The topic was addressed 4 years ago in an article called “The Idolatry of the Surrogate” in The BMJ. One of the authors, Dr. John S. Yudkin is our guest on this new podcast. He’s an emeritus professor of medicine at University College in London. We met at the Preventing Overdiagnosis 2015 conference in Bethesda, Maryland last week.
In that BMJ piece, Yudkin and co-authors Victor Montori and Kasia Lipska wrote:
“Diabetes care is largely driven by surrogates. The US Institute of Medicine defines surrogates as ‘biomarker[s] intended to substitute for a clinical endpoint [and] expected to predict clinical beneﬁt (or harm . . .) based on epidemiologic, therapeutic, pathophysiologic, or other scientiﬁc evidence.’ In diabetes, concentrations of glycated haemoglobin (HbA1c) are used as a surrogate marker for outcomes that are important to patients, such as blindness or amputation. Other surrogates such as blood pressure, lipids, albumin excretion rates, and C reactive protein have been used to predict outcomes of cardiovascular disease and to guide clinical practice in people with or without diabetes. Much of the evidence for clinical interventions is based on their effect on surrogate outcomes rather than those that matter to patients such as quality of life or avoidance of vision loss or renal failure. Moreover, because these ‘hard’ end points generally show much smaller responses to interventions than surrogate markers, many of the widely accepted strategies for diabetes may be based on artificially inflated expectations.”
This is a topic that may confuse the general public, and it’s a topic that has evaded many journalists. As one example of this, in 2014, USA Today published a piece, “Pre-diabetes, diabetes rates fuel national health crisis,” without ever mentioning that just two months earlier The BMJ had published another Yudkin/Montori piece, “The epidemic of pre-diabetes: the medicine and the politics.” Yudkin and Montori began the piece:
“Aldous Huxley wrote that ‘Medical science has made such tremendous progress that there is hardly a healthy human left.’ Changes to the American Diabetes Association (ADA) guidance on the diagnosis of pre-diabetes in 2010 make this statement even more true. If implemented globally the guidance could create a potential epidemic, with over half of Chinese adults, for example, having pre-diabetes, a national burden of around 493 million people.”
Theirs was not a message trivializing the impact of diabetes. Instead, they ended with a call for a different emphasis:
“We need a shift in perspective. It is critically important to slow the epidemic of obesity and diabetes. Rather than turning healthy people into patients with pre-diabetes, we should use available resources to change the food, education, health, and economic policies that have driven this epidemic.”
With that background, here is our interview with Dr. Yudkin, touching on issues for the general public, patients and journalists.
Links to other resources:
Obsessed with glycated haemoglobin and microalbuminuria, diabetologists are like the Children of Israel in the wilderness, worshipping the Golden Calf and ignoring the Voice from Mount Sinai, whose Great Commandment is “First Do No Harm.” John (Yudkin) went on to develop the full Ten Commandments, but was dissuaded from publishing them due to American religious sensitivities:
The New Therapeutics: Ten Commandments
- Thou shalt treat according to level of risk rather than level of risk factor.
- Thou shalt exercise caution when adding drugs to existing polypharmacy.
- Thou shalt consider benefits of drugs as proven only by hard endpoint studies.
- Thou shalt not bow down to surrogate endpoints, for these are but graven images.
- Thou shalt not worship Treatment Targets, for these are but the creations of Committees.
- Thou shalt apply a pinch of salt to Relative Risk Reductions, regardless of P values, for the population of their provenance may bear little relationship to thy daily clientele.
- Thou shalt honour the Numbers Needed to Treat, for therein rest the clues to patient-relevant information and to treatment costs.
- Thou shalt not see detailmen, nor covet an Educational Symposium in a luxury setting.
- Thou shalt share decisions on treatment options with the patient in the light of estimates of the individual’s likely risks and benefits.
- Honour the elderly patient, for although this is where the greatest levels of risk reside, so do the greatest hazards of many treatments.
PLEASE NOTE: This podcast was in production even before a new study was published in the Journal of the American Medical Association this week – a study that led to news coverage claiming that half of all Americans had diabetes or pre-diabetes. I wrote about that yesterday, and included a portion of a telephone interview with Dr. Victor Montori.
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Thanks to Cristeta Boarini for her editing on this podcast.
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