Towards independence from commercial interests in health

Posted on July 1, 2020 by Dr Ken Harvey

An important collection of resources from the British Medical Journal (BMJ)

Growing evidence shows that extensive financial relationships between industry and healthcare decision makers distort scientific research, medical education and the practice of medicine. The biggest problem is that industry sponsored studies produce more favourable results creating biased evidence that overplays benefits and downplays harms. In response, many individuals and groups around the world are moving towards independence from commercial interests in research, education, practice and policy. This BMJ collection charts and encourages that move.

https://www.bmj.com/commercial-influence

Editorials

Commercial interests, transparency, and independence
Ray Moynihan, Helen Macdonald, Carl Heneghan, Lisa Bero & Fiona Godlee

Declaring interests and restoring trust in medicine
Carl Heneghan & Margaret McCartney

Industry influence in indoor tanning research
Jerod Stapleton & Joel Hillhouse

Financial relations between leaders of US medical societies and industry
Jake Checketts & Matt Vassar

Commercial influence and covid-19
Ray Moynihan, Helen Macdonald, Lisa Bero & Fiona Godlee

Analysis

Pathways to Independence: towards producing and using trustworthy evidence
Ray Moynihan, Per Vandvik, Beate Wieseler, et al.

Improving researchers’ conflict of interest declarations
Quinn Grundy, Adam G Dunn & Lisa Bero

Research

“Asset exchange”—interactions between patient groups and pharmaceutical industry
Lisa Parker, Alice Fabbri, Quinn Grundy, Barbara Mintzes & Lisa Bero

Effect of revealing authors’ conflicts of interests in peer review: randomized controlled trial
Leslie John, George Loewenstein, Andrew Marder & Michael Callaham

Association between gifts from pharmaceutical companies to French general practitioners and their drug prescribing patterns in 2016: retrospective study using the French Transparency in Healthcare and National Health Data System databases
Bruno Goupil, Frédéric Balusson, Florian Naudet, et al.

Association between financial links to indoor tanning industry and conclusions of published studies on indoor tanning: systematic review
Lola Adekunle, Rebecca Chen, Lily Morrison, et al.

Mixed methods evaluation of workshops for citizen health advocates about financial conflicts of interests in healthcare
Ray Moynihan, Alice Fabbri, Lisa Parker & Lisa Bero

Financial ties between leaders of influential US professional medical associations and industry: cross sectional study
Ray Moynihan, Loai Albarqouni, Conrad Nangla, Adam Dunn, Joel Lexchin, & Lisa Bero

Opinion

I’m more susceptible to drug company money that I’d like to be
Lisa Parker

Cochrane announces a new, more rigorous “conflict of interest” policy
Karla Soares-Weiser

The sun is shining on the South: advocacy and regulation of conflicts of interest in Chile
Bernardo Aguilera, Juan Carlos Almonte & Rodrigo Irarrázaval

Can expert bias be reduced in medical guidelines?
Sheldon Greenfield

The world’s most influential medical leaders are still dining on pharma’s pizza
Ray Moynihan

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TGA stakeholder survey 2019

Posted on June 30, 2020 by Dr Ken Harvey

Perceptions of the regulation of complementary medicines: GPs & consumers

This 2019 survey follows the first TGA (2018) survey of consumer perceptions about the regulation of complementary medicines. GPs were not surveyed in 2018. Pharmacists have yet to be surveyed. The results speak for themselves. It is suggested that such surveys should be a regularly repeated TGA key performance indicator (KPI).

For general practitioners, Qualtrics surveyed a validated sample of 138 current general practitioners (excluding those in the medical products industry) who had heard of the TGA before participating in the survey. Fieldwork for the general practitioner survey was conducted between 24 June and 1 July 2019.

The questions about GPs perception of the regulation of complementary medicines items were prefaced with the following instructions and definitions: ‘Shown below are some statements about complementary medicines (such as vitamins, minerals, herbal or aromatherapy products) that are available in Australia. Please indicate your level of agreement with each statement’.

Table 79. Panel general practitioners – aggregate results – perceptions of complementary
medicines items

The consumer sample was composed of 1,045 adult Australians aged 18 and above. The sample was weighted to achieve broad representation across age, gender, and state-based location. Fieldwork for the panel consumer survey commenced on 21 June 2019 and was completed on 26 June 2019.

The questions about consumer perceptions of complementary medicines items were prefaced with the following instructions and definitions: ‘Shown below are some statements about complementary medicines (such as vitamins, minerals, herbal or aromatherapy products) that are available in Australia. Please indicate your level of agreement with each statement’.

Table 110. Opt-in consumers – aggregate results – perceptions of complementary medicines items

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The TGA and COVID-19: Starting to use its compliance teeth!

Posted on June 22, 2020 by Dr Ken Harvey

Significant changes were made to the advertising framework of therapeutic goods during 2018-19. These included the TGA taking over the advertising complaint system, an updated, legally enforceable, advertising Code and stronger investigative and compliance powers. Yet the TGA initially appeared reluctant to use the powers given, preferring instead to ‘educate’ industry rather than enforce the Therapeutic Goods Advertising Code.

Consumer groups have long argued that penalties, not negotiation, is required for sponsors, advertisers and products who repeatedly violate the rules. To change behaviour, these penalties must outweigh the profit that comes from breaking the law.

The COVID-19 environment has finally stimulated the TGA to action. Marketers never waste a crisis and misleading, deceptive and dangerous advertising claims to prevent or cure COVID-19 have proliferated. These have been accorded high priority by the TGA who are now starting to enforce the Therapeutic Goods Advertising Code using their compliance teeth.

TGA actions have included:

  • Warning letters requiring advertisers to cease and desist advertising within tight timeframes (generally 48 hours).
  • Focusing compliance responses on the most significant breaches, e.g. illegal advertising of unregistered goods or use of restricted or prohibited representations.
  • Stronger enforcement action such as infringement notices.
  • Publication of the details of infringement notices, now being done upon issue rather than upon payment to maximise the deterrence impact.

For example:

Next, what about tackling other areas of consumer concern such as numerous illegal products not on the ARTG, and others that lack evidence such as weight loss, hangover, cognitive enhancement and detox products?

See: Pearls & Irritations – TGA fails to deal with hangover products

Update 8 July 2020

TGA issues fines of nearly $1.8 million for alleged illegal activity in 2019-20

Well done TGA! But how many have paid?

Our desired TGA: Enforcing the Therapeutic Goods Advertising Code using their teeth!

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COVID-19 Scams – ABC update on MMSAustralia

Posted on May 6, 2020 by Dr Ken Harvey

On 5 May 2020, ABC 7:30 (Grace Tobin) reported on the ‘Genesis II Church of Health and Healing’. The Australian branch, MMSAustralia.com.au currently promotes and sells Master Mineral Solution (MMS) – chlorine dioxide (a bleach) as a ‘sacrament of the Church’.

Update 13/05/2020

Update 15/05/2020

  • The TGA infringement notices were issued on the evening of 12 May 2020.
  • At the same time a detailed “immediate notice to cease and desist”  was sent requiring MMS Australia to immediately cease advertising and supplying the product.
  • MMS Australia had until COB, Thursday 14 May to provide written confirmation to the TGA that the advertising has ceased.
  • If the TGA finds that advertising does not cease (for example on the MMS website), the TGA will immediately move to seek an interlocutory injunction against further promotion and supply in the Federal Court of Australia.

Update 28/05/2020

The MMS Australia web site appear to be raising their middle finger to the TGA’s twelve infringement notices totalling $151,200 for the alleged unlawful advertising of Miracle Mineral Supplement. Web site now open for sales via logon.

Update 29/05/2020

TGA initiates court proceedings against MMS Australia and director Charles Barton for alleged unlawful advertising

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COVID-19 Scams: Pulsed Electromagnetic Field Therapy (PEMF)

Posted on May 1, 2020 by Dr Ken Harvey

PEMF Therapy Australia promotes Pulsed Electromagnetic Field Therapy (PEMF) for the ‘Prevention and Healing Coronavirus Infections’ (and also other restricted representations such as diabetes). These devices do not appear to be listed on ARTG; they are therefore being illegally supplied and their promotion is making unapproved restricted representations.

https://www.pemf.com.au/ (taken 01/05/2020)

A search of PubMed for Pulsed Electromagnetic Field Therapy and COVID-19 produced no results. There is some evidence that PEMF can improve fracture healing but studies of PEMF for other conditions are inconclusive, most suggest that more and better conducted scientific trials are needed:

Others have suggested that PEMF is snake oil.

On 24 March 2020, the TGA issued a warning about illegal advertising relating to COVID-19 and stated they would act in relation to the illegal advertising of therapeutic products.

I have asked that the TGA to take immediate action against PEMF Therapy Australia, including ordering a prominent retraction be placed on the home page of their web site and that substantial fines be instituted via infringement notices (Complaint, AC-NK9C4WIV/2020).

See also:

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TGA clears Clive Palmer’s coronavirus ‘cure’ advertisement

Posted on April 30, 2020 by Dr Ken Harvey

It was reported that the Therapeutic Goods Administration (TGA) has dropped its investigation into newspaper advertisements taken out by the former federal politician Clive Palmer which said, ‘hydroxychloroquine was the best hope for those suffering COVID-19’.

Clive Palmer

An advertisement is defined in the Therapeutic Goods Act 1989 Subsection 3(1) as, ‘any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods, including where the statement, pictorial representation or design’.

In my opinion, the following statements on page 5 of Palmer’s 3-page advertisement, taken out in major Australian newspapers ( copied below), are clearly intended to promote the use of the drug:

  • ‘hydroxychloroquine was the best hope for those suffering COVID-19’ and
  • ‘the best treatment for its citizens should the worst occur’ and
  • ‘Mr Palmer said it was critical that the drug remained available in hospitals for those who needed it to treat COVID-19’.

These statements are inaccurate, misleading and not in accord with current scientific opinion.

For example, pages 6 and 7 of the advertisement titled, ‘COVID-19 Response and Action’ (copied below) fail to mention that the early French study that hyped hydroxychloroquine has been discredited. It fails to mention negative trials of the fact that serious adverse events emerged in other trials. See:

A number of trials are ongoing and until these have been peer-reviewed, published and replicated, my view is that it is unethical to promote this drug as Palmer has done. It will create false hope in the community and place pressure on medical practitioners to prescribe inappropriately. It also raises a serious question as to why the TGA dropped its investigation of this matter?

The TGA has apparently chosen to interpret the definition of advertising to mean ‘sale’ which, arguably, is not in accord with the Therapeutic Goods Act.

I have submitted a complaint to the TGA about this advertising (AC-TNBK7OQ6/2020). I have also asked for an explanation of the TGA’s interpretation of the Act in this case.

Update 15/05/2020

At a meeting of the Therapeutic Goods Advertising Consultative Committee (TGACC) held on 14/05/2020, Adjunct Prof John Skerritt, Deputy Secretary, Department of Health explained why the TGA had dropped its investigation into Clive Palmer’s 3-page hydroxychloroquine advertisements that ran in major Australian newspapers from April 28 to May 2, 2020.

Prof  Skerritt said, ‘Taken as a whole, the TGA felt the advertisements primarily promoted Mr Palmer’s efforts in donating hydroxychloroquine rather than hydroxychlorquine itself. The TGA accepted this was a line-ball decision.  

A key factor for TGA was that the product was going into the national medical stockpile and could only be released for clinical trials or use by doctors on the decision of the Chief Medical Officer or Deputy Chief Medical Officer.

It was noted the wording about the drug in the advertisement reflected careful legal crafting. In response to reports of inappropriate off-label prescribing of hydroxychloroquine the TGA placed prescribing restrictions on the drug on 24 March 2020; only certain specialists can now prescribe hydroxychloroquine to new patients.’

Dr Harvey reiterated that inaccurate and misleading statements in the advertisements about hydroxychloroquine were likely to create false hope in the community and had placed pressure on medical practitioners to prescribe inappropriately

See also:

The Age, Saturday, May 2, 2020, Page 5
The Age, Saturday, May 2, 2020, Page 6
The Age, Saturday, May 2, 2020, Page 7
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COVID-19 Scams: MMSAUSTRALIA.COM.AU – Chlorine dioxide

Posted on April 29, 2020 by Dr Ken Harvey

MMSAustralia.com.au currently describes itself as a ‘Ministry of the Genesis II Church of Health and Healing’. It promotes and sells Master Mineral Solution (MMS) – chlorine dioxide (a bleach) as a ‘sacrament of the Church’. For example, ‘Jim Humble Approved formulation of MMS1 is composed of the highest grade 22.4% Sodium Chlorite’. Price $32.50. This is yet another COVID-19 scam.

http://www.mmsaustralia.com.au/index.php

MMSAustralia.com.au links to (and thus endorses) a number of videos, testimonials, protocols and other material invoking Jim Humble that allege that MMS, ‘has proven to restore partial or full health to hundreds of thousands of people suffering from a wide range of diseases. These include prohibited representations such as COVID-19, cancer, coronary heart disease, depression and multiple sclerosis. Humble has published a document, ‘Coronavirus Update (COVID-19)’, that provides a protocol of using MMS for coronavirus.

Mark Grenon, self- described as the Archbishop and founder of the “Genesis II Church of Health and Healing, recently wrote to President Trump saying chlorine dioxide ‘can rid the body of Covid-19’ a few days before the president promoted disinfectant as treatment.

The ‘Church’ provides a $300 video course has that, upon completion, provides a ‘Minister of Health Certificate with Reverend I.D. card’ and a ‘Certificate of Authorization to start a Genesis II Church chapter’. We have two such ‘Reverends’ in Australia:

Genesis II Church RC232 AU
Reverend Peter Greg
PO box 83, Westminster 6061 Australia
E: healthchurch@nym.hush.com
M: 0403 880 869

Genesis II Church RC946
Reverend Francesco Duardo
Sydney, NSW Australia
E: fduardo56@optusnet.com.au
M: 0407 807 907

In August 2009, a Mexican woman travelling with her American husband on their yacht in Vanuatu took Miracle Mineral Solution (MMS) as a preventative for malaria. Within 15 minutes she was ill, and within twelve hours she was dead.

In 2010 the CRP upheld three complaints about MMS by me (and others) and recommended that the advertisements be withdrawn, and a retraction be published.

In 2014, the TGA issued a safety advisory about MMS after a report that four people were hospitalised in Victoria after using the product. The TGA noted that MMS was not approved for any therapeutic use and if used for this purpose can pose a serious risk to health.

In 2019, the U.S. FDA warned consumers about the dangerous and potentially life-threatening side effects of MMS.

On 24 March 2020, the TGA issued a warning about illegal advertising relating to COVID-19 and stated they would act in relation to the illegal advertising of therapeutic products.

On 8 April 2020, the U.S. FDA wrote a warning letter to Mark Grenon, Joseph Grenon, Jordan Grenon, and Jim Humble of the Genesis 2 Church noting that claims on their websites misleadingly represent MMS as safe and/or effective to cure, mitigate, treat, or prevent COVID-19. They were ordered to immediately cease making all such claims.

Regardless, MMS continues to be promoted for COVID-19 and other conditions by MMSAustralia.com.au. This promotion of an unauthorised therapeutic good breaches both the Therapeutic Goods Act and the Therapeutic Goods Advertising Code.

On 29 April 2020, I asked the TGA to take immediate action against this company, including ordering that a prominent retraction be placed on the home page of MMSAustralia.com.au and that significant fines be instituted via infringement notices (Complaint AC-Q6V4DYR1/2020).

http://www.mmsaustralia.com.au/index.php?act=viewProd&productId=103

Update 13/05/2020 – More publicity and TGA Acts

Update 15/05 2020

  • The TGA infringement notices were issued on the evening of 12 May 2020.
  • At the same time a detailed “immediate notice to cease and desist”  was sent requiring MMS Australia to immediately cease advertising and supplying the product.
  • MMS Australia had until COB, Thursday 14 May to provide written confirmation to the TGA that the advertising has ceased.
  • If the TGA finds that advertising does not cease (for example on the MMS website), the TGA will immediately move to seek an interlocutory injunction against further promotion and supply in the Federal Court of Australia.

The MMS Australia web site now shows

https://mmsaustralia.com.au/password

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Pre-approval of advertisements for therapeutic goods ends on 30 June 2020.

Posted on April 19, 2020 by Dr Ken Harvey

Why remove pre-approval?

Pre-approval of advertisements aimed to increase compliance with the Therapeutic Goods Advertising Code. However, it had substantial limitations. It only applied to advertisements for medicines, not medical devices, and only to those in ‘specified media’. The latter were traditional mass media channels, such as television, radio and newspapers. It did not include newer media such as the internet and pay television.

In addition, pre-approval of advertisements in different media were carried out by delegates from two industry associations: Complementary Healthcare Council of Australia (CHC) and Australian Self Medication Industry (now named Consumer Healthcare Products Australia (CHP Australia)). Decisions were not always consistent.

The 2015 Review of Medicines and Medical Devices Regulation recommended that pre-approval of advertisments be stopped in favour of a more self-regulated regime coupled with industry education and stronger compliance powers against misleading advertising.

What’s the problem with removing pre-approval of advertisements?

Consumer protection will be reduced. It was pointed out that the majority of advertisements subjected to the old pre-approval system required changes, sometimes substantial, to make them Code compliant. That education campaigns had been conducted over many years but Code breaches still occurred. That financial penalties for breaches might not outweigh the profit that comes from non-compliant advertising.

So, will removing pre-approval of advertisements from 30 June 2020 produce a spike of non-compliant advertisements? Time will tell!

Will AdCheck (from CHP Australia) help?

https://www.chpaustralia.com.au/AdCheck

AdCheck is a new independent advisory service provided by CHP Australia from 1 July 2020. It offers expert compliance checks for all forms of direct to consumer therapeutic goods advertising. The service can also provide training, as well as support, if an ad receives a complaint.  

If deemed compliant the ad will be issued a unique AdCheck number. This number can be featured within the ad (like previous mandatory pre-approval number) so other stakeholders are aware it has been reviewed. External parties can submit a request to CHP Australia to verify this number and confirm the specific ad was reviewed by AdCheck.

Prevention is better than cure.

https://www.chpaustralia.com.au/AdCheck

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Monash SPHPM Therapeutic Goods and Services Research Group 2020 pre- & post-COVID-19

Posted on April 17, 2020 by Dr Ken Harvey

Our action-orientated research helps consumers and health professionals make more informed choices about medicines and medical devices. We do this by analysing policy, making submissions to government, submitting complaints about unethical practice, encouraging regulators to act, being a credible source of expertise to the media, and advocacy with organisations such as Friends of Science in Medicine, Skeptics, Choice and Consumers Health Forum.

We used to meet face-to face…

Therapeutics goods and services research group team pre-COVID-!9.
Back row: Ken Harvey (Team Leader), Hannah Charles (MD SIP), Malcolm Vickers (MPH research)
Front row: Anjali Kumar (BMedSci honours), Shuyi Wu (BMedSci honours)

But not anymore….

Therapeutics goods and services research group team zooming post-COVID-!9.

Regardless, the team pushes on:

  • Mal Vickers is researching complementary medicines and advertising: The impact of Australian policy pre- and post-July 2018, as part of his MPH studies. He has two papers about his work accepted for publication.
  • Hannah Charles researched the literature for CoQ10 to see if it supported commonly advertised claims for this supplement. She has also followed up complaints about CoQ10 advertisements submitted to the TGA worked up by other students. This was all done in her 6-week MD SIP research attachment which has just finished.
  • Anjali Kumar is researching common indications and advertised claims for probiotics to establish if these are backed by scientific evidence and meet regulatory requirements. She is undertaking a BMedSci honours degree.
  • Shuyi Wu is researching the history of Chinese Traditional Medicine (TCM) and the role of the Chinese government in encouraging its use. She is then evaluating claims made for listed TCM products promoted for COVID-19 and menopause; in particular, the evidence base for the herbal ingredients used. She is also undertaking a BMedSci honours degree.

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COVID-19 Scams: Hydrogen Technologies Pty Ltd

Posted on April 14, 2020 by Dr Ken Harvey

‘GROUNDBREAKING HYDROGEN TECHNOLOGY SHOWS SIGNIFICANT POTENTIAL FOR FIGHTING CORONAVIRUS’

On 14 April 2020 a press release from Hydrogen Technologies Pty Ltd said: ‘Molecular hydrogen and oxygen technology is not only helping open the airways of
Coronavirus victims by reducing the inflammation it causes in the lungs, but it also assists
the immune system and dramatically reduces the oxidative stress in the body that if not
addressed, can lead to multiple organ disfunction and failure. Both hydrogen and oxygen are a bodies key requirement to staying alive and well’. It also said:

‘IMPORTANT NOTE: This machine is not to be referred to as a Medical Device‘

https://www.hydrogentechnologies.com.au/products_applications
Excerpt from video at https://www.hydrogentechnologies.com.au/

The web site also contains a page with videos titled the ‘Top 10’ with claims that molecular hydrogen can assist with heart disease, cancer, chronic obstructive pulmonary disease, accidents, stroke, Alzheimer’s, diabetes, influenza and pneumonia, kidney disease, suicide and mental illness.

I am unaware of any scientific evidence to support these claims. In addition, this list of diseases are restricted or prohibited representations that are not allowed to be advertised. Furthermore, this medical device is not included on the Australian Register of Therapeutic Goods (ARTG).

This promotion breaches numerous sections of the Therapeutic Goods Act 1989 (Compilation 72, 2019) and the Therapeutic Goods Advertising Code (No 2) 2018.

A complaint (AC-8IBKJXKR/2020) has been submitted to the TGA. In my opinion, an urgent retraction order and significant infringement penalties are warranted.

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