This is a favorite topic of mine, which many of my long term patients would know. Two I am particularly are concerned about is the over prescription of Statins (See “The Truth about Statins”on a previous blog) and PPIs like Nexium and others for Reflux. Type in “PPI”in the search engine of my web-site for the reason to get off PPIs. I am well aware of the points he makes below, and this whole last 3 years of Covid is a good example of Pharmaceutical companies doing what they do best. I am restricted in what I can say without being sued, but you can work it out for yourselves. I have given plenty of hints over the last 2 years.

This is my last working day until 9th of January, when I return to work. Have a lovely and blessed Christmas and New year.

Cheers from me for now.

Medical Observer 

 Opinion

The disease guidelines industry: How independent is it, really?

Dr Justin Coleman

24 October 2022

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Australian Doctor recently reported on an expert-written guideline urging Australian GPs to inform patients with mild dementia that a multivitamin supplement had been shown to help.

In the guideline, the product is twice referred to by its generic name Fortasyn Connect, but is sold as Souvenaid.

The wording of the guideline refers to the findings of an RTC involving the supplement and specifically says patients “should be informed of these results and the availability of Fortasyn Connect in Australia”.

You can read the full wording yourself at the end of this article.

The cost of the supplement is not cheap — about $1500 a year. And there are no PBS subsidies given, as I will explain, the paucity of evidence for its efficacy.

But the important point here is that the manufacturer of the product was the sole sponsor of these guidelines and paid for the article’s medical writer.

One of the authors of the guideline, an associate professor at Austin Health, defended the recommendation, telling Australian Doctor: “We were happy to receive the money from the company, Nutricia, but I do not believe there was any influence on the guidelines or the workshop outcomes.”

Authors can and do say that.

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Read more: Experts urge GP action on one million patients with mild cognitive impairment

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I’m not alleging anything deliberately untoward in the creation of this guideline. I don’t have any evidence to say whether there was or not.

But if I had a dollar for every time I heard the same claim, I could afford to sponsor a guideline myself.

After 25 years as a medical editor, I do more claim-checking than most. I have developed a ‘Spidey sense’ for picking statements that stand out as being unusually positive towards a particular medication.

In general, the authors of guidelines are often unaware of their own biases.

They are experts in their field, but for years, they have chosen to upskill themselves surrounded by a sea of pharmaceutical-company-influenced colleagues, on boards, working groups and guideline panels. Like all cultures, it shapes you.

Arguably the most influential guidelines in the world emanate from the US, where 75% of authors declare pharmaceutical conflicts of interest, many of them receive six-figure sums over a career.¹

Most of those guidelines expand disease definitions and suggest we aren’t diagnosing often enough.

Not one of the 16 major guides includes a rigorous assessment of potential harms of overdiagnosis.¹

The sponsoring company pays for everything and everyone, from go to whoa.

They would typically invite a specialist who is on their advisory board to run the show. That chair then helps select co-authors they are familiar with — rarely straying from the small pool of other specialists who inhabit the same pharma-sponsored world.

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Read more: Failure to declare conflicts of interest ‘rife among Australian researchers’

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Typically, co-authors will have career-long relationships with a number of companies rather than just having received a grant for research.

Occasionally, they include a non-conflicted GP or representative of a patient advocacy group.

Very rarely is anyone from ‘outside the tent’ invited; no doctor, epidemiologist or health economist with a history of independent scepticism, who could have drawn the panel’s attention to evidence countering medication-friendly recommendations. This is a missed chance to improve the guidelines for the end users: patients.

Little time (often no page space) is spent considering the harms or costs of medication or the population groups where medication is not recommended.

Add in a professional medical writer and — bingo! — you have a very publishable paper with plenty of useful information, but one that recommends GPs diagnose more and prescribe more.

The article on mild dementia contains much that is useful, yet its very design is unambiguously conflicted.

Both specialists who collated the recommendations are paid members of the advisory board of the sponsor.

Of the eight doctors on the author list, five list multiple pharmaceutical conflicts of interest.

However, when I looked up the Disclosure Australia database (where pharma is mandated to name doctors whom they pay), two of the other three had also received payments from pharmaceutical companies that they chose not to disclose.

That leaves a grand total of one independent GP.

None of that makes the guideline wrong or unethical, yet to me, it sends the strong message that GPs are failing to diagnose up to a million Australians who have mild dementia.

And once we diagnose them, we should discuss the evidence (based on a single small company-sponsored study with a high dropout rate) promoting the sponsors’ particular brand of multivitamin.

The double-blinded trial involved 311 patients aged 55-85 who either received Souvenaid (153) or a same-tasting placebo drink (158); however, only 45 participants remained in the active group by the end of the three-year follow-up.

The authors concluded that the drink slowed cognitive decline and brain atrophy in patients with prodromal Alzheimer’s disease. 

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Related: Cardiology editorials ‘rife’ with financial conflicts

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For me, that sort of study would be unlikely to be included, let alone highlighted, by an independent group.

Yes, the guideline may be worded in a way that doctors are expected only to discuss the evidence for this product rather than actively recommend its use.

But when a doctor mentions any possible therapeutic options in a consult, patients are influenced by an unspoken subtext that the doctor thinks those options are worth following.

Nowhere does the guideline mention cost, number-needed-to-treat or the potential impact of diverting time and resources.

The extent to which conflicts of interests distort expert advice is an age-old chestnut.

But there is a simple fix.

I would like to see all national guidelines that advise doctors about prescription decisions make a substantial shift towards independence, away from the companies that profit from those prescriptions and the specialists they employ.

We owe that to our patients.