Dear netrumians,

the discussion on ethics in medicine development is going with a great speed.

Everything from history to recent problems about the topic are being considered
neatly...
Here are some of my personal views on the same matter..

Ethics in medicine developments....
I would like to say..
Ethical procedures that are performed during medicine developments can be
defined by answering the question....
can the procedures be performed on me or my family member for the same purpose
it is being performed? Can I be a volunteer for same?

If your answer is
yes....Ethical
no....Unethical

in medicine development the ethics can be classified under two groups..

1. Ethics for animals
2.Ethics for humans

I would like take it one by one...

1.Ethics in animals..

A. All of us know about CPCSEA GUIDELINES for animal experimentation..Narendra
has already provided the link for same in his previous mail.

B. There should be ethics regarding REAL NEED (unnecessary repetition) OF ANIMAL
EXPERIMENTATION at
04 faculties related to pharmacology say

i. Pharmacy.. Bpharma,Mpharma

ii. Medical professionals ...MD Pharmacology,

iii. Veterinary pharmacology..MVSc pharmacology

iv. Science ....MSc pharmacology

C. Is it not ethical to replace animal experimentation with SIMULATIONS whenever
possible?

2. Ethics in humans....

A. Human guinea pigs...Indians?

B. Checking worthiness of trial.

C. Unnecessary duplication of trial? Do we really need it?

D. Ethics in marketing new molecules....Offers ...Sponsors to physicians....

E. Irrational medicine use by physicians....Unwarranted polypharmacy with newer
molecules....And telling "nayi dawaa hai..Powerful hai"

F. Unbearable pricing of newer molecules that are essential for common
diseases....

G. Existance of banned drug production...Marketing....

All these issues should be tackled with a strict regulation ("military rule")

these are some of my views.

Regards,

Dr.Kiran Chaudhari
Room No:01
New P.G.Hostel
Govt.Medical College
Nagpur-03
  09860108650

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Hi all,
Myself deepali tehare. 1st year pharmacology resident at G.M.C.
Nagpur. I would like to congratulate Dr.Mira madam & Dr. Thawani sir
for selecting such a good topic for disscusion which will certainly
find some solution. I am also thankul to Dr. Thawani sir not only
for giving  opportunity to express our views but also learn more
through netrum.
Ethics is said to be the science of moral principles;recognised
rules of conduct.Ethics is concerned not only with distinguishing
right from wrong & good from bad but also with commitment to do what
is right or what is good.The concept of ethics is inextricably
linked to that of value,that is enduring belief that influence the
choices we make from among the avilable means.
In medicine development,animal testing is essential to obtain
meaningful data enabling researcher to develop useful drugs.for this
there is need to devise a balanced legislation & guidelines for
animal testing as it is crucial part of preclinical sudy. At the
same time there should be a moral obligation to evolve a system
which will minimise the use of anomals,decrease pain & distress
caused to animals.
It is known fact that pharma industry is reluctant to invest in
research on orphan drus.The reason may be- the condition is too rare
to represent a profitable market OR the condition is more prevalent
in developing countries which are too poor to pay drug prices.
Therefore considerations to be made for avilability of such
treatment for people who are unfortunate to be affected by such rare
disease for which there is treatment but out of reach from these
people.
One important thing to mention that,different localities have
different health needs & priorities. In our country infectious and
vector born diseasea are the major health problem. therefore there
should be strategy for the avilability of medicines according to
severity & magnitude of health problem which will certainly help to
save the lives.

THANK YOU,
Dr. Deepali A. Tehare
    G.M.C.
    Nagpur.

Dear members,

Its nice to receive views on the current discussion

Our young generation of Pharmacologists have given their valuable inputs which shows we all are concern about this issue.

Samidh you have rightly pointed out that principles of ethics should be included right inthe formative years of medical education for common ward procedures by using dummy so as to avoid experimenting on our patients. Although few medical colleges in India (private ones) have started using dummies for I.M., I.V., intubation ,resuscitation procedures.etc ,its bit far for Govt. colleges.

As mentioned by Naren and  Akash regarding animal experiment ,certain guidelines should be followed including given by INSA. Its nice of Naren to give  links for further reading.

 

The recruitment of patients for clinical trial and obtaining informed consent in a country like India where illiteracy and poverty is rampant is questionable as mentioned by vivek. Usually the investigators are supposed to follow the SOPs and IEC members  check on it. In case of any deficiency the IEC members can take objection and similarly monitors can also cross check on the actual functioning of the trial.

 

Yaspal you have raised a valid point regarding publication of results of clincal trial . Usually the rights are with the industry -sponsors and an agreement is made before  the trial starts. And so the results presented by Pharma. company should always be taken with 'pinch of salt'.

Amit has mentioned a very important question of unethical means used for drug promotion and dispensing of prescription only drugs as OTC .We need to educate the consumers, prescibers and pharmacist. We know the regulations are not strict in our country but then as rightly mentioned by Dr Vijay that we have to raise our voice and keep things in right perspective. These forum does provide the  oppurtunity !!!

We would like to have ur views on few more areas like medicine prices, orphan drugs, counterfeit drugs .

 

Dear members Pl. do not forget to put ur names and affilation with the post !!

Mira Desai

Moderator

---

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The NetRUM invited a discussion on "How to make the curriculum
pharmacology adequate for the current needs" from 01-10 Nov 2006
which was moderated by Dr Chetna Desai, Associate Professor in
Pharmacology, B. J. Medical College, Ahmedabad.

A brief summary of the discussion follows:

On Pharmacology as a career:
PG course is the important turning point that gives a specific
direction to the career. Choosing pharmacology for PG over other
specialties should not be the end. There are many options to fine-
tune the career, like super specialty of cardiovascular
pharmacology.  Hence the PG should be given freedom of choice.
(Kiran Chaudhari)

The future prospects of a MD pharmacologist are:
• Academics – teaching and research
• Pharmaceutical industry
• Research scientist
• Consultant to pharmaceutical industry
• Independent  ethics committee
• CRO
• Medicine information center
• Advisory role

What should be included in the curriculum and what should be its
schedule?
The main problem is lack of uniformity of the curricula in various
Indian universities. The MD course and training must be standardized
so that all PGs throughout the country learn the same thing. (Manoj
Swaminathan)
The PGs must have the opportunity to compare their educational
performance with a standard until an acceptable level of proficiency
is attained.

The objectives of PG curriculum should be:
Goals
Institutional
The goal of PG medical education shall be to produce competent
specialists :
i. who shall recognize the health needs of the community, and
carry out professional obligations ethically and in keeping with the
objectives of the national health policy.
ii. who shall have acquired the basic skills in teaching of the
medical and paramedical professionals.
iii. who shall have acquired a spirit of scientific inquiry and
is oriented to the principles of research methodology and
epidemiology.
Departmental
The departmental goal shall be to inculcate a rational and
scientific basis of therapeutics and to promote the cause of
essential medicines and rational therapy.
Objectives
A student who successfully completes M.D. Pharmacology, should
become proficient in all aspects of medicines, and should acquire
skills and knowledge so as to opt for any of the fields for his/ her
future career. A sound knowledge of the subject- core / basic
Pharmacology and clinical pharmacology and practical training that
provides exposure to animal experiments, laboratory instruments, and
Clinical Pharmacology is necessary. (Bharat Gajjar)

Following will be useful for PGs:
• Research methodology
• Literature search
• Biostatistics
• Basic computer skills -  Word, PPP, Excel, graph, tables
• Educational technology –using OHP, communication skills
• Protocol designing, GCP guidelines, conducting , monitoring
clinical trials
• BA / BE studies  and other pharmacokinetic parameters
• Preclinical toxicity studies
• Preparation of informed consent form, ADR form, CRF
• Common poisons and their identification
• Analytical techniques – spectrophotometer, HPLC etc
• Summarizing the research article- preparation of abstract
• Critical evaluation of FDC, medicine promotional literature
(Mira Desai)
The three year tenure of PG can be scheduled semester wise.

First Year: Allotment of PG guide should be time bound taking as
less time as possible. Topic of dissertation should be decided
early. Subject may be of student's interest. Student should select
the topic after conducting a pilot study of the proposed work.
Following should be included during this period:
A. Animal experiments
CPCSEA guidelines, GLP guidelines, handling of animals, care of
animals and animal house duties, animal experiments and toxicity
studies.
B. Clinical trials
Types of trials, ICH- GCP guidelines, Governmental centers doing
clinical trials, protocol writing, pharmacovigilance programme, ADR
monitoring and reporting.
C. Role of PG in UG teaching.

Second Year
  Literature search, IPR and copyright, ethics of publication. The
guide and EC should remove the drawbacks in the planned study with
timely amendments, review dissertation work. The dissertation should
be completed during second year.
• Developing leadership skills by organizing CMEs, workshops
etc.
• Writing research articles, review articles, participating in
E- discussions / conferences and E- publishing.


Third year
This shall be more exams oriented and include
• Publishing the dissertation.
• System wise lectures and tutorials.
• PG activities including seminars, journal club presentation,
GD on recent advances like newer targets, trends, marketed
medicines,  policies related to pharmacology, recent postings on
various sites like of WHO, CDSCO, FDA USA, ICMR etc;. Kiran Chaudhari

Topics and training needing special attention
• Essential medicines (Sarang Deshmukh)
• Pharmaceutical industry scenario in country
• Biostatistics – Narendra Bawechar
• Training in research methodology
• Use of latest software like SPSS, STATA, SAS, Clinical Trial
Software.
• Pharmacoeconomics to identify measures and compare costs,
consequences of pharmaceutical interventions.
• Pharmacovigilance (PGs should be assigned the responsibility
of collecting and maintaining ADR reports).
• Running a clinical trial and doing clinical data management.
               Manoj Swaminathan
The PGs shall be made familiar with various funding agencies like
ICMR, DBT for dissertation and research, WHO for organizing various
workshops / courses etc KiranChaudhari

On Time management:
Time cannot be "managed", but one has to mange with time.
Prioritization, as done in triage in casualty management helps. It
helps to prioritize tasks daily and attend to the prioritized work
accordingly. There can be a change in the priorities on a day-to day
basis. (Vijay Thawani). Maintaining a diary with the tasks listed
out helps. (Mira Desai)

Developing teaching and communication skills among the PG students:
Communication skills have become more relevant these days.
Communication essentially is 2-way process and necessarily involves
feedback. Among the communication skills that the PGs need to be
trained are:
• Improving stage daring, public speaking skills, handling
questions, talking to unknown audience, delivering the topic with
intentional constant distractors, answering questions during the
talk, effective use of A-V media
• Imparting lecturette training (mini presentation - 10
minutes)
• Training in skill improvement through micro teaching: First
give them one easy to master skill with advance announcement of the
skill. Then graduate them to set of two skills per presentation on
the subject given in advance but skill announced one hour before
presentation. Subsequently increase skills to three per topic and
inform the skills to be attempted just 10 minutes before the
presentation. If the performer has not done well then trainer must
demonstrate and then ask the performer to present again. Having done
the basic training then introduce the learnt communication skills in
pharmacology subject presentations like seminars, short topics, GD
so that the learnt skills are put to effective use and mastered. –
Vijay Thawani
• Microteaching is also an effective means of improving our
teaching skills. Chetna Desai
• Students should be taught about effective communication,
making OHP and power point presentations. They should be encouraged
to write research paper and review articles, to attend conferences
and present posters / papers. – Sarang Deshmukh
• GD should be done frequently as they help to improve
knowledge and skills.
• Sharing of information among the PG students of various
institutions should be encouraged through sharing of lectures,
seminars etc. Yashpal Jadeja
• Journal clubs to discuss latest research should be held
periodically.                  Samidh Shah.
Practical Pharmacology:
• In situ / In vivo experiments on animals like Rabbits/Guinea
Pigs/Rats/Mice and large animals like Dogs/Cats when feasible, to
study drug effects.
• In vitro experiments on   isolated organs/tissues (like
guinea pig ileum) for demonstrating drug effect or for bioassays.
Tissue / cell culture techniques.
• Prescription audit (outdoor & indoor) for rational medicine
use and better therapeutic outcome.
• Therapeutic product analysis for rationality of medicine
formulations.
• Critical evaluation of literature on medicine formulations
for providing proper medicine information.
• Human Pharmacology experiments to learn pharmacokinetics and
demonstrate medicine effects. Bharat Gajjar
• Students can be given projects in collaboration with
pharmaceutical industry. Sarang Deshmukh

Many animal experiments have outdated methodology, are outdated and
consume hours to set up. Precise methods and instruments must exist
to save on time and labor. Animal experiments should not be
discarded totally as they are the first steps in medicine discovery.
However these may be reduced. Anupama

There should be some availability of A-V demonstration for the
experiments on dog and cat which are being asked in the exams as
hypothetical exercises. Instruments used in industries are far more
superior to those available in teaching institutions and hence need
to be modernized. AmitKubawat

Dissertation:
• Every PG should carry research project under the guidance of
a recognized PG teacher. The results of such work shall be submitted
in the form of a dissertation.
• Common current topics of dissertation include rational use
of medicines, ADRs, clinical trials, medicine utilization studies.
• The dissertation should be aimed to train the student in
research methodology and techniques. It includes identification of a
problem, formulation of a hypothesis, search and review of relevant
literature, getting acquainted with recent advances, designing
research study, collection of data, critical analysis of results and
drawing conclusions. Topics should be selected in a manner which are
relevant, are local/national problems of priority and remedial
measures should be suggested.  Bharat Gajjar
• In project reports/dissertation/thesis the data can be shown
in tables/ graphs/diagrams. Ensure that there is no monotony in
presentation and it does not give the impression that it has been
done to add extra pages! Have variation and use of colors in
pictorial presentation. Vijay Thawani
Rotational postings during residency – Why, How and When?
• Rather than having 6 months postings there maybe
1 month posting every year. Voluntary postings can be held in
Pharmaceutical industry. Those interested in academics can get
trained in teaching skills. PGs can also visit the community and
help in promoting rational use of medicines  Anupama
• Posting for PGs in medical stores to train them in medical
store management and make them do various analysis like ABC, VED.
• PGs preferring to work in industry can learn the working
inside a retail pharmacy.
• PGs should be posted in medicine store or medicine
information centre, so they can know what medicines are available,
how many are essential and rational. It will also train them in
educating patients about medicine use and ADRs. Samidh Shah
• Postings in clinical departments like medicine and
pediatrics will help study topics like pharmacovigilance and
postings in pharmaceutical industry in the final year of residency.
Narendra Bachewar
• Pharmacology as a PG subject is going through upward surge
because of the immense opportunities in pharmaceutical industries.
There should be some arrangement during the tenure for exposure to
the work environment of the industry, Preetam Gandhi. This can be in
the form of a 3 months posting in research, 2 months posting in CRO -
  for clinical trials and  1 month posting in marketing division of
industry – Akash Patel
• Pharmacology residents may have varied interests and career
plans. Some may want to go the industry, others to CROs, some to
academics etc. The way out might be to offer electives to
postgraduates where the PGs can opt for an elective depending on
their interests and plans. Ravi

Evaluation:
Continued assessment drives the learning. Hence during PG period the
skills acquirement should be rigorously assessed. Self assessment,
peer evaluation, log book / portfolio of the PGs work, written
assessment, oral examination and simulation should be place..
Rigorous assessment has the potential to inspire learning, influence
values, and reinforce competence. Mangesh Banker
• During the study period of 3 years with just final
evaluation at the end, has lack of consistency and commitment from
PGs, Hence periodic exams may be conducted every six months for
continuous involvement and development of sound knowledge and
interest. MCI may have relook on exam structure and pattern. Yashpal
Jadeja
• Our theory exams usually comprise of long and essay type
questions, while the global trend is objective. The advantage with
objective pattern is that it consumes less time, allows revision and
prevents subjective evaluation. Vivek Sharma
• The practical assessment should be based on objective
criteria– Smita Mali
----------------------------------------------------------------
DR KIRAN CHAUDHARI GOT THE BEST POSTING PRIZE IN THIS DISCUSSION.

REPORT OF THE DISCUSSION HELD ON NETRUM ON UG CURRICULUM

Dinesh Parmar felt that the undergrads (UGs) should be trained in
pharmaco-economics with exercises like price comparison of the
different brands of the same medicine and training in irrational
medicine combinations.

Anupama Suklecha, a regular on NetRUM, proposed that training should
be given in prescribing medicines with consideration of efficacy,
safety, suitability, and price. P-drug selection can be taught by
group discussion (GD) in criticizing, correcting and rewriting (CCR)
of the prescription.
Prescription writing being life-long, it should be taught in "UG
package" extending right up to internship. There should be
interactive integrated teaching of medicine, community medicine and
rational prescribing. In the subject of medicine the students should
be examined in rational prescribing. During internship, one week
should be devoted to training in essential medicines (EM), visit to
pharmacies to find various brands available for medicines and
compare them, experience the dispensing practices and medicine
substitution.

Shilpa Jadhav felt that pharmaco-vigilance should be taught and
practical training on ADR reporting should be imparted.

Bharat Gajjar, an enthusiastic participant, felt that clinical
pharmacy should replace dispensing pharmacy. UGs should be trained
in prescription writing based on P-drug concept, evaluating medicine
formulations available in the market, prescription audit, industry
medicine literature audit, pharmaco-vigilance for ADR, ADE
monitoring and reporting, and ethics in pharmacology.  Teaching from
disease to medicine should be encouraged in place of the current
practice of medicine to disease. More thrust should be given to
teaching RUM.

UGs should be taught in instructing patients; evaluation of
haematinic preparations, cough / cold remedies and antidiarrhoeal
formulations. They should be trained in problem based prescription
writing for common diseases with P drugs through GD. They should be
trained in prescription audit in outdoor and use it for self audit,
literature audit by evaluating promotional literature of
pharmaceutical  companies, pharmaco-vigilance for identifying,
monitoring and reporting  ADE / ADR. Ethics in practice of
pharmacology should be taught through case discussions.

Mira Desai, the seasoned Professor of Pharmacology feels that
current teaching is `medicine centered' and in clinical situation
students feel lost in selecting the medicines. The students do not
use their abilities of critical evaluation and can not correlate the
knowledge of pharmacology to clinical situation. They follow their
seniors or rely on the information of pharmaceutical companies,
which results into irrationality. UG curriculum should have training
in national health programmes and prevailing country health problems
and priorities.

Our present teaching is good in transferring knowledge but poor in
passing the skills and attitudes. Ideally there should be blend of
lectures + tutorial + problem based learning (PBL) + GD + project
work. The core idea of RUM, essential medicines can be taken in
lecture, application aspects of medicines can be taken in tutorial
and other related topics can be implemented in practicals. All
teaching / training must be evaluated in theory and practical
examination. When these become part of regular assessment, students
will definitely pay attention to the subject.

There should be practicals of 2hrs duration each on:
1. Selection of most appropriate medicine with its dosage
formulation considering efficacy, safety, suitability and cost.
2. Preparation of EML, emergency medicine list.
3. Evaluation of different sources of MI with their merits and
limitations.
4. Critical evaluation of medicine promotion literature based on WHO
guidelines.
5. ADR reporting - what, how, when and whom to report.
6. Pharmaco economics: cost analysis of medicines, difference
between brand and generics, direct and indirect price of medicines.
7. Evaluation of FDC - advantages and disadvantages.
8. Clinical application of antiseptic and disinfectants.
9. Communication skills - providing information and instructions to
the patient about the disease, dosage, ADRs through role play.
10. CCR exercises - Dictating / circulating notes for copying do not
serve any purpose. Exercises should be based on clinical problem
solving to initiate the thinking process and enable decision making.
UGs should be trained to mention about the non-medicine treatment.
They should know about other alternative drugs which can be
prescribed.

UGs should be given study projects on RUM like antimicrobial use,
self medication, prescription audit, prescribing behavior,
dispensing practices which should be part of journal work and they
should make presentations which will make the subject interesting,
enhance their communication and presentation skills. Poster
competition on RUM can be of interest and creative.

Integrated teaching should be arranged with medicine department for
common clinical conditions.

PROF. MIRA DESAI GOT THE BEST POSTING PRIZE FROM NETRUM.
-------------------------------------------------------------------

Mangesh Bankar, a young Lecturer in Pharmacology, felt that doctors
find it difficult to make a rational choice from the large number of
medicines available. They use medicines irrationally and in excess,
because they have never been systematically taught to do better.
Ineffective, unnecessary treatment is common, causing serious side
effects resulting in hospitalization. The UGs should be able to
refer existing national and international STGs, national formularies
and other sources of drug information.

There is strong need for improving pharmacotherapy teaching and
methods of teaching pharmacology must change. Teaching often remains
characterized by transferring knowledge about medicines, rather than
training students to rationally treat patients.
Rational prescribing involves a personal formulary of EM. Include
the teaching of P drugs to generate standard pharmacotherapeutic
approach to common disorders. They must develop a personal formulary
of medicines which they will use regularly. During career, doctors
are subject to many influences on their prescribing. Guide to good
prescribing makes students aware of these influences and helps them
to make optimal use of the information available in a rational way.

There are many irrational combinations available. It should be
taught during formative years so that they should be more logical in
selecting appropriate combinations and should not be swayed by
marketing tricks or false claims of the industry. The
pharmacological basis of combining each ingredient in the
formulation should be taught. Role play should be used to teach RUM
Narendra Bacchewar, a keen regular PG on NetRUM felt that in CCR
activity the students learn to identify the irrationality in
prescription and also correct the prescription and rewrite it for
the same indication. He felt that this is not paid much attention
and there is scope for improvement.

Chetna Desai, the energetic Associate Professor in Pharmacology,
felt that authentic source of MI and use of it contributes to RUM
and therefore should be part of the UG curriculum. RUM is forgotten
by the final year in the maze of irrationalities encountered and
confusion between what is taught in pharmacology and what is
practiced in clinics. Hence she supported the integrated effort in
teaching, need to train in RUM till internship with a compulsory
posting in pharmacology and hospital pharmacy. All PG courses and
specializations should have RUM in curriculum.

Well done members. We appreciate your inputs.
Keep networking.
Vijay Thawani
Moderator

Hello,

We know that ethics is an important but neglected issue in our
country.

When we talk about ethics related to drug development, we have
read many stories about unethical trials conducted in our country.
Interested reader may visit http://www.issuesinmedicalethics.org,
website of indian journal of medical ethics.

Clinicians study new drugs for various objectives — benefit
for patients, to contribute to advances in medical treatment, the
prestige of publication, financial benefits.

But now most aspects of trial from protocol, patient
recruitment rate to analysis of results are under control of
industry.

Also publication rights are also many times with them, all
these increases chances of unethical practices as only positive
results may be published.

Multicentric trials also published singly, trial site
investigators may not have any communication, laboratory standard
may not have followed.

There are also issues with herbal drugs, alternative medicine
trials as allopathic physician not trained/knowledge about active
ingredients.

There is need for ethics in medical practice also as
rational practice is many a times not observed, also associated with
corruption.

Another point in safety of patients in general is OTC drugs.
In our country almost all drugs are OTC. They are not always safe.
So Can't we have rules that OTC products having Improved patient
friendly labels?

As USFDA has given deadline for OTC manufacturers to print
active ingredients, Purpose, Use, Warning and Directions along with
inactive ingredients, I think we also should have such format, along
with necessary picture or local language use for more safer use of
OTC product.

I think i should stop now.

Thanks for patient reading!!

Wishing you good day.

Dr. Yashpal Jadeja
Pg student Pharmacology,
BJ Medical College,
Ahmedabad.

Hello all,
Her are some links you will definately find important for the
discussion on ethics and also for you examinations and further pharma
life

1) ICMR guide lines for clinical trials
www.icmr.nic.in/ethical.pdf

2)CPCSEA guidelines for Animal experimentations
medind.nic.in/ibi/t03/i4/ibit03i4p257.pdf

3)CDSCO shedule Y (most recent)
www.cdsco.nic.in/html/Schedule-Y%20(Amended%20Version-2005)%
20original.html

Regards
Dr. Narendra
GMC, Nagpur

HELLO NATRUMIANS,
               TAKING FORWARD THE DISCUSSION ON ETHICS IN DEVELOPMENT
OF MEDICINES,I WOULD LIKE TO ADD THAT THE NEED OF THE HOUR IS NOT TO
MAKE NEW LAWS TO SAFEGUARD THE RIGHTS AND SAFETY OF THE PARTICIPANTS
IN A TRIAL BUT TO IMPLEMENT THE EXISTING LAWS MORE STRINGINTLY.THE
PROBLEM WITH THE DEVELOPING COUNTRIES LIKE US IS THAT THE PUBLIC
MEMORY ABOUT THE ISSUES OF GREATER SOCIAL, HEALTH AND PUBLIC
INTEREST IS VERY SHORT.THIS HAS LED TO MALPRACTICE OF INTRODUCING
SIMILAR DRUGS WITH THE NEW PACKAGE AND COST STRUCTURE IN THE MARKET
IN THE NAME OF ADVANCEMENT IN MEDICAL FIELD AND THUS INCREASING THE
BULK OF THE LIST OF "ME TOO" DRUGS.BECAUSE OF THE FASCINATION
TOWARDS ANY NEWER DRUG IN THE MARKET,WE MEDICAL EXPERTS AS WELL AS
THE GENERAL PUBLIC START CONSUMING THEM BLINDLY AND THIS LEAD TO A
RAT RACE BETWEEN PHARMACEUTICAL COMPANIES TO DEVELOP MORE AND MORE
THE SO CALLED 'NEW'DRUGS AND THE ULTIMATE RESULT OF IT IS THAT THE
ETHICS THAT SHOULD BE FOLLOWED WHILE DEVELOPING NEWER MEDICINES ARE
SIDELINED FOR THE SELFISH MOTIVES OF FEW PHARMACEUTICAL GIANTS AT
THE SAKE OF HEALTH OF MAJORITY OF THE COUNTRYMEN.
             WE AS A HEALTH EXPERT ARE MORE RESPONSIBLE THAN THE
GENERAL PUBLIC TO KEEP A CHECK ON THIS TREND.ALL THE CLINICIANS
SHOULD HAVE A COMPULSORY RE CERTIFICATION SCHEDULE EVERY 5 YEARS OR
SO SO THAT THEY REMAIN UPDATED ABOUT THE LATEST DEVELOPMENTS IN
MEDICINE AND ARE ALSO ABLE TO JUDGE THE RATIONALITY OF THE USE OF
SUCH NEW DEVELOPMENTS.REGULATORY AUTHORITIES AS WELL AS
PHARMACEUTICAL COMPANIES SHOULD BE TRANSPARENT IN THEIR FUNCTIONING
AND BE MADE ACCOUNTABLE TO GENERAL PUBLIC.ABOVE ALL GENERAL PUBLIC
SHOULD BE VIGILANT ENOUGH TO SAFEGUARD THEIR RIGHTS AND TO OPPOSE
THEIR USE AS GUINEA PIGS FOR THE SAKE OF THE PROFIT OF SOME PEOPLE
IN THE TRIALS FOR DEVELOPMENT OF 'ME TOO' DRUGS

                                             Preetam Gandhi
                                             1st year resident,
                                             Pharmacology,
                                             BJMC,Ahmedabad

Hello, Mira ma'm and Vijay sir,

My views about ethics in medicine development are as follows,

As a resident I have seen my friends from Clinical sites being
offered various gifts and other generous incentives to get
prescriptions from the consultants.

only talking about the residents, Forget about the consultants.... I
have seen they being offered DVD players and tour to Singapore and
believe me this is true...

How can this be called as ethical promotion of medicines.

I have read about the norms that should be followed during drug
promotion, but they are far from reality... May be they should be
made slightly flexible as well (!!!!!!!!) to get nearer to the
reality!!!!!

Stringent control is needed for regulation of such activities but as
previously said in the discussion, WHO WILL BELL THE CAT?

And I believe ethics is something that comes from within, as Mira
ma'm had told us during a discussion.

Those who don't have it are definately influenced by it... I had
read an article in which it was said that in USA during a study 60%
prescriber were writing promoted drugs by their knowledge while 75%
were prescribing it for CONVENIENCE.

well, better said than done, so authorities should wake up in such
issues.

And I hope this is not too far from point of view of medicine
development as it is by this way pharma industry is developing
infrastructure for drug development...

Hello,

       We know that ethics is an important but neglected issue in our
country.

       When we talk about ethics related to drug development, we have
read many stories about unethical trials conducted in our country.
Interested reader may visit http://www.issuesinmedicalethics.org,
website of indian journal of medical ethics.

       Clinicians study new drugs for various objectives — benefit
for  patients, to contribute to advances in medical treatment, the
prestige of publication, financial benefits.

        But now most aspects of trial from protocol, patient
recruitment rate to analysis of results are under control of
industry.

        Also publication rights are also many times with them, all
these increases chances of unethical practices as only positive
results may be published.

        Multicentric trials also published singly, trial site
investigators may not have any communication, laboratory standard
may not have followed.

        There are also issues with herbal drugs, alternative medicine
trials as allopathic physician not trained/knowledge about active
ingredients.

         There is need for ethics in medical practice also as
rational practice is many a times not observed, also associated with
corruption.

         Another point in safety of patients in general is OTC drugs.
In our country almost all drugs are OTC. They are not always safe.
So Can't we have rules that OTC products having Improved patient
friendly labels?

         As USFDA has given deadline for OTC manufacturers to print
active ingredients, Purpose, Use, Warning and Directions along with
inactive ingredients, I think we also should have such format, along
with necessary picture or local language use for more safer use of
OTC product.

          I think i should stop now.

          Thanks for patient reading!!

          Wishing you good day.


Dr. Yashpal Jadeja
Pg student Pharmacology,
BJ Medical College,
Ahmedabad.

hello
as we enter in to medical field we face ethical issue
in every step beginning form the year of medical
science.
  as ethical issue in developing new drug is double
edged sward . first it unethical to do new drug
experiment in animals and second if we put ban on this
then development of science will be stop . so there
must be a in between solution for this
eg  as in certain medical college had dummy human body
on which intern doctor do practice of giving im iv and
other injection so it can avoid direct hazard to
patient in this way also  can develop the experimental
dummy on which we do drug trail .
also for animal handling we should follow the proper
guidelines and also there must be way in which animal
is sacrificed



________________________________________________________________________________\
____
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Dear Colleagues,
The producer as well as the prescriber of banned drugs are wicked.
The producer of bannable drugs are at best selfish.  The regulatory
agencies are wicked and/or inept and/or selfish.  However, one and
all need to evaluate what and where we get things wrong, i make bold
to say regulatory agencies, the manufacturers, the prescribers and
even the consumers are ALL guilty!  There are cases of patients
despite knowledge of ban on a particular drug insisting that it is
the same drug that they will take!  Of course in a number of countries
  particularly the developing ones, ALL drugs are OTC!!! I think
regulatory agencies need to be more alive to their responsibilities
by conducting independent studies and not just simply rely on reports
from abroad since 'seing is believing!'  The governments should also
be alive to their responsiblities by providing necessary fund and
avoiding interference in the activities of these agencies.
Consumers, manufacturers need a lot of education and re-orientation.
The prescribers must undergo compulsory re-certification and there
must be appropriate sanctions.
Finally, let me appreciate my friend and superior, Professor Vijay
Thawani for providing this opportunity.  I should also appreciate all
the other 'RATIONALISTS' too!
Chhers,
Dr Fatai Fehintola
Department of Clinical Pharmacology
University College Hospital,
Ibadan, Nigeria
In netrum@yahoogroups.com, "Vijay" <drvijaythawani@...> wrote:
>
> Hi
>
> We all are aware that the condition of the health industry is not
> healthy. The industry and regulator are responsible for the
> irrational production and permission to sell the rotten junk in the
> name of medicines. Do read the book published by Voluntary Health
> Association of India on "Banned and bannable drugs".It is indeed
> sorry state of affairs of The State, that inspite of pointing that
> the bannable medicines should not be produced, all look the
> otherside.Times of India rightfully called them Friends of Drug
> Adultrators.
>
> Look at what is happening in case of Nimesulide. Some 40 odd
private
> practioners under the banner of "dettol" association (pun intended)
> vouched it to be safe! When the worldover the said medicine is
> banned we approve it as nice! And our industry does the dis-service
> of even producing pediatric preparations for same. Ask the pharma
> company directors manufacturing such bannable products whether they
> administer these to their children?
>
> Who will bell the cat? We, who else? Such fora are meant for taking
> a stand. Be proud that we are talking in the best interest of
> humanity. I expect Netrumians to stand for the cause and be
counted.
> Discussion and then submission of the summary to the concerned
carry
> the message that the populations have started objecting to the
> apathy, callousness and indifference. So the notice will be taken
> and remedial measures introduced. If we dont speak than who does?
We
> are the catalysts of change and must spread the word about
> rationality in medicines.
>
> Vijay
>

Hi

We all are aware that the condition of the health industry is not
healthy. The industry and regulator are responsible for the
irrational production and permission to sell the rotten junk in the
name of medicines. Do read the book published by Voluntary Health
Association of India on "Banned and bannable drugs".It is indeed
sorry state of affairs of The State, that inspite of pointing that
the bannable medicines should not be produced, all look the
otherside.Times of India rightfully called them Friends of Drug
Adultrators.

Look at what is happening in case of Nimesulide. Some 40 odd private
practioners under the banner of "dettol" association (pun intended)
vouched it to be safe! When the worldover the said medicine is
banned we approve it as nice! And our industry does the dis-service
of even producing pediatric preparations for same. Ask the pharma
company directors manufacturing such bannable products whether they
administer these to their children?

Who will bell the cat? We, who else? Such fora are meant for taking
a stand. Be proud that we are talking in the best interest of
humanity. I expect Netrumians to stand for the cause and be counted.
Discussion and then submission of the summary to the concerned carry
the message that the populations have started objecting to the
apathy, callousness and indifference. So the notice will be taken
and remedial measures introduced. If we dont speak than who does? We
are the catalysts of change and must spread the word about
rationality in medicines.

Vijay

Netrumians, What I feel about medical ethics is that they are a preformed rules guiding our practice, like Schedule Y, CPSCEA, ethics on organ donation....etc.

               Changes can only be made after varoius discussions or suggestions which get approved and new Acts formed.

                       Anupama.

---

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Hello all,
In my last post I paused at the two pillars of ethics i. e. " IEC"
and 'protocol'

Ethics comittee can be institutional or extra-institutional. Both
Shedule Y and ICMR provide guidelines for smooth functioning of IEC.
In general the composition is
1] One chairperson- He should be from out of institute.
2] 1-2 medical scientists
3] 1-2 senior clinicians
4] One legal expert- Commonly he is a retired Judge
5] one social scientist ( a nonmedical scientist)
6] One philosopher
7] one lay person
8] one secretory- commonly a person from Pharmacology department,who
co-ordinates with other people.
      thus maximum 15 members are allowed.

Protocol should have following in general....
1] Aims and objectives
2] Inclusion and exclusion criteria
3] Study design.
4] Curriculum vitae of all investigators
5] Indicators of stopping a trial.
6] Statistical analysis method.
7] Procedure for consent
8] Safety data of Proposed intervention.
9] Proposed compensation/reimbursment.
10] Data processing methods.
11] Plans on publishing results.
12] Aggrement to comply with GCP rules.
13] Details of funding agency & conflict of interest.
14] Written informed consent form proforma.( The most Important)

i think this much of basic is suffucient to start this discussion.
I am open for corrections.

Regards
Dr. Narendra
GMC, Nagpur

Dear Netrumians,

Hello !!

 

After a break , lets gear up for the discussion on next topic..........

'' Ethical issues in medicine development" which will be open  from 18th - 28th Nov.2006.

Medicine development is a highly technical, time consuming and expensive process involving animal studies and clinical trials.Animal rights activists protest to the use of animals which has become a major concern.It is also a fact that India has become a major hub for the  clinical trials.In spite of code of ethics, reports of unethical practices keep coming.Pharmacologists are involved in the medicine research, animal studies and clinical trials.

Further,lot of interest and enthusiasm has been observed in topics of clinical research among our members from the  previous discussion.Hence, it is felt that we should discuss "Ethical issues in medicine development" on NetRUM.

It is my privilege to moderate .We look forward to your active participation and valuable inputs.

Best inputs will fetch the participant a certificate /memento/ both from NetRUM.
So happy posting and best luck.

 

Dr Mira Desai
B.J.Medical College,Ahmedabad.
Moderator

---

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Send FREE SMS to your friend's mobile from Yahoo! Messenger Version 8. Get it NOW

Hi
Honoured to have Pof Mira Desai as moderator on NetRUM.

Here are some areas which need discussion in the ethical issues in
medicine development:

1. New medicine development for prevalent diseases in the country
and National health programmes.
2. Are new medicines needed for the diseases where the market is
flooded with too many "me too" medicines?
3. Medicines for orphan diseases and availability of financial
subsidies for their development.
4. Participant enrolment, trial information and consent in clinical
trials.
5. Conflict of interest in clinicals.
6. What should be the capping on the margins of profit in the sales
chain for new medicines?
7. When should the new medicines be allowed to be sold in Indian
market for the special groups like children, geriatric population?

I am starving to see the topic picking up.
Vijay

--- In netrum@yahoogroups.com, Mira Desai <desaimirak@...> wrote:
>
> Dear Netrumians,
>   Hello !!
>
>   After a break , lets gear up for the discussion on next
topic..........
>   '' Ethical issues in medicine development" which will be open
from 18th - 28th Nov.2006.
>
>
> Medicine development is a highly technical, time consuming and
expensive process involving animal studies and clinical
trials.Animal rights activists protest to the use of animals which
has become a major concern.It is also a fact that India has become a
major hub for the  clinical trials.In spite of code of ethics,
reports of unethical practices keep coming.Pharmacologists are
involved in the medicine research, animal studies and clinical
trials.
>   Further,lot of interest and enthusiasm has been observed in
topics of clinical research among our members from the  previous
discussion.Hence, it is felt that we should discuss "Ethical issues
in medicine development" on NetRUM.
>
> It is my privilege to moderate .We look forward to your active
participation and valuable inputs.
>   Best inputs will fetch the participant a certificate /memento/
both from NetRUM.
> So happy posting and best luck.
>
>   Dr Mira Desai
> B.J.Medical College,Ahmedabad.
> Moderator
>
>
>
>
> ---------------------------------
>  Find out what India is talking about on  - Yahoo! Answers India
>  Send FREE SMS to your friend's mobile from Yahoo! Messenger
Version 8. Get it NOW
>

Hi Netrumians

Fill the tanks with knowledge based input, rev up the engines to get started with zeal, for the discussion on the new topic " Ethical Issues in Medicine Development " from 20  to 30 Nov 2006. The discussion will be moderated by ever enthusiastic medical teacher, gentle and caring KAP builder, Professor Dr Mira Desai of BJ Medical College, Ahemedabad.

Dr Mira Desai to kindly take over the discussion on the topic. We welome you madam with from NetRUM

Vijay

Group Owner

 

 

Hi Netrumians

Fill the tanks with knowledge based input, rev up the engines to get started with zeal, for the discussion on the new topic " Ethical Issues in Medicine Development " from 20  to 30 Nov 2006. The discussion will be moderated by ever enthusiastic medical teacher, gentle and caring KAP builder, Professor Dr Mira Desai of BJ Medical College, Ahemedabad.

Dr Mira Desai to kindly take over the discussion on the topic. We welome you madam with from NetRUM

Vijay

Group Owner