here for therapies that most conventional doctors just shake their heads at. Treatments lasting several weeks with a hotel stay cost five-figure sums.

The 73-year-old Dr Rau is the star among Swiss alternative medicine practitioners.He describes himself as the “Mozart of medicine”. The Biomed Centre Sonnenberg is “Mozart’s” last big project. The clinic has a hotel and gluten-free vegan restaurant from the Tibits chain. Even the feather pillows are replaced with bamboo ones. All for the “detox” that Rau praises.

Kathrin Pfister’s case began in mid-April 2021, just four months after the Sonnenberg centre opened. She is actually healthy and comes to the clinic anyway; because of some digestive problems and headaches. The hospital records show that Pfister received infusions. Initially only those containing vitamin C and homeopathic remedies. Then one with artesunate, a preparation against malaria. And finally, on a Friday, Pfister was injected with a solution of alpha-lipoic acid into his bloodstream. The infusion is used in Germany for long-term diabetics with nerve damage. It was not authorised as a medicinal product in Switzerland at the time. According to the forensic experts, it was this substance that was “ultimately causally linked to the death”.

A few hours later, Pfister had severe abdominal cramps. Then pain throughout the body. The number of platelets in her blood drops dramatically. Anxiety sets in at the clinic. The intensive care doctors in Herisau and later at the cantonal hospital in St. Gallen can do nothing more. Pfister had a massive blood clotting disorder. Her liver and kidneys were no longer functioning.

Mary Anne Hawrylak meets Thomas Rau by chance at the clinic that weekend. She too is a patient, recently flown in from the USA. Hawrylak had massive side effects after infusions that Friday. “When I told him about it, he turned white as a sheet, like a ghost,” says Hawrylak. “Doctor Rau told me in horror that I had received the same infusions as ‘Kathrin’ and that he had to test my blood.” The tests showed that her blood platelet count had also dropped, says Hawrylak.

The forensic experts point to a central fact: Alpha lipoic acid can cause blood clotting disorders.  They come to the conclusion that this is “most likely a lethal side effect of a drug”. The use of drugs that are not authorised in Switzerland is legal if they are authorised in a country with a comparable procedure. However, there is no real reason to inject this medication into the bloodstream of healthy people. It was authorised in Germany for diabetes patients with nerve damage. So, Pfister did not have this authorisation.

Experts refer to such applications as “off-label use”.  Off-label treatments should only be carried out “on the basis of valid guidelines, generally recognised recommendations or scientific literature”. The guidelines also require that patients are given comprehensive information about off-label use. This counselling session should be documented in writing. None of this can be found in the clinic’s files. No written consent, no documented risk-benefit assessment, no reference to the risk of blood clotting disorders. The forensic experts state: “The scant documentation from the Sonnenberg Biomed Centre does not contain any corresponding information document.” The question arises as to “whether the medical treatment at the Sonnenberg Biomed Centre was carried out with the necessary medical care”.

Patient Hawrylak also says: “I was not told exactly what was in the infusions. I was never told that the medication was not authorised in Switzerland or that its use was off-label. I spoke to Dr Rau about what had happened to ‘Kathrin’ because I was worried about myself,” says Hawrylak. “He said to me: ‘I don’t think it was the infusions. I think it was the Covid vaccinations.” He only justified this with his “intuition”.

The Pfister case triggered an investigation by the public prosecutor’s office. But what hardly anyone knew at the time was that it was not the first questionable death at the clinic – not even the first in a month. Ruth Schmid*, a 77-year-old Swiss woman, had died just three weeks earlier. In this case, the forensic pathologists accused Rau: He had made mistakes that not even a medical student should have made, thus causing Schmid’s death.

Schmid was also in the clinic for a kind of cure. When she was about to leave, she began to tremble violently and had extreme stomach pains. She screamed “like an animal”, her partner said during the interrogation. Ultrasound examinations were carried out at the clinic and Rau gave Schmid painkillers, including morphine. According to the partner’s statement to the public prosecutor’s office, he asked Rau whether Schmid needed to be taken to hospital. Rau said no. Schmid stayed in the hotel room overnight. The next day – according to Rau, she had been feeling better since the previous evening – she travelled home. According to Rau’s confiscated notes, “she was to report closely” and return in four days. At home, Ruth Schmid fell into a coma-like state overnight. Admitted to Zurich University Hospital in an emergency, Schmid died there of cardiovascular failure due to septic shock.

The Zurich forensic pathologists performed an autopsy on Schmid’s body. Their findings: Schmid had suffered from intestinal paralysis. As a result, bacteria entered her body and poisoned her blood, leading to a heart attack. “From a forensic medical point of view, it is incomprehensible why the attending physician, Dr Thomas Rau, did not carry out appropriate diagnostics.” The irritation of the forensic experts is evident in almost every line. There had been several warning signs of intestinal paralysis. The forensic experts wrote: “This knowledge is taught in medical school and is considered basic knowledge in human medicine.” Rau’s behaviour was “a breach of the doctor’s duty of care”. With timely treatment, the prognosis for intestinal paralysis is excellent. The sad conclusion: Ruth Schmid did not have to die.

During questioning by the public prosecutor’s office, Rau denied any guilt. Schmid had left in “good condition”. There was no causality between what happened in the clinic and the death. The findings and conclusions of the Zurich forensic pathologists were wrong. Schmid did not have intestinal paralysis or septicaemia. He had been able to rule out intestinal paralysis because intestinal noises had been audible in the morning. The dose of morphine had been very small, so that it had had no effect. There were no indications of a serious condition. Rau testified that he had acted professionally, as would be expected of an internal medicine doctor.

In the Kathrin Pfister case, the doctors treating her also deny any culpability and question the forensic medical report. The doctor’s lawyer writes that the criminal investigation will show that there was no breach of the doctor’s duty to provide information. Alpha-lipoic acid was not responsible for the death. The expert opinion is not convincing in terms of method or content: “When analysed in depth, it contains no justification that the use of alpha-lipoic acid was in any way causal for the patient’s death.”

During the hearing on the Pfister case, Rau said that restricting the use of alpha-lipoic acid to diabetics was “a joke” and far too narrowly defined. He claimed that Pfister had polyneuropathy, a complex nerve disease. However, there is no mention of this in the files of Rau’s clinic.

The criminal investigation is ongoing in both cases. But did more happen on the Sonnenberg? A former hospital employee, who independently reported to the police, told the public prosecutor about other hair-raising incidents. During the interrogation, she testified that she had seen a young woman being carried out of the clinic extremely weak after an infusion. Days later, she had overheard parts of a telephone conversation between Rau and the patient’s angry husband which made it clear that the woman had died. The former employee also recounted a conversation with Rau’s wife, who is a trained nurse. She said that she had driven a patient to a hospital in Zurich in a private car with Rau because Rau was determined to take her to a particular specialist. The patient was so unwell that she was afraid the woman would die on the way. If this is true, Rau would have travelled past several hospitals with a seriously ill patient.

Hawrylak has one last memory of Appenzell etched in his memory. The departure. She was just leaving the clinic when Rau wished her good luck: “I could only say to him: I wish you good luck too, Doctor Rau. I think you’re really going to need it.”

*Names were altered.

I was alerted to the updated and strengthened guidance to ensure safer practice by chiropractors who treat children under the age of 12 years that has recently been published by the Chiropractic Board of Australia after considering the recommendations made by the Safer Care Victoria independent review. The Board also considered community needs and expectations, and specifically the strong support for consumer choice voiced in the public consultation of the independent review.

The Board examined how common themes in the independent review’s recommendations align with its existing regulatory guidance, and used these insights to inform a risk-based approach to updating its Statement on paediatric care. This includes updated advice reinforcing the need to ensure that parents or guardians fully understand their rights and the evidence before treatment is provided to children. ‘Public safety is our priority, and especially so when we consider the care of children’, Board Chair Dr Wayne Minter said.

According to the statement, the Board expects chiropractors to various things, including the following [the numbers in the following passage were added by me and refer to my brief comments below]:

  • inform the patient and their parent/guardian about the quality of the acceptable evidence and explain the basis for the proposed treatment [1]
  • provide the patient and their parent/guardian with information about the risks and benefits of the proposed treatment and the risks of receiving no treatment [2]
  • appropriately document consent, including considering the need for written consent for high-risk procedures [3]
  • refer patients when they have conditions or symptoms outside a chiropractor’s area of competence, for example ‘red flags’ such as the presence of possible serious pathology that requires urgent medical referral to the care of other registered health practitioners [4]

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  1. I know what is meant by the ‘quality of the evidence’ but am not sure what to make of the ‘quality of the acceptable evidence]. Acceptable by whom? In any case, who checks whether this information is being provided?
  2. Imagine the scenatio following this guidance: Chiro informs that there is a serious risk and no proven benefit – which parent would then procede with the treatment? In any case, the informed consent is incomplete because it also requires information as to which conventional treatment is effective for the condition at had [information that chiros are not competent to provide].
  3. Who checks whether this is done properly?
  4. Arguably, all pediatric conditions or symptoms are outside a chiropractor’s area of competence!

In view of these points, I fear that the updated guidance is a transparent attempt of window dressing, yet unfit for purpose. Most certainly, it does not ensure safer practice by chiropractors who treat children under the age of 12 years.

Several newspapers have reported that, in the Paris region and in the Alpes-Maritimes, France, some 175 police officers were mobilized yesterday to arrest of Gregorian Bivolaru, 71, the Romanian guru and founder of the Movement for Spiritual Integration Towards the Absolute (Misa), which became the ‘Atman Yoga Federation’ when it expanded outside Romania.

Bivolaru had already been convicted in Romania of rape of a minor and is wanted by Interpol for trafficking women. He has also been the subject of a judicial investigation in France since July 2023 for “human trafficking, “organized gang confinement”, “rape” and “organized gang abuse”. He presents himself as the “spiritual leader” of the Atman yoga federation, which has branches in some 30 countries. Under the guise of teaching tantric yoga, this sect conditions its female followers to accept sexual relations eliminating any notion of consent. The victims were encouraged to accept sexual relations with the group’s leader and to engage in pornographic practices for a fee in France and abroad.

Twenty-six women were released during the police operation. Gregorian Bivolaru was arrested in a house in Ivry-sur-Seine where he used to receive his followers for tantric yoga “sexual initiations”. A dozen women were also held for days in the Paris region, to be handed over to the guru.

Gregorian Bivolaru’s career began in 1990 in Romania, where he first founded Misa. Accused of human trafficking and tax evasion in his home country, he moved to Sweden, where he was granted political asylum in 2005, along with a new identity. A conspiracy theorist, he has always maintained that the proceedings against him were political and that the Romanian legal system was against him.

In 2016, Gregorian Bivolaru was sentenced to six years’ imprisonment in Romania for raping a minor and extradited from France. He remained in custody for just one year. New charges were brought against him in Finland after six women, members of the Atman yoga federation, filed a complaint for “human trafficking”. This led Helsinki to issue an international wanted notice by Interpol, in 2017.

Subsequently, the sect continued to exist, still under the control of Gregorian Bivolaru, based in the Paris region. Former followers claimed that the man financed his activities by forcing his victims to submit to various forms of prostitution in strip clubs and massage parlors, or by forcing them to take part in pornographic films in Romania, Hungary and the Czech Republic.

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The International Federation of Yoga and Meditation, ATMAN, claims on its website that it is a non-profit organisation and the majority of its members are committed to a non-profit and charitable orientation. ATMAN is providing a basis for communication and cooperation between various traditional yoga schools and genuine spiritual paths worldwide, promoting true spiritual values for the benefit of mankind.

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A website for Tara Yoga states that Gregorian Bivolaru, nicknamed ‘Grieg’, “is the author of the yoga course taught in Tara and our sister schools in the ATMAN Federation. Having dedicated his entire life towards helping people awaken to that which is divine, Grieg is recognised by many as having a high level of enlightenment and spiritual power, and as belonging to the highest category of spiritual guides, bodhaka.”

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Tara is one of the ten Maha Vidyas or goddesses of the Tantric pantheon. She is the embodiment of knowledge, grace and compassion. Tara is the guiding star of all spiritual seekers, helping aspirants at any moment as they navigate ‘samsara’, the ocean of illusion, on the path to self-knowledge.

 

The increasing demand for fertility treatments has led to the rise of private clinics offering so-called alternative medicine (SCAM) treatments. Even King Charles has recently joined in with this situalion. One of the most frequently offered SCAM infertility treatment is acupuncture. However, there is no good evidence to support the effectiveness of acupuncture in treating infertility.

This study evaluated the scope of information provided by SCAM fertility clinics in the UK. A content analysis was conducted on 200 websites of SCAM fertility clinics in the UK that offer acupuncture as a treatment for infertility. Of the 48 clinics that met the eligibility criteria, the majority of the websites did not provide sufficient information on:Female infertility DIY acupuncture points【12MH】 - YouTube

  • the efficacy,
  • the risks,
  • the success rates

of acupuncture for infertility.

The authors concluded that this situation has the potential to infringe on patient autonomy, provide false hope and reduce the chances of pregnancy ever being achieved as fertility declines during the time course of ineffective acupuncture treatment.

The authors are keen to point out that their investigation has certain limitations. The study only analysed the information provided on the clinics’ websites and did not assess the quality of the treatment provided by the clinics.
Therefore, the study’s fndings cannot be generalized to the quality of the acupuncture treatment provided by the clinics.

Nonetheless the paper touches on very important issues: far too many health clinics that offer SCAM for this or that indication operate way outside the ethically (and legally) acceptable norm. They advertise their services without making it clear that they are neither effective nor safe. Desperate consumers thus fall for their promises. In the case of infertility, this might result merely in frustration and loss of (often substantial amounts of) money. In the case of serious disease, such as cancer, this often results in premature death.

It is time, I think, that this entire sector is regualted in a way that it does not endanger the well-being, health, or life of consumers.

A German paper reported the following horrific story about a Heilpraktiker, an alternative practitioner without a medical degree:

Starting July 7, Torben K. (46) from Solingen will have to answer to the Wuppertal Regional Court. The Heilpraktiker is said to have injected silicone oil into the penis and testicles of a man († 32) at his request. Shortly thereafter, the patient developed health problems and later died.

The prosecution accuses the Heilpraktiker from Solingen of bodily injury resulting in death and violation of the Heilpraktikergesetz.

According to the report, the victim had traveled to Solingen in June 2019, where the defendant had given him the injection in his apartment.

Back home, the 32-year-old patient suddenly developed shortness of breath, had to be hospitalized, then transferred to the university hospital in Giessen. Seven months after the injection, he is dead. According to the indictment, the patient suffered multiple organ failure as a result of blood poisoning.

Three days of trial are scheduled. The defendant faces up to 15 years in prison.

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I had never heard of intra-testicular injections. So, I did a Medline search and found just two papers of the procedure in human patients:

No 1

Blunt trauma is the most common mechanism of injury to the scrotum and testicle. Surgical exploration with primary repair, hematoma evacuation, and de-torsion are common surgical interventions. A 20-year-old male with no previous medical history presented after a high-speed motor vehicle collision. Ultrasonography demonstrated heterogeneous changes of the tunica albuginea and decreased arterial flow to bilateral testicles. He was subsequently taken to the operating room for surgical exploration, which revealed bilateral mottled testes with questionable viability. Papaverine was injected into each testicle, which resulted in visibly increased perfusion and subsequent preservation of the testicles. Conclusion: Current evidence on the use of papaverine is isolated to testicular torsion. Additional research should be conducted on the use of papaverine in blunt testicular trauma. Papaverine injection may be a valuable treatment option when inadequate perfusion is observed intra-operatively.

No 2:

Purpose: We describe a simple technique to deliver local anaesthetic for percutaneous testis biopsies.

Materials and methods: With the testis held firmly, a 25 gage needle is used to inject lidocaine, without epinephrine, into the skin and dartos superficial to the testis, then the needle is advanced through the tunica albuginea and 0.5 mL to 1.0 mL of lidocaine is injected directly into the testis. The testis becomes slightly more turgid with the injection. A percutaneous biopsy is then immediately performed.

Results: Intra-testicular lidocaine, (without the need of a cord block or any sedation) was used on a total of 45 consecutive patients having percutaneous testicular biopsies. Procedure time was short (averages less than 5 minutes) and anaesthesia was profound. There was no change in the number of seminiferous tubules for evaluation compared to biopsies on men using a cord block. Only 1/45 men had a post-procedure testicular hematoma (this resolved in 4 weeks).

Conclusions: Intra-testicular lidocaine appears to be a simple, rapid and safe method to provide anaesthesia for a percutaneous testis biopsy.

All the other papers on intra-testicular injections were about animal experiments, mostly for exploring means of castration. This renders the above case even more unusual. The Heilpraktiker’s defense might stress that the patient wanted the treatment. That may be so but is it a valid excuse? No, of course not. In my view – and I am just a medic, not a lawyer – the Heilpraktiker is responsible for the treatment regardless of how much the patient insisted on it.

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