You tell me whar a man gits his corn pone, en I'll tell you what his 'pinions is."
The remarks of Mark Twain's rural philosopher ring true today in the debate over follow-on biologics. In considering a regulatory
pathway for follow-ons, scientists and regulators raise the question of what constitutes equivalence and how it can it be demonstrated. Can two biologics manufactured using different processes be considered the same or equivalent?
In other words, does the process equal the product?
This is, or appears to be, a question of science. Yet it is not always treated as one. Just as it was in Mark Twain's day,
people's views are influenced by how they put bread on the table.
This point came up during a session on generic biologics at November's meeting of the American Association of Pharmaceutical
Scientists. "You can generally tell where a person stands on the issue by the example he gives," said presenter Art Mlodozeniec.
"If he brings up human growth hormone and says the processes and impurities are easy to control, he's from the generic industry
and supports approval for follow-on biologics. If he brings up the challenge of erythropoeitin, he's from the innovator industry
and opposes generics."
So what happens when we approach a scientific question with a bias? Do we not see the truth, or do we just pretend we don't?
Clearly, both occur.
In some cases, we see all the facts and then select the ones that support a certain policy.
In other cases, however, bias can prevent a person from seeing the facts objectively, as Stephen Jay Gould outlined in The Mismeasure of Man. In the early nineteenth century, Gould explains, Samuel Morton measured the volume of skulls from people of various races
to assess differences in brain size, and thus, presumably, innate differences in intelligence. But his predetermined view
affected his results: he got the answer he wanted. It seems clear his errors were unintentional, Gould says, because Morton
published all his raw data, which he wouldn't have done if he were trying to hide something.
As the Morton example shows, personal values, as well as economic interest, can lead to bias. Some may believe, for example,
that it's only right to bring less-expensive generics to market so that more patients receive critical treatments. Others
may think it unfair for innovator companies to share their profits with companies who did not share the research risk and
expense to discover and develop them.
So we must examine our biases and do our best to remain objective. As Ron Reagan concluded in his keynote address at the AAPS
conference, we must not subordinate the truth to political convenience. We must find the truth for ourselves, and speak that
truth. To do otherwise runs contrary to the principles of science.