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Drugs, Trials, Human Volunteers and மருத்துவ கொலைகள்

This post is due to a discussion that started in the following Blog Post
செம்மலர்: மருத்துவ கொலைகள்

First the disclaimer : Any one landing at this page searching for "drugs" will be disappointed... !!! "Drug" here means the "drug" in medical term

First the basics

How are new drugs evolved. Drugs can be either discovered or Invented.

1. Random Screening - This method has been long discontinued. Drugs like Digitalis, Morphine etc were discovered this way
2. Serendipity - The famous example is diuretics. The latest example is Viagra
3. Molecular modification of the known drug - This is actually an invention rather than discovery
4. Rational Drug Designing - This is also invention.
5. Designing of a prodrug or active drug

So you have a got a new drug. What do you do next

It depends on whether you are an ayuveda practitioner or Allopathy practitioner. If you are an ayurvedic practitioner, you can straight away use that drug on the next patient who walks in.

If you are an allopathy practitioner, you have a lot of restrictions to make sure that you do not harm any one

There are two steps

1. Preclinical evaluation - also called as Animal Studies and
2. Clinical Trials - also called as Human Studies

Preclinical Evaluation involve a group of studies

1. Pharmacodynamic Studies
1. In Vitro
2. In Vivo
   
2. Toxicological Studies
1. Acute Toxicity - To Find LD 50
   
2. Sub Acute Toxicity - Biochemical and Histopathological Changes
   
3. Chronic Toxicity - with rodent and non rodent species
   
4. Special Toxicity
1. Effective on Reproductive Performance - Tests on Mating Behaviour, Fertility, Parturition, lactation, perinatal effects, post natal effects
   
2. Teratogenicity - Test for Skeletal or Visceral Anomaly
   
3. Carcinogenicity
4. Mutagenicity - AMES Test
   
3. Pharmacokinetic Studies - in rats, dogs, monkeys - absoption, distribution , metabolism, excretion, relative bioavailability after oral and IV routes, elimination half life
   
4. Assessment of Safety Index - LD 50 and ED 50
   

Clinical Trials can be grouped in Phases

1. Phase I
   
1. Small Number of Healthy Volunteers (20 to 25)
2. Non Blind or Open Label
3. To determine whether human and animals show significant pharmacokinetic difference
4. To determine the safe and tolerated dose in humans
5. To determine the pharmacokinetics of th drugs in humans
6. To detect any predictable toxicity
   
2. Phase II
1. Early Phase II
1. In 20 to 200 patients
2. Done in Patients with diseases
3. Done by Single Blind Method
4. Done to establish a dose range
5. Done to see the potential therapeutic benefits and side effects
   
2. Late Phase II
   
1. On a larger number of patients
2. Done by Double Blind Method
3. Done to ensure safety and efficacy of the new drug
4. Done to compare the data with a standard Drug
   
3. Phase III
1. Done in a large scale
2. 250 to 1000 plus patients
3. Done by Double Blind Method
4. Randomised Control Trial
5. Sometimes even Cross Over Studies are used
6. After the trial, statistical analysis is performed
7. After that the New Drug Application is issued
   
4. Phase IV
1. Done after the drug gets the application
2. Post Licensing Phase
3. No fixed duration
4. Monitored for several years
   

Now, please bear the following points in mind

• Drugs are poisons in small doses and Poisons are drugs in large doses
• All drugs when taken in Huge dose will kill the person (act as a poison)
• Most of the poisons (including the most lethal of all poisons - botulin toxin) is used as a drug
• All Drugs have side effects. Any thing that has an effect has a side effect. (The principle of Homeostasis La fixité du milieu intérieur est la condition d'une vie libre et indépendante - Constance of the internal environment is the condition for a free and independent life). Even All food substances have side effect. There is NO drug without a side effect. There is no food without effect and side effect. There is a condition called water intoxication. Is sugar in large dose poison. Yes. Is salt in large dose a poison. Yes.
• So should we not take drugs / food as all the drugs/food has effects and side effects...
  
• The answer is you have to weigh the benefits and the adverse effects
• For example, if there is a new drug that decreases the body temperature in five minutes (or faster than paracetamol/calpol/dispirin etc), will you take the drug if that causes your hair to fall ????
• On the other hand, there is no cure for AIDS. If they invent a drug which will cure AIDS, but will cause hair to fall, who will not take ???
• 
  

The fact which most of the people do not know

1. The Animal Studies and Human Studies are made only for Allopathic Drugs. That is the reason the side effects of Allopathic Drugs are known.
   
2. THere are quite a few drugs, which will cure your disease, but give you more side effects. But the pity is that ONLY IF THE DRUG HAS UNDERGONE ALL THESE TRIALS, the doctor will know the Adverse Effects. This is exactly the reason why Ayurveda doctors WRONGLY tell that their drugs do not have any side effects. (more about that in this link)
   
3. 
   

Now coming to the important questions.

Is this legal ??

This is legal, if the proper permission has been obtained from the Drugs Controller, Government of India, New Delhi.

But the most important fact is that the correct phase has to be followed

For those who do not understand this, let me explain in plain language

For example if there is a new car designed, there are two questions to be answered. Will it Run (Efficacy) and will it stop (ie after application of brakes - Safety)

There is a drug. You need to know two thing

1. Is it Safe - free from dangerous adverse effects
2. Does it work - Does this cure the disease

The permission for the clinical trials is for specific tests

If a company gets permission for conducting a Phase III Trial, but conducts Phase I trial, that is illegal

(Any doubts / clarifications can be asked in the comments section)

It takes 60 years for court to decide about Rs 7000

http://www.hindu.com/2007/09/25/stories/2007092559450100.htm

The Supreme Court, bringing to an end a 60-year-old suit, has warned that because of inordinate delays in disposal of cases in courts there is a possibility of people taking the law into their own hands by handing out punishment to criminals.

It has called for urgent steps to be taken by the authorities before the situation gets out of hand.

Only last month Justice A. K. Mathur and Justice Markandey Katju had disposed of a 50-year-old suit and expressed their anguish at the situation: “Because of the delay in disposal of cases people in this country are fast losing faith in the judiciary.”

The same Bench, in the latest order now, said: “We saw in the media news of lynching of suspected thieves in Bihar’s Vaishali district, the gunning down of an under-trial prisoner outside the Patna civil court, and other incidents where people have taken the law into their own hands. This is obviously because many people have started thinking that justice will not be done in the courts due to the delays in proceedings. This is indeed an alarming state of affairs, and we once again request the authorities concerned to do the needful in the matter urgently before the situation goes totally out of control.”

The present appeals by Moses Wilson and others arose out of a suit filed way back in 1947 at Kanyakumari in Tamil Nadu and subsequent proceedings. The suit was for Rs. 7,000.

The Supreme Court Bench in its judgment said: “It is not necessary to give further details of the case because the facts involved are very complicated, stretching over 60 years. Therefore, with the consent of counsel for the parties, we cut short the matter and direct that the entire property which is the subject matter of this litigation be divided into equal shares between the two parties. Half share should be given to the appellants and half should be given to the respondents [Kasturiba and others].”

The Bench directed that the district judge decide within six months which part should go to the appellants and which part should go to the respondents.

“If any person has any grievance against the order passed by the district judge, either party could approach this court for clarification,” the Supreme Court Bench added.

CMO, three doctors suspended in U.P.

From http://www.hindu.com/thehindu/holnus/002200709181341.htm

Lucknow, Sept. 18 (PTI): The Chief Medical Officer of Allahabad and three other doctors have been suspended on charges of laxity in providing quick and proper medical facilities to Chief Justice of India K G Balakrishnan's wife Nirmala during the top judge's recent visit to Allahabad.

Besides, the Chief Medical Superintendent of Tej Bahadur Sapru Hospital in Allahabad Dr R P Singh and three other doctors of the hospital have been transferred on similar charges, official sources said today.

Sources said the CJI's wife had sustained a minor injury on her hand while getting down from her car at the circuit house during her visit on Saturday last following which the CMO was directed to arrange medical assistance for her.

The ambulance team was found missing and the CMO then called a doctor to provide treatment to the CJI's wife but she refused to be treated by him as he was "shabbily dressed and his apron was dirty," the sources said.

On being informed, the Director General of Health ordered an inquiry following which the action had been taken, sources added.

Delete / Modify your "Email to post" mail ID from your address book

If you are accustomed to post articles in your blog by mailing them to the "address" provided by Blogger, please be careful. As per the latest post from Blogger Blog

the blog posts are from bloggers whose machines were compromised by a Trojan horse. These bloggers had their mail2blogger email addresses in their computers' address books (a perfectly legitimate use case), so when the malicious software spammed every address in their address book with its content, a copy of that email was posted to their blog.

Thanjavur Tamil University and Quacks

Click here to read a post in my tamil Blog

What goes a jar tell you ????

You might have already read this but still worth reading again…


A professor stood before his Philosophy class and had some items in front of him. When the class began, wordlessly, he picked up a very large and empty mayonnaise jar and proceeded to fill it with golf balls. He then asked the students if the jar was full. They agreed that it was.

The professor then picked up a box of pebbles and poured them into the jar. He shook the jar lightly. The pebbles rolled into the open areas between the golf balls. He then asked the students again if the jar was full. They agreed it was.

The professor next picked up a box of sand and poured it into the jar. Of course, the sand filled up everything else. He asked once more if the jar was full. The students responded with a unanimous "yes."

The professor then produced two cups of coffee from under the table and poured the entire contents into the jar, effectively filling the empty space between the sand. The students laughed.

"Now," said the professor, as the laughter subsided, "I want you to recognize that this jar represents your life.

"The golf balls are the important things - your God, family, your children, your health, your friends, and your favorite passions - things that if everything else was lost and only they remained, your life would still be full. "The pebbles are the other things that matter like your job, your house, and your car. "The sand is everything else--the small stuff. "If you put the sand into the jar first," he continued, "there is no room for the pebbles or the golf balls. "The same goes for life. "If you spend all your time and energy on the small stuff, you will never have room for the things that are important to you.

"Pay attention to the things that are critical to your happiness.

Play with your children. "Take time to get medical checkups. "Take your partner out to dinner. "Play another 18. "There will always be time to clean the house and fix the disposal.
"Take care of the golf balls first, the things that really matter. "Set your priorities. "The rest is just sand."

One of the students raised her hand and inquired what the coffee represented. The professor smiled. "I'm glad you asked. "It just goes to show you that no matter how full your life may seem, there's always room for a cup of coffee with a friend." Please share this with someone you care about.

I JUST DID.

After MBBS: TNPSC Dept Exams 2007 December

After MBBS: TNPSC Dept Exams 2007 December

Disabled, women not in 50% quota cap: SC

http://timesofindia.indiatimes.com/India/Disabled_women_not_in_50_quota_cap_SC/articleshow/2335836.cms

NEW DELHI: The Supreme Court has said that the 50% cap on reservations mandated by it does not cover the 3% quota in force for the disabled as well as the one that may be introduced for women. This means, the pie for the unreserved categories will shrink further.

The clarification about the 50% ceiling, prescribed by the apex court in 1992 as part of its judgment upholding the Mandal quota for OBCs, came last week from a division bench comprising Justices S B Sinha and H S Bedi.

"The reservation for women and handicapped persons would not come within the purview thereof," said the bench.

The significant ruling implies that general-category applicants have only 47% of vacancies in government jobs to compete for, and that the available pie will further diminish if government were to introduce a quota for women.

The court also ruled against any differentiation among disabled persons. "A disabled is a disabled. The question of making any further reservation on the basis of caste, creed or religion ordinarily may not arise," it said. This would rule out any splintering of special quotas for disabled and any other such 'sub-category' along caste lines in keeping with OBC, SC and ST divisions.

The ruling was part of the verdict by which the apex court struck down a Madhya Pradesh government decision to terminate the employment of general-category disabled candidates under the 3% disabled quota as assistant teachers.

The state initially stood firm saying the reserved posts could be filled by disabled persons from any category, but caved in to litigational pressure from disabled SC students demanding precedence over disabled applicants from the general category. It changed its stand that the recruitment advertisement was not proper as it did not specify whether the recruitment was open to all or for only disabled SC/ST candidates.

The state's turnaround came in for severe criticism from the court, which set aside the MP High Court verdict and ordered restoration of the teachers' posts to disabled persons from the general category.

Under the Persons with Disabilities (Equal Opportunities, Protection of Rights and Full Participation) Act, 1995, the states were obliged to make reservations for disabled persons, which Madhya Pradesh completely lost sight of, the bench said.

The court decision is a warning to the Union and state governments which routinely find it difficult to resist lobbying by reserved category associations. The previous NDA government at the Centre had to cave in to pressure from the parliamentary forums of SC and ST MPs to allow reservation in promotion for reserved-category recruits.

http://www.hindu.com/2007/09/05/stories/2007090562941500.htm

No caste quota for disabled

Legal Correspondent

New Delhi: The Supreme Court has held that no further reservation can be made available to the Scheduled Castes, the Scheduled Tribes or the Backward Classes within the quota for the physically handicapped as the disabled themselves constitute a special class.

“A disabled is a disabled. The question of making any further reservation on the basis of caste, creed or religion ordinarily may not arise,” said a Bench comprising Justices S.B. Sinha and H.S. Bedi.

“A reasonable reservation within the meaning of Article 16 of the Constitution should not ordinarily exceed 50 per cent as has been held by this court in the case of Indra Sawhney vs. Union of India [Mandal case]. However, reservation for women or handicapped persons would not come within the purview of this 50 per cent quota.”

The Bench was setting aside a judgment of the Madhya Pradesh High court upholding the State government’s decision to terminate the services of handicapped persons selected from the “general category” on the ground that only those belonging to the “SC/ST/BC categories” could be appointed under the physically handicapped quota.

The High Court had allowed a petition from “disabled SC students” challenging the selection of candidates from the “general category,” contending that they should be given preference under the handicapped quota. The appeal was directed against this order.

The Madhya Pradesh government issued an advertisement stating vacant posts would be filled up from two categories — one for the SC and ST and the other for handicapped candidates (who were not further classified as belonging to the SC, the ST and the general category)

However, when a contempt petition was filed in the High Court, the State changed its stand and said the word “handicapped” was not mentioned in the heading of the advertisement and that the posts were meant only for the SC and the ST and not for “general category” candidates.

Writing the judgment, Mr. Justice Sinha said, “The Rule of Executive construction was given the complete go-by. Reasonableness and fairness, which is the hallmark of Article 14, was completely lost sight of.”

Indicting the government, the Bench said, “The officers of the State behaved strangely. It [the State] prevaricated only because a contempt proceeding was initiated. It chose to terminate the services of some of the employees who had been appointed. Such a course could not have been taken either in law or in equity.”

The Bench set aside the impugned judgment.

Extension of Joining Time Illegal - Chennai High Court

Details at Doctor and Law