The FDA is Hazardous to Your Health
Alemtuzumab is used today as an intravenous treatment for a form of leukemia. But 20 years of research centered at Cambridge University also has shown that the action of this drug — depleting immune cells that become misdirected and attack one’s own body — is effective in treating multiple sclerosis.
Under the brand name Lemtrada (a product of Sanofi and its U.S. subsidiary Genzyme), the drug has been approved in recent months for treating MS in 30 countries, including Canada, Australia and all members of the European Union. But on Dec. 27, Food and Drug Administration reviewers at the division level (subject to a final decision by top officials) rejected an application to use the drug here to combat MS. (WSJ)
“In these circumstances, the agency elevated the double-blind, placebo-controlled trial to the level of dogma.”
This response is so typical of government/bureaucracy.
“But on Dec. 27, Food and Drug Administration reviewers at the division level (subject to a final decision by top officials) rejected an application to use the drug here to combat MS.”
So it’s ok to use it to save lives across the ocean, but not here in the States? Something’s broken.
If this drug really works, it could help so many people. What’s holding the FDA back?
From the WSJ article:
The primary reason FDA reviewers gave for rejecting Lemtrada was that the studies demonstrating the drug’s efficacy did not conform to the agency’s standard requirement of double-blind, placebo-controlled drug trials-where some patients, unbeknownst to themselves and their doctors, receive placebo treatments
So, researcher error? It had nothing to do with how the drug worked?
Not error. Because of how the drug works, it wouldn’t have been possible to keep the controls in the dark about being controls.
But the drug works like it should?
From what I’ve read, yes.
I know the FDA’s regulations are meant to keep us safe, but this is taking it too far.
They’re keeping us safe from science. Science is scary.
“They are now demanding another round of trials, with somewhat different procedures, that would take years and cost at least $100 million. Given the magnitude of the results of the already completed trials, the additional trials could add nothing to answering the regulatory question of whether Lemtrada is suitable for clinical use against MS.”
We’re in a poor economic state as it is. Do we really want to spend millions to prove something we already know?
Not to mention the time it would take to do the trials. There are so many people we could help in the meantime.
Yeah. This just seems like a bad decision all around.
“If Lemtrada does no more than postpone progressive, irreversible paralysis for a few years, permitting patients to live normal lives, that is a great blessing even if some of them fall off the FDA grid. But the therapy is also slowing the progression of the disease-some patients have remained free of clinical disease activity for up to 14 years.”
Why would you prevent this? Those poor people.
Not to mention what we could learn about MS by watching how the drug interacted with it.