Straight to the point

I read the July 19, 2024 issue of the Journal of the American Medical Association and realized that my profession, or at least the publication of medical articles, has seemingly become just an extension of a political party. It reinforced my memory of 50 years ago, thumbing through the 1938 issues of the Wiener Mediziniche Wochenshrift after the Anschluss, and viewing the articles. The editorial board in Vienna had changed overnight. Ideology was paramount. 

Two articles in the current issue of JAMA caught my eye. They were written in English in 2024 in a once-respected United States journal, but they could have been written in 1938 in German in an equally once-respected Viennese medical journal. The first was Elevating the Importance of Local Elections, dated June 16, 2024. While I agree that local elections are indeed important, my reasoning is slightly different from that of the authors. This is the part that jumped out at me:

Consider school boards. They shape hyperlocal budgets, curricula, and resource allocation.⁶ School boards recently have become a battleground for social change, often to the detriment of students. Across the country, agitators have disrupted school board meetings and promoted school board candidates with policy agendas that include rolling back COVID-19–related protocols, prohibiting teaching of critical race theory, erasing education about racism and slavery, banning books, and promoting policies that marginalize lesbian, gay, bisexual, transgender, queer (or questioning), asexual (or allied), intersex youth. These policies directly harm students who are often mandated to continue their education in unsafe, occasionally hostile environments. In many cases, agitators do not live in or have students in the school district; they gain influence by showing up when others stay home, taking advantage of historically low participation at school board meetings and in local elections.

Other elected offices may be more relevant to health than their titles suggest. For example, the Texas agriculture commissioner plays a critical role in the oversight of health education for the state. The Texas railroad commissioner has little to do with trains, but does play an important role in policy decisions affecting climate change, another topic critically relevant to health. Races for such positions have an undeniable effect on the health and well-being of communities, yet they are frequently ignored. Beyond such seemingly obscure positions, consider the legal philosophy of locally elected judges, the strategic direction of prosecutors, and the votes on school levies or funding for a community library.

I would have applauded the authors if they realized that opinions other than theirs may be just as reasoned, valid, and supportable.  Unfortunately, they make no secret about onto which side of the cultural divide they fall.  Those who disagree with them are aligned with “agitators,” those “banning books,” “erasing history,” contributing to “hostile environments,” and “taking advantage” of low participation at school board meetings. So much for “democracy.”

That is certainly their right. They have no legal obligation to be impartial. However, I fault medical and scientific publishing itself. For years, we have been required to list any conflict of interest when we submit an article for consideration for publication. This has been firmly established as a means to protect the readers from overt or implied bias. Normally, this is directed at authors who may have a financial interest in the agents or procedures they recommend in their article. But what about non-financial interests? 

During the past 4 years, medical and scientific journals have broken with tradition to make political recommendations which the authors claim have medical or scientific ramifications. Both Scientific American and the New England Journal of Medicine formally endorsed Joe Biden for President in 2020. The last one went so far as to claim it was for the poor handling of Covid by the Trump administration. With the revelations of the tremendous harm done to children, business, and general health by the mandates and lockdowns of the Biden administration, I wonder if they wish they could reconsider their actions? Sadly, I doubt it.

A line has been crossed in scientific and medical publishing. Should we now demand authors disclose political conflicts of interest when their primary message is political? I think we should, for the same reasons we demand disclosure of financial conflicts of interest. One can very simply utilize the website followthemoney.org to check on the financial donations of authors making a primarily political statement in a medical article. I do. Sometimes I am surprised, but most of the time I am not.

This unabashed politicization of the medical literature leads into the second article in the same issue, Protecting Participants Is Not the Top Priority in Clinical Research. It is even more troubling, in a very personal and profound way. Those familiar with this Substack will know from prior postings that two of my mother’s first cousins were murdered by Croatian Fascists in the Jasenovac Death Camp. 

One of my reasons for spending my junior undergraduate year at the University of Vienna was an attempt to understand how a culture that produced Mozart could also have produced death on an industrial scale. A deeper discussion can be found in reading those prior Substack posts. For here, let it suffice that I found that there was not a twisted German/Austrian/Croatian gene. Any society, given the right set of circumstances, could fall prey to this madness. And in many ways, it happened right here, at least at the philosophical level, in 2020.

The author’s main message, it seems, is that the Declaration of Helsinki regarding medical ethics in human subject research should be scrapped. It is necessary for the full impact of this article that much of it be quoted verbatim:

The Declaration of Helsinki,¹ adopted 60 years ago by the World Medical Association, is widely viewed as “the ‘cornerstone’ document pertaining to medical research ethics.”² Yet it endorses a core premise that is wildly inconsistent with the long-accepted understanding of the ethics of research with human participants. Its endorsement of that premise has real consequences that are harmful to the ability to conduct research ethically. It is long overdue for that position to change. And there is now a particular opportunity to make that change: the World Medical Association is currently engaged in a procedure to revise the declaration…

The problem arises when researchers turn from the ethics of clinical care to the ethics of research. When a physician is conducting research, the goal becomes that of trying to answer a research question. In doing that, the physician’s activities may no longer always be in the best interests of the research participant…(Emphasis Added)

Society has created special rules relating to research precisely because, absent these rules, physicians conducting research would be behaving in an unethical and illegal manner. (Emphasis added) They would be doing things to the research participants that violate the core ethical duty relating to almost always prioritizing the best interests of those patients.

But it is recognized that it is important to everyone that research be conducted. So, a distinct set of rules for the category of research was created, and those rules manage the conflict of interest between doing what is needed to answer a research question and prioritizing the well-being of the participants. This set of rules weakens the requirement that everything be in the best interests of the participants, and replaces that requirement with an altered set of rules that allows, within limits, things to take place that might not be in their best interests.

This is the well-recognized view of how the current system of research ethics functions. It is so noncontroversial that even leaders in one of the prominent efforts to rethink research ethics—the move toward a learning health care systems approach that would dramatically rewrite those rules—do not hesitate to recognize this core aspect of the existing system: “Participation in clinical research does not always serve patients’ best interests; (Emphasis added) studies, for example, often include burdensome or risky procedures that hold no prospect of direct medical benefit but that are justified by the need for scientific validity and the social value of research.”⁵

And this leads directly to the highly problematic statement in section 8 of the Declaration of Helsinki: “While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.”¹

It is impossible to be following this precept and to also be conducting much of the research that currently is taking place. Indeed, a “corrected” version of this statement would say just the opposite: “Given that the primary purpose of medical research is to generate new knowledge, this goal will in many instances take precedence over the interests of individual research subjects. This circumstance is acceptable.”(Empahsis added)…

Perhaps we should not be particularly troubled by this problematic statement. Maybe it can be treated as harmless puffery, an attempt by an organization of physicians (the World Medical Association) to be self-serving and protect its image, telling the public what it expects to hear: that of course, even in clinical research, no physician will ever do anything that is actually harmful to a research participant. Unfortunately, that is far from the actual case. The statement in the declaration creates very real harm. (Emphasis added)

In endorsing an incorrect message about the extent to which research prioritizes the interests of participants, the declaration makes it more likely that researchers will relay that false belief to research participants, thus making informed consent even more problematic. Based on section 8 of the declaration, presumably it would be perfectly appropriate to include the following text, prominently, in the consent form for many clinical trials: “Nothing that is done to you in this clinical trial will ever be permitted to take precedence over your best interests. Advancing your best interests will always be prioritized, even when doing that is contrary to the goal of answering the research question.” But that statement is not only factually wrong regarding what actually takes place in a large percentage of clinical trials, it would end up worsening the therapeutic misconception. (Emphasis added THIS IS THE MOST TROUBLING STATEMENT IN THIS ARTICLE!!!) It would wrongly reassure research participants when they need to instead be warned about their likely misunderstanding of what happens in clinical trials.

Surely it should be troubling when the most prominent international code of ethics contains a statement endorsing a practice that contradicts an important aspect of how clinical trials are actually conducted. (Emphasis added) It is time to go beyond merely occasionally recognizing this as an acceptable idiosyncrasy of the declaration, and to instead work to replace that statement with its correct—and 180-degree opposite—message. That would be an appropriate tribute, indeed, to the huge amount of good that the declaration has accomplished as its 60th-year anniversary is celebrated this June.

I keep hoping that I am reading this journal article incorrectly, but after multiple readings, I come to the same conclusion. Frankly, I am utterly and completely flabbergasted…I am no stranger to clinical research, having been one of the original investigators pioneering the use of botulinum toxin (Botox) for facial movement disorders. It entailed detailed observation and reporting to the Principal Investigator and sponsor of the research of all positive and potentially negative results on a regular basis.

In the past, safety as well as efficacy, was one of the primary subjects of the research. Stopping rules, conditions that would demand an immediate halt to the research, were an integral part of the protocol. The author seems to indicate that these are just no longer essential. Perhaps it is just sloppy language, but it raises serious ethical concerns, at least in my mind.

To think that an ethical researcher would feel allowed and even entitled to KNOWINGLY endanger patients to answer a research question, no matter how pressing, is just totally unacceptable. I have visions of this article from 1990 on the Dachau Hypothermia Experiments. Perhaps the seeds were sown even then, as the article concludes:

Inferior science does not generally come to the attention of the ethicist because it is usually discarded by scientists. Ethical dialogues deal with work of sound scientific but controversial moral content, and the mere fact that a debate is conducted implies that the subject under consideration has scientific merit. If the shortcomings of the Dachau hypothermia study had been fully appreciated, the ethical dialogue probably would never have begun. Continuing it runs the risk of implying that these grotesque Nazi medical exercises yielded results worthy of consideration and possibly of benefit to humanity. The present analysis clearly shows that nothing could be further from the truth. Although the Dachau experiments opened the dialogue about an important ethical issue, the discontinuation of debate about these experiments should not bring an end to exploration of the larger subject —the implications of the use of ethically tainted data. But the Dachau study is an inappropriate example for that purpose.

This 1990 article from the New England Journal of Medicine seems to say that if the studies were just done with more rigor, at least the ethical considerations of using them could be debated. The current article from the 2024 Journal of the American Medical Association seems to go way beyond that circumstance. And yet, in looking back on Covid, perhaps I am just a dinosaur and the author is indeed describing the reality of current medical research. If so, I would be reluctant to ever recommend a friend or family member, or indeed, anyone, participate in clinical research ever again! 

Albert Einstein is reported as saying: The world will not be destroyed by those who do evil, but by those who watch them without doing anything. He was right.

Republished from the author’s Substack

Source: Brownstone Institute Read the original article here: https://brownstone.org/