At a recent conference on spinal cord injury (SCI), a scientist challenged me because I’d written about therapies that had yet to be vetted by the rigorous standards of objective science. It was as if he’d appointed himself sheriff, and deputized his colleagues. As someone who’s been involved in the scientific process for decades—at times at the national policymaking level—I thought his ‘science as sacred cow’ attitude was not only naïve, but also a roadblock to progress.
Although an invaluable signpost guiding us to new discoveries, the scientific process is—from the basicscience laboratory to real-world clinical practice— inherently subjective. The more we ignore this fundamental truth, the less effective we will be in developing real-world treatments for a multitude of conditions.
DOUBLE BLIND OR DOUBLE STANDARD
In his advocacy of high scientific standards, the aforementioned scientist apparently was unaware that most routine medical practices do not meet such criteria. Specifically, the Congressional Office of Technology Assessment (as well as others) concluded that only about 10 percent to 20 percent of such practices have been scientifically proven. Most have been grandfathered in, getting what you might call a “free pass,” because “we’ve always done it this way.” By contrast, muchneeded innovative therapies face huge regulatory hurdles. In the case of SCI, for instance, which has a relatively limited economic market, making scientists jump through hoops will ensure that development of new therapies will continue to evolve at a snail-pace.
This double-standard hypocrisy is systemic in biomedicine. For example, at the conference mentioned earlier, a U.S. scientist was highly critical of an innovative— albeit questionable—function-restoring therapy being developed in China. He found fault with it primarily because it had been made available to the public without sufficient testing. But one of the field’s foremost scientists later noted that this critic routinely performs surgical procedures that lack the testing he purports to demand of his Chinese colleague.
LESSONS OF HISTORY
If we learn anything from history—such as the persecution of Galileo for proving that the Earth moves around the sun, or the ridicule of Ignaz Semmelweis. for audaciously suggesting that physicians wash their hands—it is that today’s righteously defended scientific beliefs will be tomorrow’s anachronisms. The only factor that distinguishes present scientific truths from those of the past, again, is subjective judgment.
Early in my scientific career, I had the good fortune to meet several of the modern age’s titans of science. Their breakthrough discoveries show just how relatively subjective science can be. For example, when I was a fledging biochemist, I met Sir Hans Krebs, who was awarded the 1953 Nobel Prize for exposing the metabolic pathways that are now at the foundation of medicine. But before the accolades, he faced the naysayers—as emonstrated when he showed my colleagues and me a letter that he had received from the prestigious journal, Nature, which had declined to publish his seminal work because they said that it had insufficient scientific merit.
Today, as I write about therapies that challenge the status-quo, I often reflect on Krebs’ rejection letter. If the father of modern biomedicine could be turned down by a prestigious scientific publication, what innovative therapies are experts rejecting today, based on subjective, limited views of the world?
“Every man takes the limits of his own vision for the limits of the world.” —19th century German philosopher Arthur Schopenhauer.
Around the same time I met Krebs, I made the acquaintance of Dr. Francis Crick, winner of a 1962 Nobel Prize for elucidating the structure of DNA, the molecule at the core of life. Later, Crick acknowledged that he perceived the double-helix structure of DNA while under the influence of LSD. It is “mind-blowing” to know that this revelation occurred while he was in a drug-induced state of consciousness.
INTUITIVE VS. OBJECTIVE SCIENCE
Science is not supposed to work this way; it has welldefined procedural rules. Nevertheless, intuitive insights, whether they are triggered by dreams, meditations, out-of-the-blue epiphanies, etc., play a much larger role than is commonly acknowledged.
One of history’s better-known examples is German chemist Dr. August Kekule 19th century discovery of the structure of benzene. His breakthrough came during a hypernagogic state, after he dozed off in an easy chair in front of his fireplace. Most scientists fear that they’d be ridiculed by colleagues if they were to admit that a breakthrough was inspired through non-traditional means.
This observation does not suggest that science should lack rigor. As Louis Pasteur said: “In the fields of observation, chance favors only the prepared mind.” Yet over time, the best scientists have learned how to integrate the intuitive with the objective—the yin with the yang. For example, Crick was an exceedingly welltrained scientist whose insights, during a state of altered consciousness, synergistically complemented his discipline.
In a rough analogy, the difference between playing by the scientific rules and a more expansive, creative process is like the computer playing chess against the strategically insightful grandmaster. The computerlike scientist has to go through a lot of experimental iterations to make progress, but lacks the computer’s speed. Unencumbered with the blinders of the scientific process, the “grandmaster” has a more expanded vision of what is possible, can bypass procedural steps viewed as unnecessary, and, in turn, make a quantum-leap forward.
Native American philosophy reveals useful insights. Specifically, in 1995’s The Way of the Scout author Tom Brown, Jr. describes how, when he was a child, an Apache elder taught him to use an “expanded focus,” where the task or objective is but a small part of a bigger picture. When we relax our absolute focus (i.e., the scientific process), we become more aware of life’s flow around us, and gain access to unanticipated assistance or insights.
Similarly, scientists who restrict themselves to sanctioned formulas are essentially no more than super technicians. By contrast, those who subordinate the scientific process to their creative, expansive insights tap a vast experimental palette.
SUBJECTIVITY AT THE NATIONAL INSTITUTES OF HEALTH (NIH)
With a $29-billion budget, the NIH is the world’s most prestigious and powerful biomedical agency. Through a complicated grant-application process, the agency funds most of the biomedical research carried out at our nation’s hospitals, universities and research institutions. When it comes to setting the nation’s biomedical agenda, NIH is the 800-pound gorilla. Although the agency’s public health contributions have been immense, its decision-making is influenced by a host of factors and agendas that go beyond strict objective science.
In 2006, the NIH received approximately 46,000 grant applications seeking funds that greatly exceeded the organization’s budget. At some institutes, for example, administrators funded only 10 percent of applications received. A multitude of NIH committees of expert scientists sort applications by merit and assign priority scores. Unfortunately, even some highly meritorious applications cannot be funded.
I was in charge of this process at one of the NIH institutes, where I managed peer review of thousands of applications and witnessed, first hand, that the priorities of the teams is greatly influenced by the team’s composition, character, and overall dynamics, which reflect the highly subjective viewpoints and priorities of individual members. For example, if I was going to review clinical trial applications, I could recruit a team composed of scientists that emphasized study design (e.g., biostatisticians, epidemiologists, etc), or I could lean towards clinicians with more hands-on appreciation of the issues being studied. Each group would have very different beliefs based on what issues were important to them, and thus the proposal ranking would vary greatly. I played a part in which direction the pendulum ultimately swung.
Based on such factors, it was easy to set up a highly critical or a more forgiving review team, as needed. If, for example, Congress had allocated a million dollars to fund a targeted research program in a specific fiscal year, and time was of the essence, I’d guarantee that the recruited review team, albeit highly qualified, would be more merciful in its critique.
At NIH, I organized review teams in many different scientific disciplines, and, in general, was constantly amazed at how little appreciation one discipline had for the priorities of another, even when they were closely related. Although solutions to today’s problems will require openminded, multidisciplinary thinking, it seemed that everyone’s field of vision was rather parochial.
The one discipline above this parochialism was supposedly statistics. Used to anoint a study’s validity, the discipline is viewed as transcending all subjectivity. But Mark Twain’s statement is more indicative of statistics’ true nature: “There are three kinds of lies: lies, damned lies and statistics.” Twain’s wisdom is reflected in a recent article by Dr. John P.A. Ioannidis, which discusses the flawed statistical assumptions inherent in many studies. He concludes that “for most study designs and settings, it is more likely for a research claim to be false than true. Moreover, for many current scientific fields, claimed research findings may often be simply accurate measures of the prevailing bias.”
SUBJECTIVITY AND INNOVATION:
Although many disorders desperately need innovative solutions, NIH’s prioritization process is generally not well suited to generate them. For example, if only 10 percent of proposals can be funded, applicants are going to play it safe, developing a proposal that won’t be too challenging to the peer-review committee’s prevailing scientific paradigms.
NIH has always had problems funding innovative research. As a rough analogy, its peer-review process is like choosing a movie to rent as a consensus decision with your wife, family and friends, all of whom have different tastes. To get everyone to concur in the choice will only guarantee mediocrity, not inspiration.
The most exciting developments for many disorders are emerging in other parts of the world. Instead of paying attention to these innovations as worthy of further exploration, NIH tends to ignore or dismiss them. Even if there were hundreds of promising anecdotal cases, which there are, they don’t matter much to NIH, which is convinced of its own superiority.
Although NIH-funded investigators are unsurpassed in some areas, they are falling behind in translating their knowledge into real-world therapies. They believe that they are sprinting for the gold medal, while ignoring that athletes from other parts of the world are not only running right next to them, but have also lapped them a time or two.
Yet on whom does NIH rely to set priorities but the runners being lapped? These scientists’ careers rely more on allegiance to the status-quo than the priorities of the disability community.
Finally, pioneering innovators throughout the world are frequently criticized because they haven’t published their work in peer-reviewed journals, but usually it is a frustrating, uphill struggle when they try. Throughout my career, I’ve consistently seen some incredibly mediocre, so-what research published, while most quantum leap material is rejected. We need access to innovative publications, where information, “warts” and all, can be disseminated to researchers who have the potential to provide further answers and insights. As the power of the internet continues to develop, professional journals, once the gatekeepers of knowledge, are also going to be lapped, as the masses quickly overtake them.
“Nothing is more curious than the self-satisfied dogmatism with which mankind, at each period of its history, cherishes the delusion of the finality of its existing modes of knowledge…”—Alfred North Whitehead, English mathematician and philosopher.
When I managed NIH peer review, we only had token interactions with the disability community. As such, our priorities were assigned primarily based on the evaluations of scientists, who usually had little appreciation of the true priorities of individuals with disabilities.
Later, I became director of the Paralyzed Veterans of America’s Spinal Cord Research and Education Foundation. PVA had the heart and soul that was often lacking at NIH. Disability was personal: It was your colleagues, your bosses, your friends. Although all grant applications were subjected to rigorous scientific review, funding decisions were made by scientists or doctors in wheelchairs. Subjective priorities often varied considerably between able-bodied scientists and those with disability.
It is naïve to assume that the nation’s healthcare has been
shaped by merely objective science when you considering economic factors such as the following:
Physicians obtain most of their information on medicines from the profit motivated pharmaceutical industry.
- Most medical consultants to public-health agencies have financial conflicts of interest with the drug industry that profoundly influences their decisions.
- There is a strong association between an author’s published positions on drug safety and their financial relationship to drug companies.
- Drug advertising has increased astronomically in recent years.
- Drug companies spend an average of $13,000 annually per U.S. physician to market their products.
THE IMPACT OF CONSCIOUSNESS
All scientific observation—even at the most fundamental level—is affected by the observer’s consciousness. In this regard the statement, “I’ll see it when I believe it,” is more apropos than its commonly stated converse. Numerous studies have shown that consciousness exerts a significant influence on many different endpoints, ranging from bacterial growth to the heart patients’ outcomes.
Double-blind clinical trials, in which neither the subject nor the physician knows who is receiving the active agent, are considered the gold-standard in research methodology. Although developed to reduce both investigator bias and patient placebo effect, the expectations of the blinded investigators have been shown to influence study outcomes. For example, when there is much enthusiasm for a drug, that excitement percolates into the study, producing more robust effects. Over time, when other, more efficacious agents have been developed and the original investigator’s enthusiasm has waned, the effects become less pronounced and can even disappear statistically.
Studies have actually been designed to measure this effect. Specifically, it has been demonstrated that the beneficial effects that are present with a more enthusiastic investigator (e.g., the drug discoverer) at the helm of a double-blind study, can fade into insignificance under the direction of a more detached skeptic.
The potential influence of consciousness on scientific observation is underscored by numerous quantum-physic theories, especially the famous Heisenberg uncertainty principle. Basically, this theory states that the more precisely the observer measures electron movement, the more uncertain he is of its position and vice versa. Although how much this truth determines our macroreality has been extensively debated, it implies that the very act of observation, including the dynamics of the observation process, changes the object being observed. In other words, the observer and all of his subjective baggage are a part of the experiment.
Echoing the theme put forth by colleagues, noted quantum physicist Dr. John Wheeler said of the behavior of photons: “No phenomenon is a phenomenon until it is an observed phenomenon. The universe does not ‘exist, out there.’ It is in some strange sense a participatory universe.”
In his book, The Universe in a Single Atom: The Convergence of Science and Spirituality, the Dalai Lama relates many quantum-physic theories to Buddhist philosophy, including Heisenberg’s uncertainty principle. For example, under the key Buddhist theory of emptiness, “belief in an objective reality grounded in the assumption of intrinsic, independent existence is untenable. All things and events… are devoid of objective, independent existence.” Later, he notes that “anything that exists…does so only within the total network of everything that has a possible or potential relationship to it.” This philosophy suggests that the scientific observer and the observed are always connected and influence each other’s perceived reality.
In conclusion, there is no such thing as objective science; it is affected at all levels with varying degrees of subjectivity. Indeed, quantum physics suggest that such subjectivity can never be truly eliminated. Like grasping one part of a balloon, the process of progressively, more intensely focusing on one factor will inherently change the characteristics of another aspect. In spite of undeniable contributions, objective science is only one of numerous equally valid ways of looking at the universe. For many scientists, however, it has become equivalent to a religion in which a system of beliefs is dogmatically embraced with passion and devotion. Convinced of its superiority, the faithful eschew the truths obtained by others who do not practice the sanctified liturgy. If we are going to develop big-picture solutions to problems that plague us, we need the contributions of different, but synergistic, ways of looking at the universe.
by Laurance Johnston, PhD
Laurance Johnson has a PhD in biochemistry and molecular biology from Northwestern University. The author of Alternative Medicine and Spinal Cord Injury: Beyond the Banks of the Mainstream, he is a former FDA regulatory scientist and director of a division of the National Institutes of Health. Currently, he is the director of the Spinal Cord Research and Education Foundations, Paralyzed Veterans of America (PVA). For this article, he relied upon the support of many senior-level scientists, with and without disabilities, who provided advice on the concepts expressed in this article.