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The business of ethical drugs is part of a vast and extraordinarily complex industry that has evolved from the unregulated patent medicine makers of the nineteenth century whose advertisements were ubiquitous in the popular press and who encouraged the sick to write to them for advice about their medical problems
Slowly, under the auspices of the American Medical Association, rules were established to prevent false claims in advertising and to force the companies to choose their market – either doctors or laymen. As public opinion shifted, medicine companies became deferential to doctors; they realized that it was not possible to “make every man his own physician”. Little by little, the voice of scientific medicine came to be heard.
Thus, for more than one hundred years the pharmaceutical industry has been seeking its ideal business model. If it has failed to do so, it is not for lack of trying and experimenting. Careful reading of its history for the past century, especially in its inordinately complex relationship to its customers – patients, doctors, insurance companies, benefits managers, and regulators – can only result in the conclusion that the more it changes the more it remains the same. This is not necessarily a bad thing, for at its best, the industry requires a creative mind-set and nimbleness of action.
That said, it is incumbent upon the industry to recognize that it is like none other, in its social responsibility and the incumbent scrutiny that is so generated. The pharmaceutical industry must now once again decide what/who it is and what it wants to be. This Plenary Session will explore this crisis of identity in the industry from the point of view of the pressures it is currently experiencing.
We would suggest that the industry is best positioned to do so itself and not to be driven exclusively by quarterly reports and Wall Street Analysts. As it looks to the future, it should look to the past – keep the good, the tried and tested and chuck out the bad. It should remember, for example, it took forty years from the discovery of the Philadelphia Chromosome to the creation of a new therapeutic modality for chronic myelogenous leukemia.
There is no doubt that the industry has accomplished remarkable advances in therapeutics and continues to do so. There are now unique pressures that have come about through extraordinary advances in the scientific understanding of disease and the burgeoning of genomics and proteomics. Perhaps also, all the “easy” diseases have been, if not beaten, been put in retreat. Then too, the growth of the venture capital industry and its funding of huge numbers of early stage and highly focused biomedical and biotechnology companies has stolen the march on the less nimble mega pharmaceutical houses.
The continuum of the inspired, brilliant and optimistic minds of medicine is long and amazing: Aristotle, Galen, al-Rhazi, Avicenna and on to Harvey, Morgagni, Jenner, Koch, Ehrlich and the innumerable doctors of the modern era. All had a place to work (although Jenners was most modest and he was self-funded). The Academies in ancient Greece and Royal Courts in the Caliphates of Damascus and Alexandria gave way to universities and institutes, which then became the venues of the most important medical discoveries.
It was only in the nineteenth century that industry became a place for medical research. Even later on, national institutes for healthcare research appeared in Europe and in the Western hemisphere. These were publicly funded centers that promoted both basic and applied research.
What will be the major shift of the 21st century and why? Will basic research continue at the same pace as during the 20th century?
Universities pay for faculty and their research by a variety of means: government grants, private philanthropy, industrial partnerships and venture capital. At the same time, technology transfer offices have been established at prestigious universities that saw and seized the opportunity to make money for almosenary pursuits. Academics have generally thought it a good thing to see their discoveries commercialized and they themselves are at last able to supplement their meager remuneration.
While this has worked well for the microelectronics industry, the history in healthcare and biotechnology is different, for the time horizons must be longer and, even after brilliant discoveries, failure to commercialize may occur years and years after the innovation itself.
Given the current climate, how can universities continue to attract corporate
partners and attract them for the longterm?
This was the concluding round table of GMF III and will per force be a synthesis of what is known scientifically, medically, technologically, socially and economically about diseases and patients, how to treat them and make them better. Disease State Management is not a new concept. It came to the fore when people began to feel, either rightly or wrongly, that the health maintenance and managed care organizations were driven by one goal only: to make money and to be rewarded by not providing care.
Disease State Management is not an alias for HMO’s. It should be driven only by outcomes and by quality. Any experienced healthcare professional knows that the cost of healthcare is driven up by complications and in the greater scheme of things the best care is the most cost-effective care, provided society has made the decision to care.
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GMF | 2.0
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