Feeds:
Posts
Comments

Posts Tagged ‘bmj’

Forbidden quotes in medicine : Healing shall prevail over harming

Posted in Uncategorized, tagged , , , , , , , , , , , , , on April 9, 2026|

Read Full Post »

Why Superior Scientists, will never rely on Non-Inferiority trials?

Posted in Uncategorized, tagged , , , , , , , , , , , on April 4, 2026|

Statistics is the most advanced form of mathematics by which predictions about the future can be made with some degree of surety.  It is a vital cog linking biology with  maths. However, since the last few decades, an abnormal man made bio-mathematical mutation is being spotted in the field of medical statistics.

Why superior scientists avoid Non Inferiority (NI)trials?

They avoid relying NI -trials due to fundamental statistical, interpretive, and ethical weaknesses that undermine rigorous evidence and patient benefit.

Superiority trial models , reduce bias  towards the null hypothesis and proactively protect against false claims. NI trials just do the opposite. The same issues dilute differences, biasing toward falsely concluding the new treatment is “not unacceptably worse” than the active control by a pre-specified margin . Without a placebo arm, sensitivity cannot be confirmed, and the assumption remains tentative.

Key vulnerabilities In NI trials include arbitrary, manipulable margins that may permit clinically meaningful inferiority. High success rates (>85–95%, especially industry-sponsored) suggesting bias, and risks ( Biocreep) where successive approvals erode standards. “Non-inferior” does not mean equivalent .It can mask statistically significant inferiority. Reporting often deviates from guidelines, with inconsistent margin justification and analyses (ITT vs. per-protocol).

Ethically, NI designs accept potential efficacy loss for unproven gains (convenience, cost, safety) without direct proof, exposing patients unjustifiably in high-stakes areas. They place disproportionate proof burdens on de-escalation or alternatives while entrenching suboptimal standards.

A Lancet Oncology piece highlights this as “the tyranny of non-inferiority trials”:. The authors propose abandoning superiority/NI distinctions for simple “comparative” trials.

Final message

Superior scientists prefer superiority or hybrid designs, or direct comparisons of net patient-centered outcomes .They never go for the NI shortcuts driven by regulatory or commercial pragmatism.

Reference

1.Tannock IF, Buyse M, De Backer M, et al. The tyranny of non-inferiority trials. Lancet Oncol. 2024;25(10):e520-e525. doi:10.1016/S1470-2045(24)00218-3.

2.Beryl P, Vach W. Is there a danger of “biocreep” with non-inferiority trials? Trials. 2011 Dec 13;12(Suppl 1):A29. doi: 10.1186/1745-6215-12-S1-A29. PMCID: PMC3287743.

Read Full Post »

Many second opinions might be wrong too … consume it with caution !

Posted in Uncategorized, tagged , , , , , , , , , , , , , , , , , , , , , , on March 8, 2026|

Getting a second opinion from another expert is a valuable option for our patients when they face a complex decision-making process, especially when a cardiac intervention is advised. No doubt, it is their fundamental rights too.But this could be hard, if the second opinion is sought regarding indication for coronary or interventional procedure.

It is much, much comfortable to concur with the original decision if it is pro -Intervention. (even if it is against your conscience). Vetoing a procedure which was advised by some big hospitals is almost impossible for cardiologists sitting at their office, however experienced they may be. This is because it is sort of going against, the mainstream and defying science as well. Both doctors and physicians are stuck.

I confront such situations often from patients following elite cardiology consults. I had been forthright and genuine and said a firm no or yes to many such procedures . I understood much later, that only a minority of the patients followed my No advice , while invariably they accepted my yes.

After much confabulations , recently, I have made some recalibarations on my values, (decent term for compromise ) despite all the ethical stuff I write in these columns. But, three things I ensure , before giving my opinion which goes against my assessment.

“This procedure is not indicated in the true scientific and moral sense, but 1.If you lack full trust,  or 2. If you are not ready to accept the risks of not doing it, or 3. If the fear (of not doing it ), would nag you constantly, then get it done as per the advice of  the big guys”.

Final message

Until we acquire the courage to express our true opinion , we certainly fall under the tag of medically incompetent.

Very soon, getting a second* or even third opinion may not really matter. Doctors are silently persuaded to follow the guidelines thursted  by  big scientific syndicates along with compulsion to go with patient wish & preference.

*Caution and clarification

Second clinical opinion for helping to arrive at a medical diagnosis  is of immense value and a great thing to do. In fact, doctors themselves ask for it when they are in doubt. This article is about second opinion regarding the appropriateness of various interventional procedures that is defining modern medicine.

Read Full Post »

How is that ? A self prescribed PCI (s-PCI) , is an accepted professional medical decision

Posted in Uncategorized, tagged , , , , , , , , , , , , , , , , , , , , on March 7, 2026|

Decision making  for PCI in chronic CAD continues to be delicate. This is especially true, if the lesion is Intermediate and the plaque vulnerablity is susepcted.

How to tackle this stress positive Intermediate LAD lesion. Functional capacity good. Non-diabetic, mildly elevated lipids. Now, continuing medical management with intensive lipid control is the best possible management. (We have evidence for medical management being good even in significant 90% lesion) Above is a case report from https://www.acc.org/education-and-meetings/patient-case-quizzes/medical-therapy-for-cad

Reassurance is a revascularization equivalent

Sharing a similar experience with one of my patients in his early fifties. After getting a fairly convincing consultation, he accepted medical management. However, guided by both NI & AI, he sought a second opinion to confirm whether my assurance was indeed correct. He underwent FFR and OCT, and both he and his plaque became vulnerable. The FFR was normal. He was too intelligent to ask about the FFR – Stress test discordance, for which his cardiologist had no answer. Still, they did not advise a PCI and the decision was left to him, respecting the current patient-oriented guidelines.

The patient went home empowered but spent sleepless nights, fearing about potential fissures,  in the life sustaining fibrous cap.He believed that he was at the mercy of a 75-micron thin cap covering his plaque. In one of the anxious days,in the following week , he got admitted himself in a posh downtown cardiac center. A as per the guidelines, the patient chose his own pathway for a PCI. Cardiologists obliged piously to his wishes. Now, he feels better. He says he is happy to undergo a self prescribed stent.

I was glad, he had the courtesy to come back and showed the results. I learnt. it costed him 6 Lakhs and his insurance covered it fully. I realised , my 30 minutes reassurance was busted by the insurance card in few minutes. I wasn’t surprised.It’s okay, it’s all in the game. I learned it long ago. Fear* (either spontaneous or induced), the power to decide & affordability are the most powerful determinants of any inappropriate medical procedure.

Learning cardiology from UN & WHO

We have United Nations and WHO, the two global guardians. Any one with average intelligence will agree, these instituions can never bring either peace or health to this world.Let us ensure, the practice guidelines of cardiology doesn’t go that way. We boast ourselves, that we have a strongly evidence based vigorously scrutinized cardiology practice framework. How true it is ? Are we hiding behind pateint preference, and pushing  science to the  background ? Let us be transparent. I think it’s time, the powerful bodies like ACC/ESC should connect all the missing dots. .One important issue  is,  fear or anxiety-driven PCI, which usually overtakes other true indications.

Final message

In an ideal world , reassurance and GDMT , if properly done, should be a revascularization equivalent in most CAD patients .The  reality is, fear* prevails over reassurance, for a variety of reasons.

Postamble

*Anxiety thrives well, in an environment of uncertainty. It is mutually inclusive among both patients and physicians.However  most Professional physicians are expected to tackle it. Still many struggle. Patient : What if the block worsens? Physician: What if the patient comes back with an event and oh .. my pride and practice?  May be, physicians are not to be blamed much. I think. it is all about a unexplained,  biased human mind set. Even a death during an inapproproate Intervention is pardoned off, but an error, raising out of an appropriate medical mangment is rarely forgiven.

Read Full Post »

Science can wait … not the suffering patients!

Posted in Uncategorized, tagged , , , , , , , , , , , on January 14, 2026|

Read Full Post »

AI clinical consults : Beware of machine hallucinations, that could become a permanent medical record of your patients.

Posted in Uncategorized, tagged , , , , , , , , , , on December 6, 2025|

It is predicted, (or already happening ) atleast 30 % of clinical consults happen with AI assistsnce or with completely with machines.

The Initial work up is suggested by the AI bots, even in ER rooms. They may be right in 80% of times. But, who is it to filter and grab those remaining 20%. No one , except a astutely learnt clinician. Unfortunately, there is no super AI to do this job.

Final message

This is the beginning of, a new exciting & dangerous era, for the medical profession. If we are not vigilant or loose our common sense, these bots will soon reach their next destination, ie patient’s bed side.

Reference

BMJ in its current Issue address these  aspects of increasing AI usage in the clinical consults

1. Clinical competencies for using generative AI in patient care BMJ 2025; 391 doi: https://doi.org/10.1136/bmj-2025-085324 

https://doi.org/10.1136/bmj-2025-085324

Read Full Post »

What is the realistic definition for “fact vs fake” news

Posted in Uncategorized, tagged , , , , , , , , , , , on November 18, 2025|

Read Full Post »

Trying to become a truly Professional Physician !

Posted in Uncategorized, tagged , , , , , , , , on August 10, 2025|

.

Post-amble

Are you a professional physician doctor ?

Honestly I am struggling to become one , it is still a long way to go.

Read Full Post »

Trust deficit in medical research and Journals : Need for an unprecedented transparency in declaring conflicts of Interest. 

Posted in Uncategorized, tagged , , , , , , on July 25, 2025|

An Awakening Call to the Guardians of Medical Science

Dr. Venkatesan Sangareddi MD, Former professor of cardiology, Madras medical college,Chennai .India

Medical science remains a cornerstone of human progress, and what we have achieved in the last 100 years is unprecedented. Every one of us is aware that the trust placed in medical research is sacred. Also, the medical profession is expected to remain noble as long as human beings exist. However, as in all walks of life, there must be trade-offs to any positives. Yes, this trust has increasingly become vulnerable, threatened by the pervasive and often subtle influence of conflicts of interest (COI). This is especially explicit in the current medical research landscape.

While the scientific community has made strides in acknowledging and requiring disclosure of COIs, particularly from authors , the measures are proving insufficient. There is a big irony sitting right across us. It is made to look, as if conflicts of Interest (COI) exist only with the authors.

The following article written by the author (Ref 1) calls for an  awakening to every medical journal publishers, regardless of their prestige or impact factor, to recognize their vulnerability . We are expected to adopt a new paradigm of transparency in declaring COI, that extends to every participant in the publication process, including the scientific or ethical committies that approve the study ,the peer reviewers, the publishers and finally to the industries that fund the research.

Reference

1,Click here to download the full paper: A caution: It is a fairly lengthy article. (15 minutes read) Hope the suggestions made in the article are not labeled as unrealistic and possibly crazy as well.

Read Full Post »

Evidence based common sense, is rare entity in medical literature

Posted in Uncategorized, tagged , , , , , , , , , , , , on July 10, 2025|

Read Full Post »

Older Posts »