STAT+: Pharmalittle: We’re reading about concerns over a rare disease drug, pharma payments to docs, and more — SkimNews
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- Vykat XR, Neurocrine Biosciences' drug for Prader-Willi syndrome, has been linked to 7 deaths and nearly 100 hospitalizations since its approval 18 months ago.
- Patient advocates and some experts are expressing growing alarm about Vykat XR's safety profile, two months after an open letter flagged potential safety issues with the therapy.
- Case reports on the deaths and hospitalizations submitted to regulators do not prove causality, as many cases involved complex medical issues and multiple medications.
- Some experts maintain the available evidence is sufficient to conclude that Vykat XR is causing unacceptable harm to patients.
- A Cochrane review found that drugmaker gifts and payments to physicians increased inappropriate prescribing and prescription volume, likely contributing to rising health care costs.
- The same review concluded that conflict-of-interest policies restricting industry-physician interactions probably improved prescribing practices.
Why it matters: Prader-Willi patients on Vykat XR now face a drug under escalating safety scrutiny, with 7 deaths and ~100 hospitalizations reported since approval — though the source cautions case reports don't prove causation. The Cochrane findings separately give hospital systems and policymakers fresh evidence that limiting drugmaker-physician payments probably improves prescribing quality.
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