June 6, 2007...7:44 am

Statins and Why Patrick Holford Is Breaking My Heart: Part 2

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Patrick Holford regularly accuses scientists, doctors and the pharmaceutical industry of withholding or distorting research findings. In a promotional video for Food is Better Medicine than Drugs Holford casts himself and co-author Jerome Burne as Woodward and Bernstein figures battling against omnipotent forces. Holford espouses a belief in:

full spectrum dominance. [The pharmaceutical industry] literally influence the researchers, the journals, the doctors…So the information we get just simply isn’t the truth.

I’ve spent the last year with top, award-winning, medical journalist Jerome Burne, exposing the truth about the pharmaceutical industry…

We’ve…found that about 20% of drug prescriptions are given to patients for whom there is no evidence that it works at all. For example, statin drugs, designed to lower cholesterol. Almost 20,000 people have to take a statin for 5 years for one less heart attack-that is, if you haven’t already had a heart attack.

Scary stuff. Did they obtain this information by interviewing whistleblowers in dark garages? Did operatives sneak past a fully-operational Death Star to smuggle out documents from high-security data archives of suppressed findings? No. In Food is Better Medicine than Drugs, they refer you to a URL for a news story. Not the openly-published-in-a-journal-study on which the news story was based but the news story. And Holford gets his account of that story wrong-badly wrong-but what else is new?

If we were discussing lesser researchers, one might think that that’s what happens if you were to rely upon scanning a news item rather than taking time to read the original paper.

The URL given in Food is Better Medicine than Drugs no longer works. However, you can use the information in the rest of the reference CBC news: Improved cholesterol drug prescribing habits, medical team advises; 11 April, 2005 to track down the news item. You might recall that Holford claims that:

almost 20,000 people have to take a statin for 5 years for one less heart attack-that is, if you haven’t already had a heart attack.

That is not what the authors claim: The 2003 Canadian recommendations for dyslipidemia management: Revisions are needed. It’s not even what the news item reports:

The ICES team looked at Canadians aged 18 to 74 between 1988 and 1992 who were considered at low risk for heart disease but who qualify for statin therapy under current guidelines. Their goal was to run a reality check, estimating how many such people would need to take the drugs to save one life.

They concluded 19,600 people would have to take the medication for five years to prevent a single death from heart disease. [Emphasis added.]

The news team didn’t report the nuances of the paper accurately (more below) but they did manage to mention that the analysis involved a “low risk” population. However, Holford uses this study as an example of current ineffective and expensive prescribing practices and generalises it to the wider population.

The ICES authors ran a theoretical calculation to estimate how many more people would qualify for statin therapy etc. if new, revised guidelines were to be implemented in an absolutist fashion. More relevantly, the team estimated the Number Needed to Treat (NNT) for an acknowledged low risk or very low risk population, not the more general statin-taking population to which Holford refers, which includes people who may not have had heart attacks but still have higher risk levels, diabetes, kidney disease, relevant family history etc. These are fantastically different populations and might have NNTs that would differ by one to several orders of magnitude.

The ICES authors acknowledge these differences in the paper. What did the authors say about that remarkable, headline-grabbing (and, not to give away the punchline, misreported) calculation?

The number of low-risk people for whom statins are recommended if lifestyle modification fails to achieve target lipid levels increased 10-fold, from 61 000 to 595 000. Yet, the relative benefit of statin therapy for many people in the low-risk group is incredibly small. By our estimates, among the 149 000 Canadians who fall within the highest-risk lowest-risk quartile in this group, the number needed to treat with 5 years of statin therapy to prevent 1 CAD-related death would be 19 600. The number needed to treat to prevent 1 CAD-related death in the low-risk group recommended for statin therapy…would be 1550. [Strikethrough reflects the ICES authors' correction; however, it was immediately obvious from the context in the original. Emphases added.]

So, if you take a group of people who are already low-risk, and you examine the sub-group of these people who have the very lowest risk of all, they have an NNT of 19,600. The NNT for the low-risk group is 1550. So, that’s an order of magnitude of difference within the low-risk group.

Further, the ICES authors estimated the NNT to prevent death. Holford has somehow transformed this into “one less heart attack”. It may seem like a small point, but it isn’t to the person affected or their family: not all heart attacks are fatal. These are very different calculations and would yield (even for this population) a substantially lower NNT than either 19,600 or 1550.

There is considerably more amiss with Holford’s claims but it would be more appropriate to discuss them in a separate post (who knew that there would be so much material arising from a short promotional video?).

Holford regularly accuses scientists and researchers of misrepresenting or distorting research and engaging in cover-ups: this is the more remarkable in the light of his own gaffes concerning premature mortality rates. Holford’s constant refrain is that “the information we get just simply isn’t the truth”. The study that is the source for his remarkable claims about statins is freely available to anyone who cares to read it. Holford is amongst the people who have misreported it and inappropriately generalised the findings.

Holford explicitly chose this statins study to promote his book and to support his argument that Big Pharma is deceiving us into accepting and paying for ineffective drug therapy. We’ve already looked into the substantial costs of Holford’s proposed alternatives which he seems to want people to accept without ever having to proffer an NNT.

If you have any concerns about the appropriateness of statins, then you might be well-advised to discuss them with your GP or similar health professional: you may wish to be guided by Holford. The appropriate use of statins is a hotly-debated topic and recommendations for their role in primary prevention are provisional at best. Consequently, healthcare commentators tend to be cautious both about warnings and optimism, tacking between Scylla and Charybdis so as to avoid creating either undue anxiety or complacency. Sensationalising a message may give attention-grabbing headlines or promotional sound-bites but it may have long term consequences for the public understanding of this issue.

Update Jan 22 2008: Further contributions to the hot-topic of the appropriateness of statins: Business Week Do Cholesterol Drugs Do Any Good/

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