A Few Years Ago, The Film "I'm Not A God Of Medicine" Caused People To Talk About Generic Drugs. Recently, Another "medicine God" In The Pet Circle Was Exposed And Attracted People's Attention The "Cat Version Drug God" Is A Graduate Student In The Department Of Chemistry Of Fudan University. In 2018, She Found That A Compound Called Gs441524 Had A Miraculous Effect On "cat Abdominal Transmission" Disease. She Synthesized The Compound By Herself Using Her Chemical Expertise And Treated Hundreds Of Sick Cats
Wen Yilin Hu
Then She Tried Unsuccessfully To Apply For The Approval Of A New Veterinary Drug, So She Thought Of A Clever Way To Add The Compound To Another Approved Veterinary Drug For Production And Sales.
She Was Detained By Shanghai Public Security Bureau On April 22, 2024, But She Was Not Convicted Of Selling Such Products.
Pharmacists And Sympathizers Believe That Her Original Intention Is Good, Just To Treat More Sick Cats; The Result Was Also Good And Did Not Cause Social Harm.
Procedural Illegality Is Just A "helpless Choice Under The Background That Drugs Cannot Be Quickly Compliant".
In This Way, It Seems That All Links Of Self-made Veterinary Drugs Are Reasonable, And The Only Unreasonable Is The Slow Approval Mechanism. However, Is The Slow Approval Mechanism Itself Reasonable?
We Can See That The Action Of Cat Version Drug God Is Very Advanced. She Learned About The Compound Through A Paper. The Curative Effect Of This Compound Was Only Tentatively Put Forward, And It Is Still In The Experimental Stage Abroad And Has Not Been Listed.
Her Advance Production And Sale Proved That The Effect Was Good, Which In Turn Promoted The Recognition Of The Drug Abroad.
However, This Happy Success Is Accidental.
A Drug Requires A Long Process From The Publication Of A Paper To The Phase I, II And III Clinical Trials To The Approval And Listing.
Round By Round Trials Are Not Only To Verify The Effectiveness Of Drugs, But Also To Verify Their Safety.
Of Course, We Can See That Many Drugs Have Successfully Passed The Phase III Clinical Trials And Finally Proved Effective And Safe. At This Time, We Think After A While That If We Do Less Rounds Of Trials And Put Them On The Market Earlier, Won't We Save More Patients?
But The Problem Is That Many Drugs Have Not Passed The Test, Or Even If They Have Passed The Effectiveness Test, They Have Been Found With Various Contraindications And Adverse Reactions, So They Must Be Used Carefully.
It Is Precisely Because Human Beings Cannot Predict The Future That We Need To Carry Out Experiments Step By Step.
In The History Of Medicine, Mankind Has Accumulated Many Experiences And Lessons. For Example, The "thalidomide" In That Year Can Effectively Reduce Pregnancy Reaction, But It Is Eager To Be Listed Without Fully Verifying The Side Effects, Which Eventually Led To The Birth Of A Large Number Of Deformed Children And Became A Big Scandal In The History Of Medicine.
Thalidomide Eventually Caused More Than 10000 Infant Malformations, But In Fact It Has Been Sold To Millions Of People. The Teratogenicity Rate Is Not Too High. The Risk May Not Be Found In Dozens Of Hundreds Of Clinical Trials. It May Need To Be Revealed In Phase III Clinical Trials Of Hundreds Or Even Thousands Of People.
Of Course, Even If It Has Passed Phase III Clinical, It Can Not Ensure Absolute Safety And Effectiveness. Therefore, Further Follow-up Studies Such As Phase IV Clinical And Real-world Research Are Needed After The Drug Is Listed, Which Can Be Corrected At Any Time. After All, There Is No Absolute Certainty In The World.
However, Relatively Speaking, It Is A Consensus Reached By Scientists, Legislators And Pharmaceutical Enterprises All Over The World To Set The Level Of Approval And Listing Between Phase III And Phase IV, Which Is A Balance Between Efficiency And Safety.
From This Point Of View, The Cat Version Of Yao Shen's Behavior Is Obviously A Violation Of The Medical Consensus. On The One Hand, The Number Of Hundreds Of Sick Cats She Saved First Is Not Enough, On The Other Hand, She Did Not Follow The Basic Norms Of Medical Experiments, And It Is Estimated That She Did Not Take Standardized Steps Such As Blind Method And Control Group, So It Should Be Reasonable That She Could Not Obtain Approval Immediately.
In Addition, What Is More Difficult To Sympathize With Is That She Seems To Have Deliberately Violated The Bottom Line.
"She Once Learned During The Treatment Of Cats That Some Scientific Research Institutions Treat Cats With Gs441524 In The Name Of 'scientific Research Needs', Otherwise It Is Illegal To Sell Drugs."
She May Feel That This "scientific Research Need" Is Just A Pretext For Empty Head And Brain, But It Is Not.
The Strict Distinction Between "medical Behavior" And "medical Research Behavior" Is A Basic Requirement Of Modern Medical Ethics.
The First Article Of The Belmont Report Issued In 1979 Made This Distinction Clear, And Soon Became The Consensus Of The Global Medical Community.
Medical Treatment And Scientific Research Have Different Requirements And Different Norms, Which Can Not Be Confused.
One Of The Simplest And Most Intuitive Differences Is That Researchers Want To Give Financial Compensation To Volunteer Subjects Participating In Medical Experiments, While Doctors In Turn Make Money From Patients Participating In Treatment.
Who Gives Who Money Is A Simple And Important Distinction.
The Sale Of Cat Version Drug God Together With Manufacturers Is Obviously A Profitable Behavior, Which Has Crossed The Boundary Of Scientific Research And Destroyed The Bottom Line Of Medical Ethics.
From The Perspective Of Medical Ethics, The Cat Version Of Drug God Did Something Wrong.
However, In This Case, Law Enforcers May Not Be Without Problems.
On The One Hand, With The Rapid Development Of Chemistry And Biotechnology, The Speed Of R & D And Iteration Of New Drugs Has Been Accelerating In Recent Years. The Traditional Approval Process Is Indeed Clumsy And Slow At Some Times.
On The Other Hand, The Lag Of Relevant Laws And Regulations Seems To Be More Significant.
For Example, The Charge Against The Drug God Is "the Crime Of Producing And Selling Fake And Shoddy Products", Which Really Makes Sense, But It Doesn't Hit The Nail On The Head. The Fact Is That The Drugs She Sells Actually Work Well.
The Key To The Problem Lies Not In The Drug Itself, But In The Ethics Of Scientific Research And Production Norms.
For The Relevant Acts That Violate Scientific Research Ethics, The Legal Provisions For Supervision And Accountability In China Are Ambiguous, And Many Times The Name Is Not Correct And The Words Are Not Smooth.
With The Rapid Development Of Biochemical Technology, It Is Very Necessary To Formulate More Targeted Laws And Regulations In Time.
(author: Department Of History Of Science, Tsinghua University)
Author: Hu Yilin Source: Wechat Company Of China Science Daily