Fast track folly
I think it’s time for an intervention.
It’s a hard decision to make. It’s even harder to get friends and family together to confront someone who’s out of control.
But we have to do it.
It’s time to sit down with the FDA and just lay it out… “You’re out of control. You’re hurting others.”
Of course, the FDA has gone so far around the bend, it might actually be too late for tough love to have any effect.
Unfortunately, the agency won’t suffer. Not at all. The U.S. public is going to get the bad end on this deal. And the damage could go on for many years.
Dragging us down the primrose pathway
A new study from Canada might give you a bit of déjà vu.
Researchers followed the history of more than 400 drugs approved in Canada over a 15-year period.
Results…
- One of every four drugs was either removed from market or serious safety warnings were added
- One of every two drugs given fast track approval required safety intervention
- Seven of every 10 drugs given fast track approval did not represent a “major therapeutic advance”
These results parallel the approval trends we’ve seen with the FDA. And it’s about to get worse. Much worse.
The Archives of Internal Medicine (AIM) published the Canadian study. In the same issue, an editorial reveals these four disturbing provisions in the FDA’s Expedited Drug Development Pathway…
1) Reduce number and size of clinical trials
2) Require less evidence of efficacy
3) Begin drug approval reviews BEFORE completion of testing
4) Set short review deadlines
So instead of reforming this process to protect consumers, the FDA is streamlining it to make it easier. And you know who benefits from that: Drug companies.
Of course, the FDA requires follow up safety trials for all of these fast-tracked drugs. That makes it SEEM like safety is still a key concern. But the British Medical Journal has blown the lid on that fantasy.
As I mentioned recently, studies in the BMJ reveal chronic “incomplete data disclosure” in clinical trials. To put it more bluntly… Drug company trials can’t be trusted.
So with zero trust, what can we do? The AIM editorial offers an interesting suggestion. Put a warning on every new drug that reads, “New Drug: Caution Indicated.”
I like the idea, but those four mild words don’t even begin to communicate the frightening reality. And that’s something EVERY patient needs to be aware of, in no uncertain terms.
Sources:
New Drug: Caution Indicated Comment on
“New Drugs and Safety”
New Drugs and SafetyWhat Happened to New
Active Substances Approved in Canada Between 1995 and 2010?
Just how many new diabetic drugs are in the pipeline?
Graham
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