The U.S. FDA classified three-fourths of the 119 drugs it approved last year as similar to existing ones in chemical makeup or therapeutic value. UNDP reports that less than 5% of drugs introduced by industry in USA are true innovations and these too have developed with Government involvement. A study published in Lancet shows that 68% drugs marketed in the past 25 years are me too drugs. Surprisingly even the so-called qualified and informed prescribers fall for this ploy. Often when the patent of a drug is to expire, the company is ready with its "me too"!

The FDA approves drugs on the basis of their superiority to placebo, not their superiority to existing drugs. This gives a lot of leniency to me too drugs.

Any solution to this? Maybe. First consumers need to be educated. Second the regulators need to be choosier in approving drugs. Free public sharing of newer innovations also helps. We also need to realize that me too drugs come at a sacrifice…a sacrifice of innovation and better ideas in drug development.

More in next post

Chetna Desai

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
>
>
>
>
> ---------------------------------
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