This is another paper from my previous doctorate program. This is long and can be complex at times, just know that medicine and health care is a business. In this business, the end goal is to take your money, otherwise known as making a profit. Everyone can see that the shady car salesman is trying to take the money from your pocket and place it into his. For some reason, we have trouble seeing the shady little scientists doing the same thing. Picture Pinky and the Brain. Pinky and the Brain…Pinky and the Brain…One is a genius, the other’s insane. Welcome to the healthcare.
Couglin SS, Barker A, Dawson A. Ethics and Scientific Integrity in Public Health, Epidemiological and Clinical Research. Public Health Reviews. 2012;34:1-13.
“It can be intrinsically unethical because it may involve activities held to be wrong in themselves such as deception, misrepresentation and falsification. It can also be extrinsically unethical because such actions can cause direct harm to individuals and populations where such research is relied upon, negatively impact public trust in and support for research and result in wasted research resources.”
I appreciate the first quote as it discusses the basic ethical principles, as we have already discussed these in the course. There has been little discussion thus far as to how these discussions could affect future research trial that attempt to replicate the original research.
“narrow…way. On this model we might think of integrity as abiding by the relevant research ethics rules or regulations”
This is a very narrow way of looking at integrity. There may be many practicing, which according to the narrow way, do not practice with integrity. Some of the written rules do not account for the “internalistic account”. For example, some insurances only pay for up to ten sessions of traction, whereas there is a sub classification of traction, which will typically only respond well to traction initially, for LBP. For this group, it go against my internal integrity to not provide the treatment in which the research reports the best results.
“…rather than it being quickly concluded that a piece of research is unethical because it does not meet a presumed requirement, such as the need for informed consent.”
This is an excellent statement. It is up to the reader to be able to critically analyze research and come to his/her own conclusions regarding the ethics of the research. If a written informed consent is not applied, but a verbal is implied, is this unethical? We all practice with verbal consent (when we educate and then proceed) and sometimes we practice with an implied consent (when we apply what seems to be a benign treatment such as postural correction).
“…integrity need not always be about following the rules, as much as being able to see that different kinds of moral considerations are important, often conflict, and that sometimes difficult decisions have to be made about priorities.”
This article is excellent in that it places the autonomy of decision in the practitioner’s/researcher’s hands.
“Honest error or scientific differences in the design and conduct or research or interpretation of study findings do not constitute scientific misconduct”
This is a great statement, although I don’t necessarily agree. As professionals, we should attain for the least amount of error. When a grievance is performed, it would be hard to prove that it was performed intentionally.
“When properly executed, study protocols ensure the integrity of the process used to answer a single research question or a series of questions. However, when not adhered to, negative consequences, such as the inability to reproduce a study in order to verify its validity or the loss of confidence in research findings, can ensue”.
I wonder how often studies reproduced, and published, in the field of physical therapy? Rarely is a study reproduced in my readings, but studies typically utilize protocols performed in previous studies. This is discussed at length with clinical prediction rules for the spine. These studies are created utilizing characteristics that are the most common for treating/classifying patients, but follow-up studies to reproduce (confirm) the original study is rarely performed.
Sax JK. Protecting Scientific Integrity: The Commercial Speech Doctrine Applied to Industry Publications. American Journal of Law & Medicine. 2011;37:203-224.
“…companies will publish positive results of their clinical trials. They tend not, however, to disclose negative results of clinical trials in scientific publication, or they down-play the negative results…No regulation requires that industry publish negative results…”
The article is staring with an obvious bias against pharmaceutical companies. At no point in my career have I heard about other industries such as physical therapy being reprimanded for not publishing negative results. Beyond the fact that negative results are not submitted for publication, it is possible that a negative result would not be published in a peer reviewed journal to begin with, as this has been previously documented and is also covered later in the article. “Previous studies demonstrate that industry publications have a bias in that they tend to report positive results of clinical trials.” This initial paragraph sets the tone of attacking the establishment of “big pharm”.
“…(s)tudies funded by pharmaceutical companies were nearly 8 times less likely to reach unfavorable qualitative conclusions than nonprofit-funded studies and 1.4 times more likely to reach favorable qualitative conclusions.”
The author states this as if we, as the readers, should be surprised. As a class, we have already discussed COI, and when those that stand to profit from the results fund the study, we should not be surprised by the favorable results.
“Instead of subjecting themselves to peer review, some members of industry will skirt around this system by creating their own publications, such as symposium issues, which allows them to promote their products without having the academic and scientific community review the research prior to publication”
Although I find this to be unethical, I must say that it is an ingenious way to get around the establishment in order to make a profit. Unfortunately, that profit may be the result of harm. Although I wouldn’t make the same decisions, the decisions are understandable in a profit driven society.
“The tobacco industry also wrote review articles, citing their own work. Policymakers often rely on review articles because they are supposed to provide a summary of the most up-to-date data. Another tactic utilized included suppressing or criticizing research that did not support the tobacco industry’s position”
Again, these statements demonstrate the articles purpose of demonizing portions of the pharmaceutical companies practices. To compare pharmaceutical companies with the tobacco industry, the author is essentially comparing a company that the reader may not have a strong feeling towards to a company that most in America can rally against.
“…the FACT Act did not become law.”
This is shameful. There were good ideas implemented in the FACT Act, that would have allowed the reader to make individual conclusions, instead of taking the authors word regarding the conclusion.
“If the expected value of noncompliance is positive, then the rational pharmaceutical company will ignore the regulation and violate the law because the incentives create a regime where it is cheaper for them to ignore the law”
Although this makes sense, applying a larger financial penalty in order to obtain results does not historically work. For instance, the price of cigarettes continues to rise, but there are still smokers. Obviously there is more than finances at stake with this example, but the authors opened the door by introducing tobacco companies in the argument. The tobacco industry is the reason why this rationale does not work.
“[u]ntruthful speech, commercial or otherwise, has never been protected for its own sake…a state may regulate commercial speech that is provably false, deceptive, or misleading.”
This forces the burden of proof on the state that the company was knowingly being deceptive and misleading. These cases that are proven are the landmark cases, such as the teenage antidepressant case presented in the study. There are few landmark cases presented in the article. On a side note, the teenage antidepressant study was so influential that an episode of Law and Order was created similar to the case.
Rohr JR, McCoy KA. Preserving environmental health and scientific credibility: a practical guide to reducing conflicts of interest. Conservation Letters. 2010;3:143-150.
I had little vested interest in this article, so there are fewer quotes that I found to comment.
“Perhaps the most commonly used strategy to avert undesired environmental and public health decisions is to manufacture uncertainty”
This is not necessarily an evil concept in my opinion. If the evidence is lacking, then “manufacturing uncertainty” is easy. If the evidence is overwhelmingly in support of a specific action, such as the earth circles the sun, then manufacturing uncertainty is impossible. I find the burden for this to be on those in support of those attempting to preserve the environment. For instance, in 2007 the Illinois chiropractors were trying to take mobilizations away from physical therapists. We had ample evidence to demonstrate that we not only owned the technique (thanks to Mary McMillan), but also owned the wording. Because of the evidence cited over the previous century, we were able to prevent this loss.
“…delay regulations that might be necessary to protect environmental health.”
This is an opinion of the author and seeing as how this paper is meant to be a persuasion based paper, it should be omitted or cited if there is evidence to support this.
“Some authors have even argued that conservation science, with its mission of advancing the sience and practice of conserving the Earth’s biological diversity, is normative and biased and thus can be perceived as having a conflict of interest.”
I can appreciate the authors providing this statement and research in the article, because while reading the article I can only think of the conflict of interest that has been established by those attempting to preserve the environment. If one has a vested interest in the outcome of the research, I find it hard to believe that the research is performed without bias.
Dr. Vince Gutierrez, PT 