Intended for healthcare professionals

Rapid response to:

Analysis Health Systems Perspectives

Raising the bar for market authorisation of new drugs

BMJ 2012; 345 doi: https://doi.org/10.1136/bmj.e4261 (Published 07 August 2012) Cite this as: BMJ 2012;345:e4261

Rapid Response:

Re: Raising the bar for market authorisation of new drugs

A study conducted by the Bristol-Myers company to predict medical advance reveals that during 1986 the rate of cancer cure was about 50% but it is around 65% during 2002. Streptokinase was drug of choice in MI with risk of thrombolysis but now advancement in technology has increased the rate of survival. It has been found that we can produce the artificial genome and can regenerate nerve cells by using genetic engineering1. But at the same time Oxfam report says that the pharma industry is not interested in delivering its services to developing countries2.

The amount spent on health care research has tripled since last two decades (Data till 2010). Its large share is from drug industries. Health care research requires more funding also, as health is one among the basic needs of a human being and no question arises if it's to be more transparent and reaches those who are needy.

At the same time Cyert and March’s Behavior theory of Firm says that a firm is a unit having multi-goal, multi-decision, multi-product. If we just look towards the amount required to invent a new drug molecule, it takes around seven years and costs approximately $282 million, which can be reduced to more than 50% by conducting the same research in developing countries like India3 and mainly countries from Africa--i.e, as Rudolph Virchow said, “Medicine is a social science and politics is nothing but medicine on a large scale".

It is quite a common assumption that Government is paying for basic research and the corporate sector for applied research4. This can be altered slightly by imposing taxes on people from developed countries like US and Japan which should be used for applied research. And at the same time corporate sector, one that enjoys more Producers Surplus, must be involved in conducting Research in basic sciences like genetics, biochemistry, etc, and put more emphasis on education. For instance, Bill and Melinda Gates funding $100,000 each for 78 innovative projects which may help Society in future, and Venus Remedies working along with Punjab University to develop Typhoid Detection kit, as Typhoid claims nearly 6,00,000 deaths annually around the world.

Dr Prathap Reddy of APOLLO Health Care Group, India, says: “Innovation and a superior patient experience are the two aspects of our business model”. While experts say, countries must prepare for self sufficiency in their health care system. Developed countries as well as WHO, are giving more importance to providing health care to those who are unable to afford it. Paying for research, education, and control over drug prices costs much more than production costs, Dr Mansfield said.

In conclusion, there is no wrong if any corporate company conducts or sponsors a CME to advertise or to share their development in R & D, but it is left to the medical community to decide what is wrong and right and also to decide what is their role and contribution to the society. Why? Because Medical fraternity is not immature and unaware about ethics of practice; Hippocratic oath says, "I will prescribe regimens for the good of my patients according to my ability and my judgment and never do harm to anyone" before doctors start their practice. Ultimately it left to the doctors' community to encourage moral practice. and pharmaceutical companies must decide how to use Producers Surplus as bribe or to share with scientific community for Humanitarian causes.

References.
01.Rob Stepney, Back to the future: how good are doctors at gazing in the crystal ball? BMJ 2006;333:1311-1313
02. Adrian O'Dowd, Drug companies are ignoring health crisis in poor countries, Oxfam says., BMJ 2007;335:1111
03.Brazier, Nicole C.; Levine, Mitchell A.H. Drug-Herb Interaction Among Commonly Used Conventional Medicines: A Compendium for Health Care Professionals, American J The, May/June 2003 - Volume 10 - Issue 3 - pp 163-169.
04. Melissa Sweet , Doctors and drug companies are locked in "vicious circle" BMJ 2004;329:998

Competing interests: No competing interests

10 September 2012
Kamath Madhusudhana
Asst Prof
KMC
KMC,MANIPAL UNIVERSITY,MANIPAL 576 104