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July 2006
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FDA — long past time for major reform

Even before the FDA made its widely ridiculed statement about medical marijuana, it was common knowledge outside the agency that the FDA had lost most of its scientific credibility, sacrificed to political and financial interests.
Oddly, some of the staff seemed oblivious, as demonstrated in this remarkably bizarre hymn to the FDA written by a staff member for the FDA’s Centennial celebration. There is video, and the lyrics:

One century past, a people’s hope fulfilled
By an act conceived for safe medicine and food
Protecting rights that our founding fathers willed
To life and liberty, to happiness pursued.

We honor those who carried on before
O’er these hundred years, public safety to secure
For food, vaccines, drugs, devices, blood and more
They strove to see these goods effective, safe, and pure.

In field and lab, in workplace far and near
From both civilian and commissioned corps
A call goes forth in this centennial year
That this rich heritage continue evermore.

Now in this proud hour, a vibrant vision thrives
True to our mission, whate’er the challenge be
With science our guide, we rededicate our lives
To help create a future healthy, safe, and free.

I love the idealism. But the practical reality is much, much different.
A recent survey revealed some pretty distressing facts. The results (released on Thursday) are based on 997 FDA agency scientists who returned the survey (out of almost 6,000 who were approached). The survey found:

  • Almost one in five (18 percent) responded, “I have been asked, for non-scientific reasons, to inappropriately exclude or alter technical information or my conclusions in an FDA scientific document.”
  • More than three in five (61 percent) knew of cases in which “Department of Health and Human Services or FDA political appointees have inappropriately injected themselves into FDA determinations or actions.”
  • Three in five (60 percent) also knew of cases “where commercial interests have inappropriately induced or attempted to induce the reversal, withdrawal or modification of FDA determinations or actions.” […]
  • One-fifth (20 percent) say they “have been asked explicitly by FDA decision makers to provide incomplete, inaccurate or misleading information to the public, regulated industry, media, or elected/senior government officials.” In addition, more than a quarter (26 percent) feel that FDA decision makers implicitly expect them to “provide incomplete, inaccurate, or misleading information.”
  • Two in five (40 percent) said they could not publicly express “concerns about public health without fear of retaliation.” More than a third (36 percent) did not feel they could do so even inside the confines of the agency.

When science is subverted by politics, it endangers the lives of the citizens, it robs the nation of some of its greatest tools for advancement, and it weakens the country.

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