[e-drug] Post-exposure prophylaxis for anthrax (cont'd)

[John Urquhart <urquhart@ix.netcom.com>]

E-drug: Post-exposure prophylaxis for anthrax (cont'd)
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Following on Dr Offerhaus's comment that it is not an offense in
Europe to prescribe for off-label indications ...

Nor is it an offense or otherwise prohibited for physicians in the
U.S. to prescribe for off-label indications. One does incur a certain
risk that, if things don't work out well, an off-label use may
jeopardize one's standing in a malpractice action, but it is by no
means an open and shut matter.

A memorable example of FDA attitudes on this point occurred when
the FDA issued, in November, 1981, the first approval for post-MI
use of a beta blocker, which was MSD's timolol maleate. The
then-Commissioner, Donald Kennedy, gave a press conference
announcing the approval and stating that it would save 17000 lives
per year. Bill Wardell, then working with Lou Lasagna at the Center
for the Study of Drug Development, in those years at U of
Rochester (now at Tufts U in Boston), had pointed out this
beneficial effect when the first paper reporting on it was published
in 1976, and estimated that its routine use would save 20000 lives
per year in the US alone. Using the Commissioner's figure, 17000 x
6 = ca 100000 deaths that might have been prevented had
regulatory action been taken on an urgent basis in 1976, instead of
1981.

WHO ME?
The FDA was quick to point out that physicians had been free all
the while to prescribe beta blockers for this indication on the basis
of their clinical judgment and their own interpretation of published
evidence.

TODAY
The Agency is much more nimble now than it was then, a fact that
is widely but not universally applauded. It is one of the beneficial
side-effects of the AIDS epidemic, which brought into wide
recognition the consequences of barriers to access to effective
medicines.

John Urquhart, MD, FRCP(Edin)
Professor of Pharmaco-epidemiology, Maastricht University
Chief Scientist, AARDEX Ltd/APREX Corp, Zug, Maastricht, Union
City (CA)
Professor of Biopharmaceutical Sciences, UCSF, San Francisco
email: urquhart@ix.netcom.com


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