Contribute Try STAT+ Today

Consider this scenario: An experimental Alzheimer’s drug fails two studies, but parsing the data shows the medicine may benefit a subgroup of patients with mild dementia. On that basis, the drug is approved and about 260,000 eligible patients are subsequently treated over the next four years.

Priced at $10,000 per person, the cost totaled roughly $10 billion during that time. To some, this would appear to be a bargain for a drug that combats a pernicious disease, yes? But what if it turns out the drug later failed yet another trial and patients with a mild form of Alzheimer’s weren’t helped, after all? The money —much of it spent by Medicare — would have been wasted and patients’ hopes dashed.

Unlock this article by subscribing to STAT+ and enjoy your first 30 days free!


What is it?

STAT+ is STAT's premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.

What's included?

  • Daily reporting and analysis
  • The most comprehensive industry coverage from a powerhouse team of reporters
  • Subscriber-only newsletters
  • Daily newsletters to brief you on the most important industry news of the day
  • STAT+ Conversations
  • Weekly opportunities to engage with our reporters and leading industry experts in live video conversations
  • Exclusive industry events
  • Premium access to subscriber-only networking events around the country
  • The best reporters in the industry
  • The most trusted and well-connected newsroom in the health care industry
  • And much more
  • Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr.
  • More analyses like the Harvard group need to be done; FDA collected some great info together on phase 3 failures on drugs in many different fields after earlier success:
    So many small trials and sub-group analyses have been “positive” (“Breakthroughs!”) in what is marketed as ALzheimer’s disease. Most dementia is in people in their 80s and a mix of AD and other neurodegenerative changes as well as vascular disease. WHy are people surprised when these things don’t “work”? Those developing them are trying to get an approval based on some surrogate, misleading people into thinking it will really help

  • Great piece. Can you please send it to HHS Secretary Price and FDA Commissioner Gottlieb?

Comments are closed.