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

malpractice

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One of the favourite arguments of proponents of so-called alternative medicine (SCAM) is that conventional medicine is amongst the world’s biggest killers. The argument is used cleverly to discredit conventional medicine and promote SCAM. It has been shown to be wrong many times, but it nevertheless is much-loved by SCAM enthusiasts and thus refuses to disappear. Perhaps this new and important review might help instilling some realism into this endless discussion? Here is its abstract:

Objective To systematically quantify the prevalence, severity, and nature of preventable patient harm across a range of medical settings globally.

Design Systematic review and meta-analysis.

Data sources Medline, PubMed, PsycINFO, Cinahl and Embase, WHOLIS, Google Scholar, and SIGLE from January 2000 to January 2019. The reference lists of eligible studies and other relevant systematic reviews were also searched.

Review methods Observational studies reporting preventable patient harm in medical care. The core outcomes were the prevalence, severity, and types of preventable patient harm reported as percentages and their 95% confidence intervals. Data extraction and critical appraisal were undertaken by two reviewers working independently. Random effects meta-analysis was employed followed by univariable and multivariable meta regression. Heterogeneity was quantified by using the I2 statistic, and publication bias was evaluated.

Results Of the 7313 records identified, 70 studies involving 337 025 patients were included in the meta-analysis. The pooled prevalence for preventable patient harm was 6% (95% confidence interval 5% to 7%). A pooled proportion of 12% (9% to 15%) of preventable patient harm was severe or led to death. Incidents related to drugs (25%, 95% confidence interval 16% to 34%) and other treatments (24%, 21% to 30%) accounted for the largest proportion of preventable patient harm. Compared with general hospitals (where most evidence originated), preventable patient harm was more prevalent in advanced specialties (intensive care or surgery; regression coefficient b=0.07, 95% confidence interval 0.04 to 0.10).

Conclusions Around one in 20 patients are exposed to preventable harm in medical care. Although a focus on preventable patient harm has been encouraged by the international patient safety policy agenda, there are limited quality improvement practices specifically targeting incidents of preventable patient harm rather than overall patient harm (preventable and non-preventable). Developing and implementing evidence-based mitigation strategies specifically targeting preventable patient harm could lead to major service quality improvements in medical care which could also be more cost effective.

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One in 20 patients is undoubtedly an unacceptably high proportion, but it is nowhere close to some of the extraordinarily alarming claims by SCAM enthusiasts. And, as I try regularly to remind people, the harm must be viewed in relation to the benefit. For the vast majority of conventional treatments, the benefits outweigh the risks. But, if there is no benefit at all – as with some form of SCAM – a risk/benefit balance can never be positive. Moreover, many experts work hard and do their very best to improve the risk/benefit balance of conventional healthcare by educating clinicians, maximising the benefits, minimising the risks, and filling the gaps in our current knowledge. Do equivalent activities exist in SCAM? The answer is VERY FEW?

Treating children is an important income stream for chiropractors and osteopaths. There is plenty of evidence to suspect that their spinal manipulations generate more harm than good; on this blog, we have discussed this problem more often than I care to remember (see for instance here, here, here, here and here). Yet, osteopaths and chiropractors carry on misleading parents to abuse their children with ineffective and dangerous spinal manipulations. A new and thorough assessment of the evidence seems to confirm this suspicion.

This systematic review evaluated the evidence for effectiveness and harms of specific SMT techniques for infants, children and adolescents. Controlled studies, describing primary SMT treatment in infants (<1 year) and children/adolescents (1-18 years), were included to determine effectiveness.

Of the 1,236 identified studies, 26 studies were eligible. Infants and children/adolescents were treated for various (non-)musculoskeletal indications, hypothesized to be related to spinal joint dysfunction. Studies examining the same population, indication and treatment comparison were scarce. The results showed that:

  • Due to very low quality evidence, it is uncertain whether gentle, low-velocity mobilizations reduce complaints in infants with colic or torticollis, and whether high-velocity, low-amplitude manipulations reduce complaints in children/adolescents with autism, asthma, nocturnal enuresis, headache or idiopathic scoliosis.
  • Five case reports described severe harms after HVLA manipulations in 4 infants and one child. Mild, transient harms were reported after gentle spinal mobilizations in infants and children, and could be interpreted as side effect of treatment.

The authors concluded that due to very low quality of the evidence, the effectiveness of gentle, low-velocity mobilizations in infants and HVLA manipulations in children and/or adolescents is uncertain. Assessments of intermediate outcomes are lacking in current pediatric SMT research. Therefore, the relationship between specific treatment and its effect on the hypothesized spinal dysfunction remains unclear. Gentle, low-velocity spinal mobilizations seem to be a safe treatment technique. Although scarcely reported, HVLA manipulations in infants and young children could lead to severe harms. Severe harms were likely to be associated with unexamined or missed underlying medical pathology. Nevertheless, there is a need for high quality research to increase certainty about effectiveness and safety of specific SMT techniques in infants, children and adolescents. We encourage conduction of controlled studies that focus on the effectiveness of specific SMT techniques on spinal dysfunction, instead of concluding about SMT as a general treatment approach. Large observational studies could be conducted to monitor the course of complaints/symptoms in children and to gain a greater understanding of potential harms.

The situation regarding spinal manipulation for children might be summarised as follows:

  1. Spinal manipulations are not demonstrably effective for paediatric conditions.
  2. They can cause serious direct and indirect harm.
  3. Chiropractors and osteopaths are not usually competent to treat children.
  4. They nevertheless treat children regularly.

In my view, this is unethical and can amount to child abuse.

I am sure this press-release of today will be of interest:

Good Thinking, a charity which aims to promote science and challenge pseudoscience, is bringing the action after the PSA acknowledged that multiple members of the Society of Homeopaths continue to offer CEASE therapy – a purported treatment for autism which is targeted particularly at children and which relies on the false notion that autism is caused by vaccination, and can be cured with homeopathic treatments, high-dosage Vitamin C, and dietary restriction.

The PSA has acknowledged that CEASE therapy is potentially harmful and conflicts with the advice of the NHS in several respects, including with regard to the childhood vaccinations for potentially life-threatening conditions. Nevertheless, the PSA decided on April 1st to approve the Society of Homeopaths’ accreditation for a further year.

Michael Marshall, Project Director of Good Thinking, said: “By being part of the PSA’s Accredited Voluntary Register scheme, the Society of Homeopaths and its members – including those who practice CEASE therapy – can point to the PSA’s logo on their websites and marketing materials as a sign that they are competent, trustworthy and safe. But that badge, and the credibility and legitimacy it confers, only carries any meaning if the PSA takes seriously their duty to protect the public from harmful practices.

“For the PSA to acknowledge that members of the Society of Homeopaths are offering a treatment that the PSA themselves recognise as harmful, and which is targeted at a particularly vulnerable group, and to then reaccredit them all the same makes a mockery of the PSA’s whole accreditation scheme. For PSA accreditation to mean anything at all, the public needs to be confident that when the PSA identify potentially harmful therapies, they take the necessary steps to protect the public, rather than accepting it and, effectively, endorsing it”.

The Society of Homeopaths has been part of the PSA’s Accredited Voluntary Register scheme since 2014. The PSA’s decision to accredit the Society of Homeopaths and its subsequent decisions to re-accredit have been the subject of criticism from both autism rights campaigners and those who support evidence-based medicine.

Marshall said: “The PSA encourage members of the public to choose healthcare practitioners which belong to one of its accredited registers, and even have a tool on their site to find accredited practitioners. That advice is fundamentally undermined by the fact that a patient could, via the PSA’s list of accredited practitioners, find themselves consulting with a homeopath who discourages vaccination and believes they can cure children of autism.”

Good Thinking’s action has drawn support from autism campaigners, such as Emma Dalmayne: “We as autistic people, are bombarded with the discriminatory rhetoric that we are in need of a cure. CEASE is not a cure for our neurological difference, and it is proven to be extremely harmful. The PSA should not endorse the Society of Homeopaths while their members offer this harmful therapy. The Society of

Homeopaths are at present allowing their members to mislead the public, which in turn puts vulnerable autistic children in harm’s way.”

If Good Thinking’s Judicial Review is successful, the PSA will likely be required to revisit their decision to reaccredit the Society of Homeopaths, this time paying proper regard to the need to protect the public and in particular autistic children who are the main targets for CEASE therapy.

As a small charity, Good Thinking have appealed for support in funding their Judicial Review, and are urging supporters to contribute to their crowdfunding campaign, at crowdjustice.com/case/gts-cease-psa/.

Additional Quotes:

· Simon Singh, Science Writer and Chair of Good Thinking: “Only this week we saw Prince Charles become a patron of the Faculty of Homeopathy. We have become accustomed to Prince Charles endorsing dangerous quackery, but we expect more of the PSA. The credibility of the PSA is at stake when it allows the Society of Homeopaths to retain accredited status despite their members offering this clearly harmful therapy.”

· Laura Thomason, Project Manager, Good Thinking: “Since 2017 we have raised concerns with the PSA about Society of Homeopaths members practicing CEASE therapy, and how we felt the actions they took to protect the public were wholly inadequate. We were therefore shocked and dismayed to see the PSA reaccredit the Society of Homeopaths, and believe their decision to do so, in the absence of any real sign from the Society that they are taking the protection of autistic children seriously, to be unlawful.”

· Professor Edzard Ernst: “According to the ‘like cures like’ principle of homeopathy, Dr Tinus Smits, the Dutch homeopath who invented CEASE, claimed that autism must be cured by applying homeopathic doses of the substances which allegedly caused the condition. CEASE therapists thus ‘detoxify’ all assumed causative factors – vaccines, regular medication, environmental toxic exposures, effects of illness, etc. – with homeopathically prepared substances that were administered prior to the onset of autism. The assumptions of CEASE therapy fly in the face of science. There is also no clinical evidence that CEASE therapy is effective in curing autism or alleviating its symptoms. By misleading desperate parents that CEASE therapy works, homeopaths can do untold harm.”

Tian Jiu (TJ) therapy is a so-called alternative medicine (SCAM) that has been widely utilized in the management of allergic rhinitis (AR). TJ is also known as “drug moxibustion” or “vesiculating moxibustion.” Herbal patches are applied on the selected acupoints or the diseased body part. In TCM, this treatment is said to regulate the functions of meridians and zang-fu organs, warm the channels, disperse coldness, invigorate qi movement, harmonize nutrient absorption and defence mechanisms, and resolve stagnation in the body and stasis of the blood.

But does it work? This single-blinded, three-arm, randomized controlled study evaluated the efficacy of TJ therapy in AR. A total of 138 AR patients were enrolled. The TJ group and placebo group both received 4-weeks of treatment with either TJ or placebo patches for 2 hours. The patches were applied to Dazhui (GV 14), bilateral Feishu (UB 13), and bilateral Shenshu (UB 23) points. Patients received one session per week and then underwent a 4-week follow-up. The waitlist group received no treatment during the corresponding treatment period, but would be given compensatory TJ treatment in the next 4 weeks.

The primary outcome was the change of the Total Nasal Symptom Score (TNSS) after treatment. The secondary outcomes included the changes of Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and rescue medication score (RMS).

After the treatment period, the total TNSS in TJ group was significantly reduced compared with baseline, but showed no statistical difference compared with placebo. Among the four domains of TNSS, the change of nasal obstruction exhibited statistical difference compared with placebo group. The total RQLQ score in TJ group was significantly reduced compared with both placebo and waitlist groups. The needs of rescue medications were not different between the two groups.

There were no serious adverse events. The common adverse events included flush, pruritus, blister, and pigmentation, occurring in 17, 23, 3, and 36 person-times among TJ group, and 3, 7, 1, and 4 person-times among placebo group, respectively. These adverse events were generally tolerated and disappeared quickly after removing the patches.

The authors (from the Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University) concluded that this randomized, single-blinded, controlled trial served primary evidence of the efficacy and safety of TJ therapy on AR in Hong Kong. This pilot study provided a fundamental TJ protocol for future research. Through adjusting treatment timing, frequency, retention time, and even body response settings, it has the potential to develop into an optimal therapeutic method for future application.

The authors of this poorly written paper seem to ignore their own findings by concluding as they do. The fact is that the primary endpoint of this trial failed to show a significant difference between TJ and placebo. Moreover, TJ does have considerable adverse effects. Therefore, this study  fails to demonstrate both the effectiveness and the safety of TJ as a treatment of AR.

PS

I often hesitate whether or not to discuss the plethora such frightfully incompetent research. The reason I sometimes do it is to alert the public to the fact that so much utter rubbish is published by incompetent researchers in trashy (but Medline-listed) journals, passed by incompetent ethics committees, supported by naïve funding agencies, accepted by reviewers and editors who evidently do not do their job properly. Do all these people have forgotten that they have a responsibility towards the public?

It is time to stop this nonsense!

It gives a bad name to science, misleads the public and inhibits progress.

The fact that homeopathy is under siege in France, has been discussed before. Now even the international media have picked up the story. Here are some excerpts from an interesting article in Bloomberg:

… The looming brawl gets to the heart of conflicting visions of the state’s involvement in the country’s health system at a time of eroding quality and services. Jobs are also at stake: France is home to Boiron SA, the leader in a global homeopathy market estimated at more than $30 billion.

Boiron’s pills and tinctures have long coexisted with conventional care in France, prescribed by regular doctors and dispensed in almost every pharmacy. Ending public support for the remedies would discredit homeopathy and “send a shock wave” through the industry worldwide, says Boiron’s chief executive officer, Valerie Poinsot. “We’ve been caught in this storm for the past year,” Poinsot says. “Why the hostility, when we contribute to caring for patients?”

Facing a possible backlash, Boiron, based in Lyon, teamed with rivals Weleda AG of Switzerland and closely held family group Lehning to fund a campaign called MyHomeoMyChoice. The push has garnered just over 1 million signatures in an online petition and placed bright-colored posters framed with the recognizable little white pills at pharmacies across the country. “Homeopathy has treated generations of French patients,” says one slogan. “Why deprive future generations?”

For now, French people can walk into any pharmacy and buy a tube of Arnica granules — recommended for shocks and bruises — or roughly a thousand other similar remedies for 1.6 euros ($1.80) with a prescription, because the state health system shoulders about 30% of its cost. In some cases, private insurers cover the remainder and patients pay nothing. That may all soon change. A science agency is wrapping up a study of the relative benefits of alternative medicine that will inform the government’s position: Keep the funding, trim it or scrap it altogether.

If the government cuts funding, Boiron would instantly feel the pain. Poinsot estimates that sales of reimbursed treatments could plummet by 50% in France, where the company brings in almost half its revenue. The company’s stock price has lost about 13% since May 15, when a French newspaper wrote that the panel reviewing homeopathy funding would probably rule against it…

In France, the controversy first erupted last year when the influential Le Figaro newspaper published a letter from a doctor’s collective called FakeMed lambasting alternative medicines. The authors called for ending support of “irrational and dangerous” therapies with “no scientific foundation.” The ensuing debate prompted Health Minister Agnes Buzyn to place funding under review and ask the country’s High Authority for Health to rule on homeopathy’s scientific merits…

David Beausire, a doctor in palliative care at the hospital in Mont de Marsan, in southwest France, is among those who signed the FakeMed letter. Beausire, who sees many terminally ill patients, said he regularly gets people who consult too late because they first explored alternative medicine paths that include homeopathy. “I am not an extremist,” he says. But homeopathy’s reimbursement by the state health system gives it legitimacy when “there’s no proof that it works.”…

Stung by accusations of quackery, Antoine Demonceaux, a doctor and homeopath in Reims, founded a group called SafeMed last November to relay the message that homeopathy has a role to play alongside standard care. He points to the growing number of cancer centers offering consultations to relieve treatment-related symptoms, such as nausea, with homeopathic medicine. Demonceaux says neither he nor his colleagues would ever use homeopathy as a substitute for treatments intended to, say, shrink tumors. “A general practitioner or a specialist who’d claim to be a homeopath and to cure cancer with homeopathy? Just sack him,” he says. “Let’s get real. We are doctors.”

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On the whole, this is a good report which – as far as I can see – describes the situation quite well and provides interesting details. What, however, with this articles and many like it is this: journalists (and others) are too often too lethargic or naïve to check the veracity of the claims that are being made during these disputes. For instance, it would not have been all that difficult to discover that:

  1. Hahnemann called clinicians who used homeopathy alongside conventional treatments ‘traitors‘! He categorically forbade it and denied that such an approach merits the name ‘HOMEOPATHY’. In other words, let’s get real and let’s not pull wool over the eyes of the public (and let’s be honest, it is not possible to practice homeopathy within the boundaries of medical ethics).
  2. Many homeopaths do advocate homeopathy as a sole treatment for cancer and other serious conditions (see for instance here, here and here).

The obvious risk of such lack of critical thinking is that homeopathy might be kept refundable on the basis of big, fat lies. And clearly, that would not be in the interest of anyone (with the exception of family Boiron, of course).

Time for celebrations and congratulations!

Why?

You might remember the story; over a year ago, I reported that a SCAM practitioner was suing a critic:

‘Doctor’ Colleen Huber (DCH) is the US naturopath who is currently suing Britt Hermes. For me, this is enough reason to do a bit of reading and find out who DCH is and what motivates her. Here is what I found out (I added some * to the quotes [all in italics] and comments below).

DCH has an impressive presence on the Internet. One website, for instance, tells us that DCH is a Naturopathic Medical Doctor* in Tempe, Arizona. Her clinic, Nature Works Best Cancer Clinic, has had the most successful results of any clinic in the world reporting its results over the last 9 years **.

Dr. Huber authored the largest and longest study*** in medical history on sugar intake in cancer patients, which was reported in media around the world in 2014. Her other writing includes her book, Choose Your Foods Like Your Life Depends On Them ****, and she has been featured in the books America’s Best Cancer Doctors and Defeat Cancer. Dr. Huber’s academic writing has appeared in The Lancet *****, the International Journal of Cancer Research ***** and Molecular Mechanisms *****,  and other medical journals ******. Her research interests are in the use of therapeutic approaches targeting metabolic aspects of cancer…

*I am puzzled by this title. Is it an official one? I only found this, and it omits the ‘medical’: Currently, 20 states, five Canadian provinces, the District of Columbia, and the U.S. territories of Puerto Rico and the U.S. Virgin Islands have passed laws regulating naturopathic doctors. Learn more about licensure from the Association of Accredited Naturopathic Medical Colleges. It seems that Arizona is the only state where the ‘medical’ is allowed. However, don’t take this to mean that DCH went to medical school.

** ‘most successful results of any clinic in the world’? Really? Where are the comparative statistics?

*** the study had all of 317 patients and was published in an obscure, non-Medline listed journal.

**** currently ranked  #1,297,877 in Books on Amazon.

***** no such entries found on Medline.

****** sorry, but my Medline search for ‘huber colleen’ located only 2 citations, both on arthritis research conducted in an US Pfizer lab and therefore probably not from ‘our’ DCH.

Another website on or by DCH informs us that her outfit Nature Works Best is a natural cancer clinic located in Tempe, Arizona, that focuses on natural, holistic, and alternative cancer treatments. Our treatments have proved to be an effective alternative to traditional chemotherapy and radiation, which we do not use in our treatments. Rather, we have developed a natural method of treating cancers based on intravenous vitamin therapy which may include Vitamin-C, Baking Soda, and other tumor fighting agents as well as a simple food plan. *

Our team of naturopathic medical doctors have administered an estimated 31,000 IV nutrient treatments, used for all stages and types of tumors. As of July 2014, 80% of patients who completed our treatments alone went into remission, 85% of patients who completed our treatments and followed our food plan went into remission. **

* Give me a break! Vitamin-C and Baking Soda are claimed to have proved to be an effective alternative to traditional chemotherapy and radiation ? I would like to see the data before I believe this!

** Again, I would like to see the data before I believe this!

Finally, a further website proudly repeats that her academic writing has appeared in The Lancet and Cancer Strategies Journal, and other medical journals. It even presents an abstract of her published work; here it is:

Recent recommendations for the more widespread prescription of statin drugs in the U.S. have generated controversy.  Cholesterol is commonly thought to be the enemy of good health.  On the other hand, previous research has established the necessity of cholesterol in production of Vitamin D and steroid hormones, among other purposes, some of which have been shown to have anti-cancer effect.  We compare total serum cholesterol (TC) in cancer survivors vs cancer fatalities, and we assess the value of deliberately lowering TC among cancer patients.  We also examined diet in the survivors as well as those who then died of cancer.

In this original previously unpublished research, we conducted a double-blind retrospective case series, in which we looked back at data from all 255 cancer patients who came to and were treated by our clinic with either current dietary information, and/or a recent serum TC level, measured by an unaffiliated laboratory or an unaffiliated clinic over the previous seven years, comparing TC in the surviving cancer patients versus those cancer patients who died during that time.

Surviving cancer patients had 24.0 points higher mean total cholesterol than the mean for deceased cancer patients.  A number of dietary differences between cancer survivors and those who then died of cancer were also found to be notable.

Caution is advised before attempting to lower cholesterol in cancer patients with close to normal TC levels.  Those cancer patients with higher TC were more likely to survive their cancer.

I don’t know about you, but I am not impressed. Surviving cancer patients had 24.0 points higher mean total cholesterol than the mean for deceased cancer patients. Has DCH thought of the possibility that moribund patients quite simply eat less? In which case, the observed difference would be a meaningless epiphenomenon.

At this point, I stopped my reading; I now knew more than I needed to know about DCH (if you want to read more, I recommend this or this post).

As I mentioned at the beginning of this post, DCH is currently suing Britt Hermes for libel…

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Yesterday Britt Hermes reported that she has won the court case:

On May 24, 2019, the District Court (Landgericht) of Kiel, Germany ruled against naturopathic cancer quack Colleen Huber in a defamation lawsuit she brought against me. Huber filed suit in September 2017 over my opinions about the dubious treatments and human subjects research at her cancer clinic in Tempe, Arizona (USA), and also over my suspicions that Huber was cybersquatting domains in my name…

In a blog post from December 2016, I theorized that Huber or someone in her close orbit had registered domains using my first and last names to misrepresent my position on naturopathic “doctors.” You can view the archive of brittmariehermes.com from 31 March 2016 here. In my post, I also wrote about Huber’s dubious cancer treatments of intravenous baking soda, mega-doses of intravenous vitamin C, and a strict sugar-free diet. Huber advocates against state-of-the-art oncology, especially chemotherapy and radiation, because she thinks these therapies strengthen cancer…

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I am sure that many readers of the blog want to join me in congratulating Britt.

VERY WELL DONE INDEED!

One of the most difficult things in so-called alternative medicine (SCAM) can be having a productive discussion with patients about the subject, particularly if they are deeply pro-SCAM. The task can get more tricky, if a patient is suffering from a serious, potentially life-threatening condition. Arguably, the discussion would become even more difficult, if the SCAM in question is relatively harmless but supported only by scarce and flimsy evidence.

An example might be the case of a cancer patient who is fond of mindfulness cognitive therapy (MBCT), a class-based program designed to prevent relapse or recurrence of major depression. To contemplate such a situation, let’s consider the following hypothetical exchange between a patient (P) and her oncologist (O).

P: I often feel quite low, do you think I need some treatment for depression?

O: That depends on whether you are truly depressed or just a bit under the weather.

P: No, I am not clinically depressed; it’s just that I am worried and sometimes see everything in black.

O: I understand, that’s not an unusual thing in your situation.

P: Someone told me about MBCT, and I wonder what you think about it.

O: Yes, I happen to know about this approach, but I’m not sure it would help you.

P: Are you sure? A few years ago, I had some MBCT; it seemed to work and, at least, it cannot do any harm.

O: Yes, that’s true; MBCT is quite safe.

P: So, why are you against it?

O: I am not against it; I just doubt that it is the best treatment for you.

P: Why?

O: Because there is little evidence for it and even less for someone like you.

P: But I have seen some studies that seem to show it works.

O: I know, there have been trials but they are not very reliable.

P: But the therapy has not been shown to be ineffective, has it?

O: No, but the treatment is not really for your condition.

P: So, you admit that there is some positive evidence but you are still against it because of some technicalities with the science?

O: No, I am telling you that this treatment is not supported by good evidence.

P: And therefore you want me to continue to suffer from low mood? I don’t call that very compassionate!

O: I fully understand your situation, but we ought to find the best treatment for you, not just one that you happen to be fond of.

P: I don’t understand why you are against giving MBCT a try; it’s safe, as you say, and there is some evidence for it. And I have already had a good experience with it. Is that not enough?

O: My role as your doctor is to provide you with advice about which treatments are best in your particular situation. There are options that are much better than MBCT.

P: But if I want to try it?

O: If you want to try MBCT, I cannot prevent you from doing so. I am only trying to tell you about the evidence.

P: Fine, in this case, I will give it a go.

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Clearly this discussion did not go all that well. It was meant to highlight the tension between the aspirations of a patient and the hope of a responsible clinician to inform his patient about the best available evidence. Often the evidence is not in favour of SCAM. Thus there is a gap that can be difficult to breach. (Instead of using MBCT, I could, of course, have used dozens of other SCAMs like homeopathy, chiropractic, Reiki, etc.)

The pro-SCAM patient thinks that, as she previously has had a good experience with SCAM, it must be fine; at the very minimum, it should be tried again, and she wants her doctor to agree. The responsible clinician thinks that he ought to recommend a therapy that is evidence-based. The patient feels that scientific evidence tells her nothing about her experience. The clinician insists that evidence matters. The patient finds the clinician lacks compassion. The clinician feels that the most compassionate and ethical strategy is to recommend the most effective therapy.

As the discussion goes on, the gap is not closing but seems to be widening.

What can be done about it?

I wish I knew the answer!

Do you?

The U.S. Food and Drug Administration posted warning letters to 4 US companies producing homeopathic products for significant violations of current good manufacturing practice (CGMP) regulations, including a letter to King Bio Inc. of Asheville, N.C. The FDA previously warned the public about the agency’s serious concerns with the quality of drug products produced by King Bio.

Please allow me to copy the FDA’s announcement unaltered and without comment:

“In late 2017, the FDA proposed a comprehensive, risk-based enforcement approach to drug products labeled as homeopathic and marketed without the required FDA approval. While the agency continues to examine this approach, the homeopathic industry has continued to grow, and we need to continue to address, consistent with our current enforcement policies, situations where products labeled as homeopathic are being marketed for serious diseases and/or conditions where the products haven’t been shown to offer clinical benefits. We’re committed to continue taking appropriate actions when we believe patients are being put at risk by products that contain potentially harmful ingredients or have significant quality issues. One company that continues to concern us because of the low quality of their operation and the threat their products pose to consumers is King Bio. Despite previous actions we’ve taken, our concerns remain. The warning letter we’re sending is a formal notice to King Bio outlining a number of ongoing, serious violations with their manufacturing operations that must be corrected,” said FDA Commissioner Scott Gottlieb, M.D. “Today we’ve also posted warnings letters to three other homeopathic drug manufacturers for additional concerns we’ve observed – from the use of toxic substances like snake venom that has the potential to cause harm and does not have demonstrated benefit, to other firms whose products we’ve found to be contaminated. These actions build on similar steps we’ve taken over the past year, as we continue to see products labeled as homeopathic that are being marketed without approval for a wide array of diseases and conditions, from chronic pain to cancer. In addition to our concerns with contamination, some products labeled as homeopathic may not deliver any benefit and may have the potential to cause harm. That’s why we’ve proposed a new regulatory approach to prioritize additional enforcement and regulatory actions against certain products labeled as homeopathic. We’re focused on products that have the greatest potential to cause risk to patients, including products for vulnerable populations like children. The actions we’ve taken recently, and over the course of the past year are further warning to all companies that these types of products must be manufactured and labeled appropriately. We’re working to finalize our draft guidance in the coming months to help ensure that products that reach consumers are not harmful to their health.”

Products labeled as homeopathic have not been approved by the FDA for any use and may not meet modern standards for safety, effectiveness and quality. Products labeled as homeopathic can be made from a wide range of substances, including ingredients derived from plants, healthy or diseased animal or human sources, minerals and chemicals. These products are often marketed as natural, safe and effective alternatives to approved prescription and nonprescription products and are widely available in the marketplace. These unapproved drugs may cause significant and even irreparable harm if they are poorly manufactured, which can lead to contamination, or may contain active ingredients that aren’t adequately tested or disclosed to patients, such as belladonna, which the agency has previously warned against.

The warning letter to King Bio Inc. provides details of flaws in manufacturing operations and quality assurance systems found during a July 2018 FDA inspection of the facility. Beyond the violations found during the inspection, the FDA collected and tested samples of finished homeopathic drug products; results revealed inordinately high microbiological contamination. Additionally, evidence collected during the FDA’s inspection indicated recurring microbial contamination associated with the water system used to manufacture drugs. The microbiological contamination of the water system led, in part, to a voluntary recall of more than 900 potentially homeopathic drug products manufactured by King Bio. Following the July 2018 inspection, the FDA alerted consumers and pet owners not to use drug products, including homeopathic drug products, made by King Bio and labeled as Dr. King’s, as these products may pose a safety risk to people (especially infants, children, pregnant women and those with compromised immune systems), as well as pets due to the high levels of microbial contamination identified at the manufacturing site. The company recalled all drug products made with water marketed for humans and animals.

King Bio manufactures a range of products including those for children, adults and pets. Since August 2018, more than 900 potentially contaminated products manufactured by King Bio have been recalled, including those labeled as Aquaflora, Canada, Dr. King’s Natural Medicine(s), Natural Pet, People’s Best and SafeCare. Additionally, other products manufactured by King Bio and distributed by other companies under different brand names were also recalled due to contamination. These include products sold under the brand names Sprayology, Silver Star Brand, HelloLife, Beaumont Bio Med and BioLyte Laboratories.

Today, the FDA also posted warning letters to additional companies for products labeled as homeopathic due to various quality and misbranding violations.

  • Red Mountain Incorporated, Oakland Park, Fla.warning letter for lacking quality oversight while manufacturing homeopathic drug products containing ingredients with potentially toxic effects for consumers, including snake venom.
  • Tec Laboratories Incorporated, Albany, Ore.warning letter for releasing products marketed for use with children, without conducting testing to ensure they were free from objectionable levels of microbial contamination. The company also did not adequately investigate test results that found high microorganism levels in its water system
  • B. Jain Pharmaceuticals Pvt. Ltd., Rajasthan, Indiawarning letter after FDA investigators observed insects in the facility and in ingredients used to make its products.

The FDA has taken similar actions this year, including a warning letter to Nutra Pharma Corp., Boca Raton, Fla.; as announced earlier this month, the FDA issued a warning letter regarding the company illegally marketing unapproved products labeled as homeopathic with claims about their ability to treat addiction and chronic pain; the agency also alerted consumers to this health fraud scam. In February, the FDA issued a warning letter to Pure Source LLC, Doral, Fla. for distributing drugs made with contaminated raw materials.

In December 2017, the FDA proposed a risk-based enforcement approach that prioritizes enforcement and regulatory actions involving drug products labeled as homeopathic and marketed without the required FDA approval that have the greatest potential to cause risk to patients. Given the concerns about the proliferation of potentially ineffective and harmful products labeled as homeopathic, the FDA stated when it issued the draft guidance that it would consider taking additional enforcement and/or regulatory actions, consistent with its current compliance policies, in the interest of protecting the public. We expect to finalize this guidance soon.

The FDA encourages healthcare professionals and consumers to report adverse events or quality problems experienced with the use of any of these products to the FDA’s MedWatch Adverse Event Reporting program.

 

A series of article in The Times yesterday (to which I had made several minor contributions) focussed on the dangers of homeoprophylaxis/homeopathic vaccinations. Sadly, the paper is behind a paywall. I therefore will try to summarise some of the relevant points.

A courageous Times-reporter went under cover to extract some of the anti-vaccination views from a lay homeopath. This particular homeopath happened to charge £330 from customers who want to protect themselves or their family from infectious diseases (£130 for a homeopathic remedy kit, plus £200 for the compulsory instructions via skype that automatically come with the kit). Here are some of the most obvious porkies uttered by that homeopath:

  • Only 30% of healthcare professionals get vaccinated.
  • Rubella is a very mild disease.
  • Cancer patients don’t get fever.
  • Measles mainly kills children with severe disease.
  • Anything which messes with natural immunity could contribute to autism.
  • Health officials devised a seven-step recipe to scare consumers into vaccinating their kids.
  • Fevers should be celebrated.

This new undercover research by the Times is reminiscent of our own investigation of 2002. At the time, we contacted 168 homoeopaths, of whom 104 (72%) responded, 27 (26%) withdrawing their answers after debriefing. We also contacted 63 chiropractors, of whom 22 (44%) responded, six (27%) withdrawing their responses after debriefing.  Only 3% of professional homoeopaths and 25% of the chiropractors advised in favour of the MMR vaccination. Almost half of the homoeopaths and nearly a fifth of the chiropractors advised against it. (This tiny and seemingly insignificant study almost cost me my job: some homeopaths complained to my peers at Exeter University who then, in their infinite wisdom, conducted a most unpleasant investigation into my allegedly ‘unethical’ research; full details of this amazing story are provided in my memoir.)

But perhaps you think that homeoprophylaxis might be effective after all? In this case, you would be mistaken! As discussed a couple of weeks ago, a recent study demonstrated that such treatments are ineffective. Its authors concluded that homeopathic vaccines do not evoke antibody responses and produce a response that is similar to placebo. In contrast, conventional vaccines provide a robust antibody response in the majority of those vaccinated.

The Times article stated that about half of all new parents have been exposed to anti-vaxx propaganda. Consequently, global measles cases have risen by 300% in the first three months of this year compared to last year. Faced with measles outbreaks across the world, it is hard to deny that homeopaths who promote homeopathic vaccinations are a significant risk to public health.

The Times considered the issue sufficiently important to add an editorial. Its opening sentence sums up the issue well, I think: The evidence supporting claims that homeopathic remedies offer an effective alternative to the measles vaccine can be summarised in one word: zero. And its concluding sentences are even clearer: Tobacco companies are obliged to carry prominent public health warnings on their products. Homeopaths should too.

If one agrees with this sentiment, I suggest, we also consider the same for some:

  1. chiropractors;
  2. doctors of anthroposophical medicine;
  3. naturopaths;
  4. doctors practising integrative medicine.

And furthermore I suggest we disregard the many pro-vaccination statements by the professional organisations of these clinicians – they are nothing but semi-transparent fig-leaves and a politically-correct lip services which they neither enforce nor even truly mean.

 

Spinal manipulation has regularly been associated with serious complications, most commonly strokes due to arterial dissections. But there are several other possibilities as well.

A new and unusual case report a serious complication after spinal manipulation has just been published:

A 54-year-old Indian gentleman, presented to hospital with exertional dyspnoea and chest heaviness for the past 6 months which had increased in the last 6 days. Dyspnoea increased on lying down. He was diagnosed as pneumonia on the basis of X-ray and chest CT scan, received treatment for the same and responded to the therapy.

However, breathlessness and hypercapnia persisted. He had unexplained hypercapnia for which extensive investigations were carried out. Neurological and cardiac assessments were essentially normal. On revisit clinical examination, he was found to have paradoxical diaphragmatic movement with respiration. Ultrasound of chest detected no diaphragmatic movement. Detailed history elicited that patient was fond of neck massage and neck cracking wherein his barber would bend his neck with jerk to either side after a haircut.

After considering all possible aetiologies, the authors concluded that this was a case of diaphragm palsy induced by barber neck manipulation, leading to Type-2 respiratory failure. The fact that the vital clues to the diagnosis were elicited by detailed history and thorough examination reinforces that history and clinical examination for doctors shall remain a very important tool for clinical diagnosis.

My chiropractor friends will be relieved, no doubt, to read that, in this incident, a barber rather than a chiropractor caused this unusual incident. Putting my tongue slightly in the direction of my cheek, the story shows me one thing: one does not necessarily have to be a graduate of a chiro-school to cause severe complications with neck manipulations. Occasionally, osteopaths, physiotherapists, doctors and even barbers are capable of the same feast.

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