This is from a newsletter, but interesting to note the info most docs typically evaluate when a patient inquires about Propecia.
Also note Merck’s 2001 advertising budget: $100 million.
Online: ti.ubc.ca/fr/node/60
PDF: ti.ubc.ca/PDF/40.PDF
Some interesting info:
What are the harms and risks of taking this
drug?
In the randomized controlled trials 4.2% of
the finasteride group reported one or more adverse
sexual experiences (decreased libido, erectile dysfunction,
or ejaculation disorder) as compared to
2.2% of the placebo group, ARI* = 2.0%, NNH* = 50
for 1 year (p < 0.05).5 Long-term adverse effects are
unknown at this time.
What other facts should I know about this drug?
The dose for male baldness (1 mg/day) and doses as
low as 0.2 mg/day reduce dihydrotestosterone serum
concentrations by approximately 70%, increase
testosterone serum concentrations by about 20%, and
variably decrease concentrations of prostatic specific
antigen. 3, 5, 6, 8 The clinical significance and long-term
consequences of these effects is unknown at this
time.
What are my legal liabilities if I give in to patient
pressure and prescribe it?
No different than for any other drug you prescribe.
What happens to a company when the DTCA (direct to consumer advertising) is deemed to be misleading?
Two ads for Propecia® in Time Magazine were found to be
misleading by the Division of Drug Marketing, Advertising
and Communications at the US FDA. These ads stated “One
day science will create a pill for hair loss: That day is today.”
And “Starting today, you need not face the fear of more hair
loss”. In both cases the FDA found the ads claimed a broader
benefit than had been demonstrated and advised the company
to immediately discontinue the ads. No other action was
taken.
Conclusions
• DTCA appears to increase drug sales and adds to the pressure
on busy clinicians.
• Before yielding to this pressure, physicians must be able to
convey to the patient in a meaningful way:
• the known benefits (e.g. 6 men have to be treated for one
year with finasteride for 1 to be satisfied with the appearance
of his hair).
• the known harms (e.g. 1 in 50 men treated with finasteride
for l year will have an adverse sexual experience).
• the unknown risks (e.g. long-term finasteride therapy is
necessary to maintain benefit and long-term effects are
unknown at this time).
Note the following at the end:
"This Letter contains an assessment and synthesis of published (and whenever possible peer-reviewed) publications up to March 2001. We attempt to maintain the accuracy of the information in the Therapeutics Letter by extensive literature searches and verification by both the authors and the editorial board.
In addition this Therapeutics Letter was submitted for review to 55 experts and primary care physicians in order to correct any inaccuracies and to ensure that the information is concise and relevant to clinicians.
The Therapeutics Initiative’s objectives are unbiased review and dissemination of therapeutic evidence. Our recommendations are intended to apply to most patients; exceptional patients require exceptional approaches.
We are committed to evaluate the effectiveness of our educational activities using the Pharmacare/PharmaNet databases without identifying individual physicians, pharmacies or patients.
The Therapeutics Initiative is funded by the BC Ministry of Health through a 5-year grant to the University of BC. The Therapeutics Initiative provides evidence based advice about drug therapy, and is not responsible for formulating or adjudicating provincial drug policies.
Therapeutics Initiative - Finasteride.pdf (96.1 KB)