Category Archives: Why WDDTY is wrong about…

Paying the Piper

(Reblogged with permission from Majikthyse. Please go there to comment)

That guardian of all that’s self-righteous about quackery, the magazine and website What Doctors Don’t Tell You, has its ire well stoked this week. The editors reveal that the famous Clinical Trials Service Unit (CTSU) at Oxford University is funded by the pharmaceutical industry. This apparently is the result of tireless investigation by`nutritionist and wholefood campaigner’ Zoë Harcombe. Not you will note a dietician, but a nutritionist, a title that almost anyone seems qualified to hold these days. I can boil an egg, so I’m a nutritionist. “You got an ology?” But enough of flippancy.

I feel duty bound to explain that Ms Harcombe is a writer who mainly sells books on obesity. Her dedication to the truth might be judged by her false claim to the Daily Mail in 2011 that she was studying for a PhD, as reported by my good friend Ben Goldacre. But we all make mistakes. In Ms Harcombe’s case, a further mistake was not realising what the CTSU actually is.

Presumably she has not heard of contract research organisations (CROs). Most of these are commercial companies to whom health care companies contract out a large part of their research, mainly in clinical trials. They have existed for at least 30 years, and some of them are enormous. The usual modus operandi is for the sponsor to engage the CRO to carry out a clinical trial, providing entire or partial functions. So if the contract is `full service’, the CRO will do everything from writing the protocol to writing the final report. The bits in between would include obtaining all the approvals (regulatory, ethics etc), designing the data capture and processing tools, analysing the data, as well as recruiting all the trial sites and investigators and managing the logistics (eg drug and equipment supplies).

However a lot of these contracts are not full service, and in particular data capture and analysis might well not be contracted out at all, or may be delegated to a different contractor. A lot of sponsors run their own data repositories and insist on CROs feeding data into those. Lots of them do their own analysis, and employ armies of statisticians. So what is the CTSU?

It is in fact a CRO, but more so. Rather than rely on what the CTSU claims (“they would say that wouldn’t they?”), let’s look at what the independent Science Media Centre says. The relevant bit is right at the end:

The CTSU conducts, analyses and interprets its clinical trials and other research independently of industry and other funders, with the datasets held by the CTSU rather than by the funders.

Now I’m sure that text came straight from the CTSU, but some credibility is added by its appearance on an independent and respected site. The point though is that the CTSU goes way beyond the probity of a conventional CRO, by erecting a Chinese wall between sponsor and data. The people paying the piper do not call the tune, because they don’t know what the tune is until it’s played at the end of the whole project. Not only that, but the CTSU has a rigorous policy on payments to individuals. Read it and make up your own mind.

What about the funding issue? Look again at the Science Media Centre page. It’s a list of trials, with sponsors and how much they paid. It is baffling as to why anyone should be surprised or indignant about this. The CTSU is a CRO, albeit academically based (and better for that), with a more than usually rigorous policy on independence from financial bias. The CTSU exists to do trials, it has a world-class reputation for that, and companies will pay for that expertise.

WDDTY is full of righteous indignation because Merck & Co, a major statin manufacturer, is also a major funder of the CTSU. Look at the trials Merck has sponsored. Apart from relatively small amounts unrelated to particular trials, Merck provided £63.9 million for statin trials, but £149 million for trials of other drugs unrelated to statins. Yet WDDTY states (my bold):

Over the past 20 years, the two research bodies* have received £268m donations, including £217m from Merck, a major manufacturer of statins.

(*CTSU and its subsidiary The Cholesterol Treatment Trialists Collaboration)

It is a lie to say this funding comprised `donations’ – it was not. It was perfectly normal business and scientific practice, whereby the CTSU was compensated for carrying out research commissioned to it. There is nothing unusual or suspicious about that.

I am not going to get into detail about whatever the CTSU’s director Sir Rory Collins said about the discredited papers in the BMJ, which grossly overstated the side effects of statins, or about what he said about his sources of funds. I haven’t reviewed the whole saga in detail, but as the CTSU’s funding is so transparent I can’t see how he could have forgotten about most of it.

Regarding the retraction of papers, the Science Media Centre provides some useful sound bites on its news page. I am not sure whether WDDTY is simply careless and incompetent, or deliberately distorts the truth – I suspect the latter. But whatever the motivation, the editors have got it wrong yet again. They say that an independent panel refused to retract the papers that quoted the incorrect data, which is not true. The truth is that the authors of the erroneous studies agreed that they were wrong. What the panel declined to retract were two other papers that referred to the original ones. As you can see from the comments from various experts, opinions are divided as to whether there was a need to retract the derivative papers, although they are pretty much unanimous that statins are very useful drugs that have saved many lives.

WDDTY has studiously avoided saying anything about the research which shows statins to be better tolerated than previously thought. Instead the editors make invalid connections between unrelated facts, and indulge in selective reporting and distortion. A drug company would be quite rightly castigated for such behaviour, but in 40 years I have never come across one that tried anything as bad as this.


Addendum: This is the full post as it appeared on WDDTY’s website on 21st August 2014.


‘Independent’ statin research group funded by drugs industry

A research unit that influenced wider statin use in the UK was all the time being funded by drug companies, including £217m from Merck, one of the largest producers of the cholesterol-lowering drug.
The Cholesterol Treatment Trialists Collaboration (CTT), based at Oxford University and headed by Sir Rory Collins, has been very influential in shifting UK health policy, which this year started to recommend statin use for all over-60s.
The new guidelines, issued by NICE (National Institute for Health and Care Excellence), followed the publication of ‘independent’ studies from CTT that maintained that statins had few side effects but many major benefits. Sir Rory was also highly critical of studies published in the British Medical Journal that claimed the drugs caused side effects in 22 per cent of users. He demanded that the papers were retracted, which an independent review panel refused to do.
All along, Sir Rory claimed that he and the CTT were independent, and that any funding came from charitable sources such as the British Heart Foundation and Cancer Research UK. Even as recently as last March, Sir Rory repeated in an email to the BMJ that the British Heart Foundation was a major funder, and demanded to know who had funded the critical research he wanted withdrawn.
But these have been minor funders of CTT and its parent body, the Clinical Trial Service Unit (CTSU). Over the past 20 years, the two research bodies have received £268m donations, including £217m from Merck, a major manufacturer of statins.
The true picture came to light only after nutritionist and wholefood campaigner Zoe Harcombe uncovered the original documents that outline the CTSU’s funders.

 

 

Aspirin to greater accuracy

Sorry about the bad pun.

Hot on the heels of the John Diamond Challenge, in which WDDTY is busted for peddling nonsense about aspirin, @jdc325 published an article demolishing a related comment also about aspirin.

It’s reproduced below with permission. Continue reading Aspirin to greater accuracy

Why WDDTY is wrong about detox

Detox is a staple of the SCAM industry. It’s mentioned quite often in WDDTY. Any responsible journal must necessarily advise serious caution over detox claims, as Scott Gavura points out in his excellent article The Detox Scam: How to spot it, and how to avoid it.

Important
This article refers to the quack concept, not to legitimate medical detox as used in treating alcoholism and drug abuse. To remove ambiguity, you might want to refer to the medical concept as “detox” and the quack version as “detocks“.
Detox varies between harmless dietary advice and expensive and dangerous interventions. Some of the latter are actively supported by the WDDTY editorial panel (e.g. chelation). Few, if any, WDDTY contributors question the validity of detox, and virtually every discussion of detox in WDDTY falls foul of the red flags Scott Gavura identifies:

1. Our bodies are accumulating toxins

Life-Expectancy-since-1701
See how much healthier we were back in the “good old days”? Life expectancy at birth has only doubled since the mid 18th Century.

One of the perennial problems for SCAM generally is the idea that we have evolved as a species to be routinely deficient in essential ways: it’s ridiculous to claim that a normal balanced diet is substantially deficient in essential nutrients, because if it was, the human body, with its many homeostatic mechanisms,  would have evolved or adapted to cope – and that’s exactly what happens, for example there’s good evidence that dark-skinned people living in Northern latitudes have a greater proportion of bioavailable vitamin D.

Detox  is firmer ground for the quacks, as they can blame everything from the common cold to cancer on nebulous and undefined “toxins” brought on by modern life. If there’s one concept on which the SCAM community can unite, it’s the appeal to tradition. Because, after all, when we lived i mud huts and didn’t use toxic modern medicines and vaccinations, we lived much longer and healthier lives, right?

Gavura puts the persistent belief in detox down to “sympathetic magic” – another way of looking at it, is that it’s the SCAM religion’s version of “original sin”.

The core question, always, has to be: what toxin, at what level, is being addressed? With very few exceptions (notably mercury amalgam in dental fillings, a well-studied non-threat to health) the toxins are not named in WDDTY. You might just as well substitute bogeyman or demons. And if a statement works equally well with any non-specific term replaced by the word demons, as virtually all SCAM statements on toxins do, then it’s likely to be rubbish.

We’d go one further: the word toxins as used in SCAM is fundamentally different to the similarly spelled medical term. We’d advocate replacing it with “toxsins” to accurately reflect the religious nature of this nonsense.

2. Illness is the result of toxins

Again, Gavura zeroes in on the core problem with the claim that illnesses are due to “toxins”: the entire field of epidemiology exists to analyse such links, and vanishingly few of the claimed links between “toxins” and disease are supported by robust epidemiology. And this is one of the weaker forms of evidence – while many people consider epidemiology to be almost magical thanks to the work of Richard DollW and others, it’s much less well understood that the smoking gun in establishing the link between smoking and cancer was provided by other forms of evidence. Epidemiology is extremely valuable in pointing the way, but is quite capable of false positives (e.g the purported reduction of coronary heart disease from hormone replacement therapy).

Gavura offers a fascinating historical perspective on the discarded theory of “autointoxication”, a term apparently first used in the late 19th Century, which again is contradicted by the rather obvious evolutionary success of the human species.

3. Detox treatments remove toxins

It is impossible to improve on Scott Gavura’s headline statement here:

A search of the medical literature for clinical studies of detox kits provides the following result:

No Items Found

There is no credible evidence to demonstrate that detox kits do anything at all. 

This also extends to many of the products sold with the pretence of detox. Milk thistle, colonic irrigation, coffee enemas, homeopathy, chelation (hopefully the bullshit percutaneous type, not the genuinely risky EDTA injections), whatever. Not one of them has any proven benefit n “detoxifying”. The “mucoid plaques” so beloved of colonic cleansers, do not exist. No surgeon or pathologist has ever found one.

The WWDDTYDTY Detox Plan

We’ll be selling our own miracle detox package, based on the Sense About Science advice:

  • Have a glass of water to help you rehydrate.
  • Eat a balanced diet.
  • Get a good night’s sleep.

All suggestions on pricing and packaging gratefully received. Unfortunately we don’t think it’s likely to be quite as lucrative as the treatments the WDDTY editorial panel sell.

Weighing up WDDTY

We’re analysing each use of the word “detox” in WDDTY and checking it against the list above. For each claim, we’ll assess:

  1. Is the toxin named, and a credible measure of its presence in the body proposed?
  2. Is there good evidence that this is widespread and in routine need of therapeutic intervention?
  3. Is there sound evidence that the proposed intervention is effective in reducing the levels of the named toxin?

We’ll keep you posted!

What Doctors Don't Tell You
Why don’t doctors advise you to detox?

Because your liver does that.