|Editor's Note: The views expressed herein are those of Dr. Triggle in his capacity as a private citizen and do not reflect official positions of SUNY-Buffalo, Pharmaceutical Manufacturing magazine and PharmaManufacturing.com, or Putman Media. We offer this piece as a springboard for discussion among those in the pharmaceutical community. We invite you to respond via e-mail to [email protected] or take the poll below (anonymously).
The 16th-century physician Theophrastus Philippus Aureolus Bombastus von Hohenheim, better known as Paracelus, knew well what the public and politicians of today choose not to: All things are poison and nothing is without poison: only the dose makes a thing that is not poison.
This contemporary public ignorance should not surprise us: significant fractions of the American public believe that we are regularly visited by extraterrestrials, accept ghosts and extrasensory perception (ESP), do not believe in evolution and have faith that the earth and its inhabitants were created in their present form some 6,000 years ago.
By itself, this nonsense is pretty harmless: After all, believing that the earth is flat probably does little more than restrict ones travel choices.
However, a lack of understanding of science and the scientific method translates into an inability to deal with those issues where scientific input is vital. Many of these issues are health-related: stem cells, reproductive technologies, cloning, the distribution of health care in the rich and poor worlds, the generation and provision of medicines and vaccines, and the evaluation of their safety and efficacy.
All of these issues, including the use of medicines and vaccines, require an evaluation of risks and benefits through informed, science-based decision-making.
Absent scientific understanding, this cannot occur. Hence, the general inability of the public to make informed decisions about medicine use or to accept that absolute safety is an impossible goal.
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Too frequently this is not the case, as in the ongoing national debates around evolution, stem cells, GM foods, global warming and energy. In these and other instances, science is either ignored or replaced by ideologically based arguments.
This is also the case with decisions around medicines.
The transparently ideological basis of the decision-making process around the post-coital contraceptive Plan B is but one instance.
After several years of stalling approval, the FDA announces on the eve of Acting Director von Eschenbachs Senate confirmation hearing that a decision may soon occur!!
How can the public have confidence in such a process or in the individuals involved?
Similarly, the approval of the vaccine Gardasil, effective against the human papilloma virus (HPV), the cause of the second most common female cancer, was challenged by a number of fundamentalist religious groups who, even after FDA approval, continue to work to dilute its availability. Their principles dictate apparently that they would rather have their daughters die of cervical cancer (and for the parents principles), than accept that she might have a sexual encounter you have to wonder what sort of religion would countenance this immoral nonsense. Focus on the Family, one of the largest of such groups, argues that mandatory HPV vaccinations would be the ways things are done in dictatorships, not democracies.
Indeed, it may be argued that the entire decision-making process around the approval and availability of medicines has been rendered suspect from a variety of perspectives, and not simply from crackpot religious ideology.
Pharmaceutical companies claim the primacy of their intellectual property rights over medical needs in the poor world, their marketing arms invent new diseases or exaggerate existing disorders to increase drug sales, direct-to-consumer advertising increases the pill-for-every-ill syndrome (including well-known killer diseases such as toenail fungus and the not tonight, dear disorder of female sexual dysfunction), and the companies fight against the transparency of clinical trial reporting.
Nor are these conflicts in decision-making confined solely to industrial organizations.
A very recent survey of FDA scientists by the Union of Concerned Scientists documents a serious level of administrative interference in scientific decision-making.
The latest report from the Center for Science in the Public Interest indicates that almost 20% of the scientists appointed to National Academy of Sciences advisory panels have financial ties to companies with an interest in the outcome of the study. Similar and larger conflicts have been reported for FDA advisory panels. Medical journals have come under scrutiny both within and without for failures to document financial conflicts of interest of their authors and for the advertisements that they carry. As Upton Sinclair once noted, It is difficult to get a man to understand something when his salary depends upon his not understanding it.
Medical journal editors have been dismissed, most recently at the Canadian Medical Association Journal, for publishing material deemed inappropriate by the journal owners.
And conflicts between universities and industrial sponsors of research over the rights to publish material that may be unfavorable to corporate interest are well documented, and inevitable as universities strive to assume corporate profit-making characteristics. Finally, the integrity of academic scientists is also under challenge, most recently from the fraudulent stem-cell research of Korean scientist Woo Suk Hwang, but also from a 2005 survey by Nature indicating that more than a third of participants acknowledged that they had been involved in or knew of unethical conduct. Some have suggested that there is a global trend of more science, more fraud.
Because of these conflicts, the consumer of medicines is in the unenviable position of not being able to arrive at informed decisions easily or to make the appropriate risk/benefit analysis.
Nor, for that matter, can the relevant regulatory agencies, for they too will increasingly lack the necessary transparent and objective data. The FDA has had a permanent director for only 18 months of the entire Bush presidency, consistent with the unimportance of regulatory agencies in the current political climate.
None of this should be surprising. Adam Smith knew it well: People of the same trade seldom meet together, even for merriment and diversion, but the conversation ends in a conspiracy against the public.
These two-centuries-old words resonate in todays neo-liberal environment dominated by the assumption that the market reigns supreme and that human well-being can only be advanced under the banner of private property, free markets and free trade rights, and that the role of the state is solely to maximize these rights by ensuring that regulatory restrictions are abolished or minimized.
In the words of Karl Polanyi, Planning and control are being attacked as a denial of freedom . . . and the freedom that regulation creates is denounced as unfreedom.
There are harsh words in this opinion piece. In my opinion, necessarily so.
Carl Sagan famously observed: "It is suicidal to have a society dependent on science and technology in which hardly anybody knows anything about science and technology.
It is equally suicidal to permit the observations and lessons from science to be overridden by political and religious ideology, and personal and corporate greed.
About the Author
David J. Triggle, Ph.D., is a SUNY Distinguished Professor at the State University of New York (SUNY) at Buffalo and president of the Center for Inquiry Institute. He may be reached at [email protected].