Connection With Our Past

The photos of Henry David Thoreau, Mahatma Gandhi, Reverend Dr. Martin Luther King, Jr. and Dr. Francis Kelsey are posted in this section to connect the current effort of Thoreau-FDA.com to the larger historical context -- the tradition of resistance to oppression or speaking truth to unjust corporate power, as in the case of Dr. Kelsey.  We continue that tradition by resisting professional oppression.  Thoreau-FDA.com also commits to free present and future lower level civil servants from outside interests that pressure them to find their drug review decisions approve or acceptable, when their own evaluations of information and data, for which they are responsible, warrant otherwise.  In particular, upper level FDA managers sometimes seek to relieve themselves of their duties or actually do so, by pressuring lower level FDA staff to change their withhold approval review decisions.  By doing so, an upper level FDA manager can exempt him or her self from documenting their reasons for overruling withhold approval recommendations of lower level FDA staff.  We assert that the well considered decisions of lower level FDA staff must be accepted by and incorporated into subsequent higher level reviews.  This ensures a thorough and authentic evaluation at each organization level, as it fits into the sequence of steps throughout any line of review at the US FDA.  And thorough high objectivity reviews maximize public health safety.   

The scope of the effort of Thoreau-FDA.com is global in its appeal and local in its immediate action.  Globally, we intend to offer a model for consideration by individuals in their roles in government bureaucracies and corporate administrations worldwide.  However, the scope of our immediate effort is local.  We want Dr. Von Eschenbach to acknowledge professional oppression, and provide written policy that works to eradicate its presence in the US FDA lines of drug review.  Specifically, we want to ensure an end to undocumented top down approve directives and requests.  We also want to prevent further retaliation against lower level FDA staff who publicly expose dangerous deadly products. 

Our website, Thoreau-FDA.com, uses the last name of a great American, Henry David Thoreau, as an acronym for the principle that guides the actions of most US FDA staff and managers in their regulatory and pre-approval reviews.  That principle is

Thorough – High – Objectivity – Review – Ends – Are – Us – FDA

Martin Luther King, Jr., another great American and spiritual leader, in chapter 2 of his autobiography writes, and we quote in part,

“ … During my student days I read Henry David Thoreau’s essay “On Civil Disobedience” for the first time.  Here, in this courageous New Englander’s refusal to pay his taxes and his choice of jail rather than support a war that would spread slavery’s territory into Mexico, I made my first contact with the theory of nonviolent resistance.  Fascinated by the idea of refusing to cooperate with an evil system, I was so deeply moved that I reread the work several times.

I became convinced that non-cooperation with evil is as much a moral obligation as is cooperation with good.  No other person has been more eloquent and passionate in getting this idea across than Henry David Thoreau.  As a result of his writing and personal witness we are the heirs of a legacy of creative protest.  …”  

The history of dissent in the United States arose with its birth when our founders resisted an unjust ruling monarch.  And, dissent and resistance to oppression have been recorded in other cultures and times.  For example, also in recent history, Mahatma Gandhi, another great spiritual leader, devoted and gave his life to freeing the people of India from oppressive outside rule. 

History teaches that longstanding entrenched injustices are extremely difficult to change for the better.  And it shows that change sometimes is accomplished, only after the deaths of those who initiate action to reverse the injustices, they witnessed and bore during their lifetimes.  Consider that it took over 60 years, from the time that Elizabeth Cady Stanton presented the Declaration of Sentiments at a women’s rights convention in 1848, until the passage of the 19th Amendment in 1920, granting women the right to vote in the United States.  That was 18 years after Stanton’s death in 1902.  As another example, consider the great struggle to make progress in realizing the intent of the Emancipation Proclamation in the United States following its passage.  One of history’s main lessons, in these examples, is that simply passing laws does not guarantee immediate change in culture and behavior.  We contend that history’s lesson is one of perseverance until change for the better is realized.  We must persevere to correct our current bureaucratic and corporate problems.  Therefore, we believe that changing the US FDA’s broken FDA regulatory system will take time. 

So far, those in oversight positions have authorized studies and reports that identify problems at the US FDA and repeat the urgent need for improvement.  (For example, Institute of Medicine (IOM 2006), Breckinridge Institute 2006, Subcommittee to the FDA Science Board – 2007 and several Congressional oversight studies by GAO and IG to name a few.)  Laws and policies have been drafted by our legislative branch.  These are the first steps. 

Thoreau-FDA.com asserts that the next step is the acknowledgement and elimination of one of the main problems – professional oppression.  Thoreau-FDA.com endeavors to bring that problem into focus.  It is a particular inner cultural problem that is difficult to see from the outside.  And many on the inside of US FDA also cannot see it or refuse to see it.  Perhaps for these reasons it has neither been adequately acknowledged nor addressed.  Hence professional oppression malingers at FDA, since there has been little or no attempt to rectify the causative inner cultural problems.  But these problems must be faced so that everyone in the present and future global community has the safest and best food and drugs that can be provided to them. 

As we look back, the first pages in chapters of our history were prepared by those who preceded us, such as Thoreau, King, Gandhi, Kelsey, Stanton and many others who recognized injustices and sacrificed to make changes.  What about those who follow us?  How can we help our children’s children write their history?  Shall we prepare the first pages for their pens?