Paying the Piper

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.