Articles related to MEDICAL ETHICS

The FDA’s controversial approval of Recarbrio in 2019 marked a deviation from the expected standards of drug effectiveness. Before 1962, US drug approvals didn’t require pre-market proof of effectiveness. Following Senate hearings and the Thalidomide disaster, however, the law changed. Nowadays, FDA approval for new drugs requires substantial evidence of effectiveness from well-controlled investigations. Strikingly, a National Academy of Sciences review found over 30% of pre-1962 drugs to be ineffective, highlighting the importance of these regulations. FDA’s regulations provide a detailed explanation of what constitutes substantial evidence. Though not perfect, these regulations reassure prescribers, patients, and payers of the scientific basis of drug efficacy claims. It’s important to note that an FDA review found 59% of rejected NDAs had deficiencies in efficacy evidence. Nevertheless, the FDA’s controversial approval of Recarbrio in 2019 raised eyebrows. This drug, a combination of imipenem, cilastatin, and relebactam, was approved despite lacking substantial evidence of effectiveness and proper clinical investigations. Disturbingly, FDA officials cited animal and laboratory studies as substantial evidence, a move contrary to legal and regulatory norms. Moreover, the Recarbrio approval showcased other troubling departures from regulatory principles. The FDA failed to require proof of each active component’s contribution to the claimed effect. […]

Today’s understanding is that “pimping” on rounds and similar tactics tend to inhibit rather than promote learning. Yet residents and fellows, and to a lesser extent medical students, continue to complain of demeaning interactions in medical learning environments. Icahn School of Medicine instituted a system to take in reports of such behavior in an attempt to improve the educational environment there. In their model, the instructor is informed that an individual perceived a degrading interaction. The purpose is to allow the instructor to be aware and make changes as needed. But institutions who want to follow the example of the school need to be prepared to allocate the needed resources to do this follow up if the system is to have any benefit.

Most people would agree that a doctor’s behavior is unprofessional, arguably unethical, and certainly unacceptable when he or she uses the wrong treatment, whether willfully or through ignorance, or when they use the right treatment incorrectly. What, then, should we think about researchers who use the wrong techniques, use the right techniques wrongly, misinterpret their results, report their results selectively, cite the literature selectively, and draw unjustified conclusions?

This brief editorial introduces a series of articles describing the medical use of hallucinogens, ketamine, marijuana, and other agents — including the legal and ethical perspectives — in the treatment of various neurologic and psychiatric disorders.

The recent United States Supreme Court ruling raises the bar for evidence that must be shown by the government in order to successfully prosecute doctors who prescribe excessive dosages of painkillers — a huge win for prescribers.