Applied Clinical Trials
Daniel Callahan (University of California Press, Berkeley, CA, 2003), 341 pages, hardcover, ISBN: 0-520-22771-9. $29.95.
What Price Better Health? Hazards of the Research Imperative
Daniel Callahan (University of California Press, Berkeley, CA, 2003), 341 pages, hardcover, ISBN: 0-520-22771-9. $29.95.
Daniel Callahan, a Hastings Center and Harvard ethicist, writes about the research imperative which holds that there is a pervasive felt drive to use research to gain knowledge for its own sake, or as a motive to achieve a worthy practical end.
In its expanded form, Callahan writes that the research imperative leads to rationale for pursuing research goals that are of doubtful human value or are potentially harmful. It also serves as a public relations tool to justify the pursuit of profits for the pharmaceutical industry and to compromising important moral and social values. His writings take direct aim at drug and biotech studies.
Callahans ideal research would be safe, socially beneficial, resistant to market determinations, conducive to sustainable and affordable drugs, conducive to equitable access to health care, open to meaningful public participation in setting priorities, morally acceptable to the public, sensitive to moral views held by the public, and consistent with the highest human good and human rights.
He claims that the research imperative is a cultural problem and not a problem caused by evil researchers, narrow, self-absorbed intent groups, or a benighted public. He wants to hold the pharmaceutical industry to a differentand highermoral standard than other industries because of its participation in public health, and he is highly suspicious of the industrys traditionally high profits.
Callahan believes that the high cost of health care is the direct and indirect result of a combination of profit-greedy drug companies, their expensive drugs, and their inappropriate research targets. Because he is not a health economist, health systems analyst, or epidemiologist, he struggles to back up these claims. He then goes on to state that the pharmaceutical industry has as great an obligation to those whose drugs it serves as to its stockholders. In other words, he would like drug manufacturers to behave more like NIH and nonprofit educational institutions and less like Nextel.
Callahan wants low-cost blockbusters and universal health care. This book is a thinly disguised argument for reducing what Callahan terms the excessive play of the market, both its growing force in research and its already strong place in health care.
The author is on more solid ground when he discusses the ethics of modifying life processes, the protection of human subjects, informed consent, use of vulnerable subjects, and research in developing countries. Here the writing is better researched, and the ethical arguments have more validity.
The book has an extensive bibliography with citations from sources previously unknown to this reviewer.
Douglas R. Mackintosh, DrPH, MBA, MSHyg, is president of GCPA, Inc., Fairfax Station, VA.
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
Zerlasiran Achieves Significant Sustained Reduction in Lipoprotein(a) Levels with Infrequent Dosing
November 20th 2024Zerlasiran, a novel siRNA therapy, demonstrated over 80% sustained reductions in lipoprotein(a) levels with infrequent dosing in the Phase II ALPACAR-360 trial, highlighting its potential as a safe and effective treatment for patients at high risk of cardiovascular disease.