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In 1796, American physician Elisha Perkins patented “metallick Tractors” for the treatment of various ailments, particularly those associated with pain. They were subsequently rapidly and widely disseminated in the United States and Great Britain based on testimonials and deceptive marketing tactics. Dissemination was facilitated by endorsements from prominent physicians, politicians, and clergymen; quasi-theoretical, handwaving explanations of efficacy based on Galvani’s then-current experiments; and the procedure’s apparent safety and simplicity. However, blinded placebo-controlled trials in Great Britain using sham devices demonstrated that the therapy was ineffective. In response, in the period from 1798 to 1806, Perkinists unleashed a barrage of disinformation (ad hominem attacks, misleading arguments, unethical propaganda tactics, and poetic and graphic satire) to sway public opinion in favor of the fraudulent therapy and against its critics. The disinformation slowed the abandonment of “tractoration”, but higher-level scientific argumentation ultimately prevailed. The Perkinist disinformation campaign had antecedents with the Mesmerist disinformation campaign in the mid-1780s. Similar propaganda tactics are still widely employed to encourage the purchase and use of disproven or fraudulent therapies, as evidenced by propaganda from adherents of acupuncture in response to negative clinical trials and from supporters of unsafe and ineffective therapies promulgated during COVID-19. Full article

The opinion I put forward in this paper is that attention must be paid to health-related quality of life as a study endpoint in lower-risk MDS patients. At the moment therapeutic options are limited in this population. New treatments are predominantly available in clinical studies. In announcing trial publications and during manuscript introductions, quality of life is widely valued as a treatment goal. However, data on health-related quality of life during phase III studies are not published in the original publications, thereby undermining the importance of quality of life as a study endpoint. What seems to be forgotten is that quality of life comprises more than a study endpoint. It is the highest good of lower-risk MDS patients and should also be acknowledged as a safety aspect. Current phase II trials with new medications do not collect data on health-related quality of life, a practice that I consider unethical. In this opinion I demonstrate the current attitude towards health-related quality of life in lower risk MDS patients among leading journals and trial sponsors with several recent examples. I also argue that health-related quality of life should be the main treatment goal in this population. In the event that we shift our focus towards health-related quality of life as the main treatment goal, new treatments could come to a field where gains in overall survival have been marginal over the years. Full article

Both the US and EU have introduced pediatric pharmaceutical legislation to facilitate clinical trials in children and development of better medicines for children. The first concerns were published in 2014 that the European Medicines Agency (EMA)’s Pediatric Committee (PDCO) may be over-enthusiastic and has compelled questionable pediatric clinical trials from pharmaceutical companies. Numerous clinical trials are mandated in rare conditions for which not enough patients exist for even one trial. Furthermore, where these trials are mandated in adolescent patients, the legal age limit of the 18th birthday is confused with a medical age limit and can result in separate clinical trials in adolescent patients that neither make medical nor scientific sense nor will ever recruit enough patients for a meaningful outcome. To confirm our concerns we searched the registry clinicaltrials.gov and found examples for PDCO-triggered unethical trials. We conclude that such trials should not be accepted by institutional review boards (IRBs)/ethics committees (ECs) and that clinical trials resulting from negotiations with EMA’s PDCO need extra careful scrutiny by IRBs/ECs in order to prevent unethical studies and damage to pediatric research and unnecessary risks to pediatric patients. Full article