Are Most Clinical Trials Unethical?

Michel Shamy
American Council on Science and Health
Originally published May 21, 2018

Here is an excerpt:

Therefore, to render RCTs scientifically and ethically justifiable, certain conditions must be met. But what are they?

Much of the recent literature on the topic of RCT ethics references the concept of “equipoise,” which refers to uncertainty or disagreement in the medical community. Though it is widely cited, “equipoise” has been defined inconsistently, is not universally accepted, and can be difficult to operationalize. Most scientists agree that we should not do another study when the answer is known ahead of time; to do so would be redundant, wasteful, and ultimately harmful to patients. When some estimates suggest that as much as 85% of clinical research may be wasteful, there is a strong imperative to develop clear criteria for when RCTs are necessary. In the absence of such criteria, RCTs that are unnecessary may be allowed to proceed – and unnecessary RCTs are, by definition, unethical.

We have proposed a preliminary set of criteria to guide judgments about whether a proposed RCT is scientifically justified. Every RCT should (1) ask a clear question, (2) assert a specific hypothesis, and (3) ensure that the hypothesis has not already been answered by available knowledge, including non-randomized studies. Then, we examined a sample of high quality, published RCTs and found that only 44% met these criteria.

The information is here.

Selling Bad Therapy to Trauma Victims

Jonathan Shedler
Psychology Today
Originally published November 19, 2017

Here is the conclusion:

First, do no harm

Many health insurance companies discriminate against psychotherapy. Congress has passed laws mandating mental health “parity” (equal coverage for medical and mental health conditions) but health insurers circumvent them. This has led to class action lawsuits against health insurance companies, but discrimination continues.

One way that health insurers circumvent parity laws is by shunting patients to the briefest and cheapest therapies — just the kind of therapies recommended by the APA’s treatment guidelines. Another way is by making therapy so impersonal and dehumanizing that patients drop out. Health insurers do not publicly say the treatment decisions are driven by economic self-interest. They say the treatments are scientifically proven — and point to treatment guidelines like those just issued by the APA.

It’s bad enough that most Americans don’t have adequate mental health coverage, without also being gaslighted and told that inadequate therapy is the best therapy.

The APA’s ethics code begins, “Psychologists strive to benefit those with whom they work and take care to do no harm.” APA has an honorable history of fighting for patients’ access to good care and against health insurance company abuses.

Blinded by RCT ideology, APA inadvertently handed a trump card to the worst apples in the health insurance industry.

The article is here.