Here is the link for the entire article---very informative. I will post a snipit so that you can see what he talks about.
http://www.physics.upenn.edu/facultyinf ... kedit1.htm
My purpose was not to criticize Merck (and I did not), but to raise questions about the FDA's approval.
Toward that end, I traveled to Washington to speak with the director of the FDA, Jonathan Wilkin, and
the chief physician responsible for the approval of Propecia, Hon-Sum Ko. I was troubled that not a
single referee for the FDA had commented on the following key pieces of data: a) Conversion of
testosterone to dihydrotestosterone fell to a low level at 0.05 milligrams and stayed the same up to 5.0
milligrams. b) Efficacy had not been established below a dosage of 1.0 milligram. Although side effects
did not occur often at 1.0 milligram, effects of finasteride on both the volume of ejaculate of semen and a
big depression of the prostate specific antigen (PSA) score (a test for prostate cancer) were included in
the data submitted to the FDA.
Through the ombudsman for the FDA I had communications with the FDA and finally made the trip to
Washington to ask why they had approved Propecia at the 1.0 mg dose. I will return to this later in this
article.
Conclusions: I have examined the responses to my article on Propecia by persons representing Merck, as
well as some who represent the FDA. I believe my responses will be compelling to an unbiased reader.
Physicians recognize that the drug companies are driven by a motive for profit. They are aware of the
underfunding and mediocre performance of the FDA in the process of approval of drugs. Very few
articles by physicians appear about this subject. I will soon submit a citizen's request to the FDA in order
to have it reconsider its approval of the dosage of Propecia, and I plan to ask the many dermatologists
from whom I have received e-mail letters to join in this request. But what is really needed is for
physicians, not physicists, to make the effort to improve medical practices. Organizations like the Institute
of Medicine of the National Academy of Sciences need to engage meaningfully in a study of how to make
the FDA a model of what a federal agency should be.
http://www.physics.upenn.edu/facultyinf ... kedit1.htm
My purpose was not to criticize Merck (and I did not), but to raise questions about the FDA's approval.
Toward that end, I traveled to Washington to speak with the director of the FDA, Jonathan Wilkin, and
the chief physician responsible for the approval of Propecia, Hon-Sum Ko. I was troubled that not a
single referee for the FDA had commented on the following key pieces of data: a) Conversion of
testosterone to dihydrotestosterone fell to a low level at 0.05 milligrams and stayed the same up to 5.0
milligrams. b) Efficacy had not been established below a dosage of 1.0 milligram. Although side effects
did not occur often at 1.0 milligram, effects of finasteride on both the volume of ejaculate of semen and a
big depression of the prostate specific antigen (PSA) score (a test for prostate cancer) were included in
the data submitted to the FDA.
Through the ombudsman for the FDA I had communications with the FDA and finally made the trip to
Washington to ask why they had approved Propecia at the 1.0 mg dose. I will return to this later in this
article.
Conclusions: I have examined the responses to my article on Propecia by persons representing Merck, as
well as some who represent the FDA. I believe my responses will be compelling to an unbiased reader.
Physicians recognize that the drug companies are driven by a motive for profit. They are aware of the
underfunding and mediocre performance of the FDA in the process of approval of drugs. Very few
articles by physicians appear about this subject. I will soon submit a citizen's request to the FDA in order
to have it reconsider its approval of the dosage of Propecia, and I plan to ask the many dermatologists
from whom I have received e-mail letters to join in this request. But what is really needed is for
physicians, not physicists, to make the effort to improve medical practices. Organizations like the Institute
of Medicine of the National Academy of Sciences need to engage meaningfully in a study of how to make
the FDA a model of what a federal agency should be.