Thoreau-FDA - the videos

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Link

Transcript - video 1.

What if you were asked to do something you knew was likely to make someone sick or dead – would it matter if that "someone" were a person you love, or a pet, or a total stranger on the far side of the world? –What if many people could be harmed by your actions?Now suppose your manager or boss asked or pressured you in a way that makes it look like the “something” was your own idea, not his or hers?

That is the situation faced by some Federal workers whose job it is to protect public health. Over the past few years, civil servants in the United States Food and Drug Administration (FDA) were pressured or verbally directed by higher-up managers to "recommend" approving new drugs, "tone down" or ignore signs of health dangers, and disregard track records of defective manufacturing safeguards. These instructions are known as undocumented top down approve directives. We don’t know how many occurred since the mid- 1990’s -- mainly because they are verbal and go unwritten. Recent headlines about terribly defective and dangerous, yet approved, products can be the result of these flawed drug review processes that I am talking about.

Now, you're probably thinking that the FDA must certainly have administration wide policies to prevent this kind of drug application review abuse by US FDA managers. The fact is, such life saving policies have neither been instituted nor announced. As a starting point toward needed reforms, you can send a letter to US FDA Commissioner Von Eschenbach, urging him to reform the review process and bring a swift and sure end to dangerous practices in the drug review system. The letter also requests Commissioner Von Eschenbach to answer questions about his “Values and Vision” effort to stop professional oppression by US FDA managers. Commissioner Von Eschenbach, the first of several questions over the coming weeks to you is:

“How does your Values and Vision effort, as initially announced to US FDA staff in the September 19, 2007 web cast and subsequent March 2008 updates, prevent future undocumented top-down approved directives and more retaliation against US FDA staff who publicly expose deadly human and veterinary products?”

Thoreau-FDA.org presents a letter you can review, edit, sign and send to halt top down pre-determined outcomes and to stop FDA management retaliation against US FDA staff who try to do their job and protect the public health. That is why I am in the shadows, but these practices can no longer be in the shadows. In the coming weeks, we will ask more questions of Dr. Von Eschenbach with the goal of ensuring actions that secure the US and global public health safety. Please, take the first step in protecting public health and keeping harmful products off the market. Urge the US FDA adopt proactive and meaningful drug review policies by signing and sending an email to Commissioner Von Eschenbach today.

Transcript - video 2

Hello, and welcome to Thoreau-FDA.com. Our web site, has been operating for about three weeks. This is our second video.

First, we thank all who have forwarded our web site letter to our US FDA Commissioner. Our records show 20 copies, including one from another country, have been sent to his e-mail address. The end of the letter poses a question which I will ask again at the end of this video.
Commissioner Von Eschenbach, we and the citizens of the United States and now one citizen from another country, are awaiting your response. Thank you in advance for your answer. Your answer will maximize the effectiveness of your Values and Vision program and optimally, ensure that safe and effective medical products reach people in this and other countries, a goal we know you want to achieve.

Second, we thank our fellow citizens who alerted us to medical products that have reached the marketplace and caused harm, loss of life, wasteful litigation and lost time and money in our court system. These dangerous products already have had extensive media coverage. We in Thoreau-fda.com want to ensure that, in the future, such products never reach the US or global market. Or, if such products, do, that they are marketed with the truth of fully disclosed warnings that have passed through a valid and transparent pre-approval process with traceable accountability to all decision makers. And a first step to block more dangerous deadly products from the market or to ensure adequate label warnings is the receipt of an answer from Commissioner Von Eschenbach to our question.

Third, we have received quite a few comments and some blogs. We are considering posting these at a future date when we open FDA-blog.com for all to see. One comment asks that we address the public’s need to be forewarned of dangerous deadly products, indeed the responsibility and job of the US FDA. Thoreau-FDA finds it difficult to fulfill this need at this time, due to our extremely limited resources, small group size, and our often adversarial position against US FDA upper managers, who cut us out of information networks in the agency. Indeed, the Ordeals hyperlink on the Thoreau-fda web site, presents evidence that US FDA staff have been side lined and ostracized for doing the US FDA’s job of publicly exposing harmful or deadly products. We want to ensure Commissioner Von Eschenbach stops this abuse of US FDA staff who do their jobs. And, if we should become aware of deadly or harmful products, we will make them public, after confirmation .

I now restate the goal of Thoreau-fda, in different words than those stated in the web site’s Purpose and Goals. We of Thoreau-fda work to eventually eliminate the need for the public to be forewarned of dangerous products by ensuring the US FDA’s review process prevents such products from ever reaching the market place or that they enter the market with labeling that discloses full warning, when appropriate, of side effects or adverse reactions found in clinical trials. These changes will take time. And as a first step, we ask our fellow citizens to forward the Letter on our site to the US FDA Commissioner.

Finally, to all the reporters who have asked for an interview and story. Please be patient. In the meantime, the current story is – People are waiting. Will the US FDA Commissioner answer the question that has been forwarded to him by nineteen of our fellow citizens and one fellow global citizen from another country? Or will he leave it for the next US FDA Commissioner to answer ? Again, Commissioner Von Eschenbach, the question is -

"How does your Values and Vision effort, as initially announced to US FDA staff in the September 19, 2007 Webcast and subsequent March 2008 updates, prevent future Undocumented Top Down Approve Directives or Requests, and more retaliation against US FDA staff who publicly expose deadly human and veterinary products?"
Hat tip: http://sstrumello.blogspot.com/