Re: GLP/GMP (communication by Anonymous through the Ombudsman)
Ioannis Papayannopoulos (iap@iname.com)
Tue, 10 Nov 1998 20:56:09 -0500
It is clear that the anonymous individual, who responded through the ABRF
Ombudsman to the GLP/GMP issues surrounding the source of a product and the
need to demonstrate that it is safe from BSE, is very ignorant about how
drugs are discovered and produced and also how they are tested and approved
in a highly regulated environment. Either that, or he/she has malicious
intent, as statements of the type "one form [of the product] was cheaper
for the drug company to make and thus the company made more profit and
those holding its stock are able to retire at 55 rather than 65" might lead
the unbiased observed to surmise. Nevertheless, I am prepared to give the
anonymous individual the benefit of the doubt and assume that he/she is
simply ignorant. Taking this person's scenario, then, first, it is highly
unlikley that the FDA would approve a pharmaceutical product when a safer
version of it is also available, even if those in charge of the company
making the less safe product were naive or greedy enough to push ahead (and
there are examples, in the public domain, that bear me out on this).
Second, even if no safer alternative were available, the benefits from such
a product would have to be tremendous to be approved in spite of serious
risks. It is naive to assume that any pharmaceutical is completely safe,
and there always has to be a comparison of the relevant risks and benefits.
For example, chemotherapy or radiation treatment is hardly safe, yet the
alternative, death from cancer, is worse, in the minds of most people
including regulatory agencies all over the world (and, incidentally, as I
am personally aware, also including the parents of a "very very precious 6
year old daughter", to use the anonymous correspondent's words which
clearly aim on an emotional appeal rather than logical reasoning).
Similarly, organ transplantations often fail, but the alternative, certain
death, is worse, and many people opt for transplantations, however
uncertain the outcome. Even blood transfusions, although much safer than
they were 15 years ago, still carry a non-zero risk for contracting HIV;
yet this has not stopped people from having them, even in non life
threatening situations like cosmetic surgery.
The bottom line is, there are always risks involved in medical procedures
and in taking medications, and it's a matter of weighing carefully risks
and benefits, something that the overwhelming majority of those employed in
the pharmaceutical industry take very seriously, and perform quite well, as
does the FDA. All of which the anonymous correspondent apparently fails to
comprehend. Anonymity, however, is no excuse for slopy thinking.
Ioannis Papayannopoulos
Astra Arcus USA, Inc.
Worcester, MA
P.S. The opinions stated above are, obviously, my own, and my affiliation
is offered for purposes of identification only.