By Michael Buyze, L.AC., MSOM
We’ve heard quite a bit of conversation recently about information, misinformation and disinformation, especially related to COVID-19, it’s origins, treatments and the development of a vaccine for it.
“Follow the science” has become a mantra that has been employed to suggest that “the other side” is wrong.
Many of the folks that have invoked the “follow the science” mantra, lack an understanding of what’s being said. In this article, I will provide some basic information on the application of the scientific process as it relates to healthcare in general and the pharmaceutical industry in particular. The purpose of this article is to help improve the quality of medical decision making for you and those you care about.
Underlying this article is my fundamental belief that the practice of medicine is a collaboration in which the medical provider assumes the role of the expert regarding any medical treatment he/she is recommending. Further that the medical history and current condition of the patient is well known to the medical provider and a recommendation is made from that perspective. It should be made with full understanding and disclosure of the risks and benefits of the procedure juxtaposed over the patient’s present situation. Furthermore, it is the provider’s job to offer an explanation and recommendation in a manner that the patient can understand which allows the patient to make an informed decision.
The purpose of research is to test a theory on a sample group and determine if the theory holds true. When a drug company gets an idea for a drug they must submit research to the FDA (Food and Drug Administration) for approval. There are several steps to this process with a huge financial cost (usually millions of dollars) so it is not taken lightly. There are two primary things that must be proven, which are safety and efficacy.
Safety means that the drug can be taken by humans (especially people with any significant health risks). Efficacy means effectiveness or, to put it simply, that the treatment works.
There are many ways to approach research, but the approach considered to be the “gold standard” in the world of healthcare is the “double blind, placebo controlled” clinical trial. Research can certainly be influenced by bias and it is the “double blind, placebo controlled” approach that best eliminates bias.
The term “double blind” refers to the fact that both the subjects and the researchers are “blind” to the designation a subject has. In other words, nobody knows which “group” the subject belongs to. The “placebo controlled” term actually has two parts. The first is that there is a “control” or “comparison” group that does not receive the real treatment. In the case of a medication study, they will get a “placebo” or so-called “sugar pill.” So when you combine these ideas you get two (or more) groups. The “experimental group” gets the treatment being studied (real pill), the “control group” gets the placebo, and neither the subjects getting the pills nor the researchers handing them out know who is getting the real pills and who is getting placebo. Everything is tracked “in code” so to speak.
These studies are even stronger if all study participants are randomly assigned to one group or the other such that age, sex, lifestyle habits, body weight, and other potentially relevant factors are otherwise equal in both groups.
When the study is complete, the data is unblinded and statistically analyzed to determine if there was any “significant difference” (a statistical term), between the groups. The bigger the number of participants, the more powerful the study.
Once the data is released, it is interpreted and published in a “peer-reviewed” journal. This means that other experts have a chance to review the data, interpretation and conclusions. This is typically done by “peer reviewers” upon submission to the journal for publication. The reviews have the opportunity to question and comment on the results and conclusions made by the researchers. Sometimes changes are made to statistical procedures or the way conclusions are worded.
Once accepted for publication the study is published and released for general consumption. For studies where there exists significant public interest, news releases to media outlets will give previews of what is coming and the conclusions that are being drawn.
This information comes to healthcare providers in the form of medical journals. “Article reprints” are often provided by the manufacturers to support the marketing practices of the drug and are presented to medical professionals and their staff along with promotional materials to support the informed use of the product. Additionally, the researchers are often invited to professional meetings to present their findings to healthcare professionals in attendance. This is one of the ways that the pharmaceutical industry interfaces with the providers in the healthcare system.
In Part 2 of this series we will examine how scientific information can turn into misinformation and even disinformation and how science can fall victim to politics and how that can impact medical decisions.
Michael Buyze, L.Ac. is a healthcare entrepreneur with nearly 40 years of experience in healthcare and expertise in acupuncture, traditional Chinese medicine, functional medicine, clinical exercise physiology, and nutrition. He owns and operates East Wind Healthcare, an acupuncture and wellness clinic with a 23-year history of helping people in the Fox Valley with offices in Appleton, Oshkosh, and Fond du Lac. He holds Master of Science Degrees in Chinese Medicine, Business Administration and Exercise Physiology. He and his team offer acupuncture as well as wellness programming for acute and chronic pain as well as many chronic disease states. Acupuncture consultations and wellness consultations are available by appointment. Contact information: East Wind Healthcare, 3000 N Ballard Road, Unit#3, Appleton, WI 54911; 404 N. Main St., Suite 201, Oshkosh, WI 54901 and 180 Knights Way, Fond du Lac WI 54935 (inside Fox Valley Wellness); Tel: 920-997-0511; Website: eastwindhealthcare.com