TLDW : "Can you please provide me with the study evidence that this treatment, that is relevant to me, will decrease my all cause mortality"
Dr Paul Mason obtained his medical degree with honours from the University of Sydney, and also holds degrees in Physiotherapy and Occupational Health. He is a Specialist Sports Medicine and Exercise Physician.
Dr Mason developed an interest in low carbohydrate diets in 2011. Since then he has spent hundreds of hours reading and analysing the scientific literature. For a number of years Dr. Mason has been applying this knowledge in treating metabolic and arthritis patients who have achieved dramatic and sustained weight loss and reductions in joint pain.
Dr. Mason is also the Chief Medical Officer of Defeat Diabetes, Australia's first evidence-based and doctor-led program that focuses on the wide range of health benefits of a low carb lifestyle, particularly for those wanting to send into remission pre-diabetes, type 2 diabetes, and other metabolic illnesses.
summerizer
Informed consent and real-world decisions
- Over ~12 months, a few intervention thoughts; focus on evidence and questions at the end.
- Relative had a minor heart attack; cath/angiogram team attempted a stent without prior consent; another patient learned a stent was placed without warning.
- Informed consent is an ethical and professional obligation.
- Consent is not only risks; it also includes realistic benefits and when benefits may be absent.
- Transparent benefit discussion would lead some people to decline some interventions.
Aspirin example: primary prevention drifted ahead of evidence
- Aspirin was recommended for decades for primary prevention until a large "Aspirri" trial found no longer life and substantial harms; routine primary-prevention advice shifted.
- Proving "better than nothing" requires placebo-controlled trials, not comparisons against another active agent.
- A secondary-prevention meta-analysis reviewed >250 papers and recommended lifelong aspirin after heart attack.
- Only a small subset of those trials compared aspirin to placebo.
- Surrogate outcomes are not enough; all-cause mortality is the cleanest outcome when available.
- In the placebo-controlled all-cause-mortality trials, most showed no benefit; the one with benefit used aspirin for about 4 weeks.
- Short-term post-MI clotting risk makes a short-course antiplatelet effect plausible, but that does not justify automatic lifelong use.
Surrogates vs outcomes that matter
- Blood pressure and cholesterol changes are surrogate markers; lower numbers are not automatically safer in every context.
- Evaluate interventions by outcomes that cannot be massaged: all-cause mortality.
Stents and PCSK9 inhibitors under the same standard
- Two large randomized trials with thousands comparing stenting vs no stenting show no mortality benefit and more early adverse events with stenting.
- PCSK9 inhibitors reliably lower cholesterol, but cholesterol is a surrogate; no demonstrated all-cause-mortality benefit on average.
Doctor as teacher; patient as decision-maker
- "Doctor" means teacher; the job is education plus support for the patient's choice.
- Communicate benefits and harms using absolute risk, not relative-risk spin.
- Example: 1% to 2% can be sold as "100% higher", but the absolute change is 1 percentage point.
- Focus on outcomes that matter to patients, especially mortality when data exist.
Uncertainty and population gaps
- Some clinicians reject "difficult" patients; time limits are real, but informed consent still includes evidence on risks and benefits.
- Patient-provided papers can change clinical practice.
- Many drug trials have few or no South Asians, especially women; risk calculators like "MISA" omit South Asians.
- When evidence is missing or unclear, be direct about uncertainty and let the patient decide with the best available data.
References
- [00:03] Effect of Aspirin on Cardiovascular Events and Bleeding in the Healthy Elderly — https://doi.org/10.1056/NEJMoa1805819