Day Two Afternoon: Tuesday, 5 April 2005

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Plenary session: The search for new medicines: A new model?

In the mid-nineteenth century, the Bohemian Monk, Gregor Mendel, working in an Augustinian Cloister in Brünn, demonstrated in edible peas the segregation and factorial inheritance of single characteristics– information passed from parent to offspring from a repository of heritable information. On 26 June 2000 President Clinton and Prime Minister Blair announced, in the presence of Craig Venter and Francis Collins, that the human genome had been deciphered and that a new age in biology and medicine had been entered. Did this mean, as Professor Wallace Gilbert of Harvard suggested, that biology’s quest for the «holy grail» had been attained?

A shared question was whether or not these molecular treasures would be formulated into life-prolonging medicines by academe and the pharmaceutical and biotechnology industries. From the beginning it was clear that DNA sequencing would spew out massive amounts of information and that the challenge lay in deciphering what molecules in the three billion letter sequence of life were important to understanding the nature of man’s being and identity, the molecular language of life and the causal factors in human disease.

There are at least two answers to the resulting question «Is the research revolution a myth?» One is negative and one is positive. It goes without saying that the complex relationship between the human genome, cell biology and disease will take time. The fact that Dolly and her flock are dead, are no deterrent to believing that a new «golden age» of medical science are here. The fact that to translate that science into money-spinning cures for major diseases such as Gleevec and Herceptin has taken decades should not be a cause for pessimism. Nor should the fact that human beings possess far fewer genes than the most complex organisms or the recent discovery that identical sequences of junk DNA exist in humans, mice, and rats.

In this new, post-genome, age of information technology, we must ask how new therapeutic agents will be discovered? Will clinical observation at the patient’s bedside play any role in either stimulating new discoveries or in pointing the way to a new frontier? What will be the roles of researchers from universities, from the giant pharmaceutical companies, and from the ever-promising biotechnology industry? Will marketing and trial regulation interfere with this process? This plenary session will address some of these issues and give an overview of where on the road to fulfillment is the 100 year old dream of Paul Ehrlich for the magic bullet – the exquisitely targeted, non-toxic chemotherapeutic agent.

Round Table 1: Proposals on global pharma pricing

In real terms the annual research and development expenditures by major pharmaceutical companies has increased tenfold since the early 1980s, to more than $ 30 billion. But the flow of new drugs winning regulatory approval has remained essentially static.

At the same time, society only marginally faults the automobile industry for using the basic technology of the internal combustion engine for the past century. Why then has Western society come to expect a steady flow of new and sophisticated therapeutic agents at static cost levels? This Round Table will seek to propose ways in which the pricing of pharma products can be better linked to their development cost.

Much of the research funding that contributes to cost flows as follows: from government to university to start-up biotech company to major pharmaceutical company or IPO. All along the way to clinical success the risks are enormous and investors can suffer losses. Is it still then justified for investment analysts to apply the same rules to evaluate success in software as in pharmaceutical and biotechnology industries? Are these rules applied because of a misunderstanding in the true cost of new agents? Can these questions serve as the basis and rationale for governing pricing and business practices in life science companies?

Round Table 2: The physician as agent of change: How can society train its physicians to see the nexus of medicine and the society’s resources?

In 1988, The Johns Hopkins University Press published a book entitled «The New Medical Marketplace: A Physician’s Guide to the Health Care Revolution.» In the prologue John Gordon Freymann, M.D., President Emeritus of the National Fund for Medical Education wrote the following: «Once upon a time, the American health care system flourished in a fool’s paradise of cost-plus reimbursement and bottomless budgets. No wonder considerations of cost never sullied medical education.» The position of the physician within the healthcare ecosystem has changed dramatically, largely by default and has left practitioners surprised, bewildered, anxious, unhappy, frustrated, resentful and dissatisfied. In many ways the commercial climate of medicine has superceded the traditional professional values of placing first the interests of patients. Lamentably, medical students and physicians are given too little education to understand what is happening and why. To fulfill their unique oath it is apparent that physicians must now become involved in the rough world of the healthcare marketplace. How can the medical educational system implement this necessary shift?