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Tag: Pharmaceutical Research

  • Question raised over injectable meloxicam approval in cats

    What the study found

    The authors say injectable meloxicam is still widely used in feline practice even though it has been associated with acute kidney injury, or AKI, which means sudden kidney damage. They also state that evidence of this association appeared in a clinical trial submitted to the U.S. Food and Drug Administration but was omitted from the published journal version.

    Why the authors say this matters

    The authors suggest these issues raise questions about the approval process for meloxicam and about the influence of pharmaceutical industry sponsorship on veterinary prescribing practices and policy. They also note ethical concerns because the trial was financially sponsored by the drug manufacturer and veterinary organizations promoting meloxicam were also financially supported by that manufacturer.

    What the researchers tested

    This is a viewpoint article rather than a primary experiment. The authors examined information from a clinical trial submitted to the U.S. Food and Drug Administration as part of a New Animal Drug Application and compared it with the published version in the Journal of the American Veterinary Medical Association.

    What worked and what didn't

    The abstract says the submitted trial data showed an association between injectable meloxicam and AKI. It also says those data were not included in the published journal article, which the authors present as a key concern.

    What to keep in mind

    The abstract does not provide detailed study methods, sample size, or the full evidence supporting the AKI association. It also does not describe limitations beyond the concerns the authors raise about publication, sponsorship, and approval.

    • Injectable meloxicam is described as still widely used in cats despite AKI concerns.
    • The authors say FDA-submitted trial data showed an AKI association.
    • They state those data were omitted from the published JAVMA version of the trial.
    • The paper raises ethical concerns about manufacturer sponsorship and veterinary promotion.
    • The article questions meloxicam's approval process and industry influence.

  • Zuranolone approval is presented as a regulatory case study

    What the study found

    The authors argue that the approval of zuranolone for postpartum depression and the denial of approval for major depressive disorder can be seen as a case study in recent drug regulation. They also say the approval process was unusually fast because the drug received priority review and fast-track designation.

    Why the authors say this matters

    The authors suggest that policy changes meant to improve innovation and efficiency may have lowered the evidence threshold for drug approval. They conclude that this may shift the balance of benefits and harms for newly approved medicines in ways that are not in the public’s best interest.

    What the researchers tested

    The researchers examined the clinical trial data submitted by the manufacturer for zuranolone. They also discussed the drug’s review under U.S. Food and Drug Administration processes, including priority review and fast-track designation.

    What worked and what didn't

    The abstract states that zuranolone was approved for postpartum depression in August 2023 after a 7-month review. It also states that approval for major depressive disorder was denied. The authors say the designation allowed submission of fewer trials and evaluation based on surrogate outcomes rather than clinically relevant outcomes.

    What to keep in mind

    The abstract provides the authors’ interpretation, but it does not give the full trial results in the summary available here. It also does not describe detailed limitations beyond noting concerns about the evidence standard used in the approval process.

    • Zuranolone was approved by the U.S. Food and Drug Administration for postpartum depression in August 2023.
    • Approval for major depressive disorder was denied.
    • The review took 7 months because the drug received priority review and fast-track designation.
    • The authors say fast-track designation can allow fewer trials and reliance on surrogate outcomes.
    • The paper frames zuranolone’s approval as a case study in recent drug regulatory science.

  • Private hospital managers support regulating healthcare advertising

    What the study found

    The study found that most private hospital managers interviewed in Istanbul supported legal regulation of healthcare advertising. They also expressed concern about the rise of social media advertising and about ethical breaches.

    Why the authors say this matters

    The authors conclude that healthcare providers should protect patients' right to accurate, unbiased information while avoiding misleading content. The study suggests these findings are relevant for policymakers seeking a more ethical and transparent healthcare communication environment.

    What the researchers tested

    The researchers used a qualitative design and conducted in-depth, semi-structured open-ended interviews. They interviewed 12 private hospital managers in Istanbul selected through purposive sampling: 4 general managers, 4 public relations managers, and 4 corporate communications and marketing managers.

    What worked and what didn't

    Six main themes emerged from the inductive thematic analysis: views on healthcare advertising bans, feelings about healthcare advertisements, views on healthcare advertising risks, willingness to advertise their own hospitals, knowledge of advertising regulations, and comments on the distinction between promotion, information, and advertising. Most managers strongly supported regulating healthcare advertising through legal frameworks, while also saying that social media advertising makes it harder to distinguish advertising from promotion and information.

    What to keep in mind

    The available summary describes a small interview sample from private hospitals in Istanbul, so the findings are limited to that context. The abstract does not describe additional limitations.

    • Most interviewed managers supported legal regulation of healthcare advertising.
    • Managers were concerned about uncontrolled social media advertising and ethical breaches.
    • They said it can be hard to distinguish advertising, promotion, and information.
    • The study identified six themes from interviews with 12 private hospital managers.
    • The authors emphasize accurate, unbiased patient information.