PRNs' Director Siobhan Reynolds Speaking Before the FDA's Advisory Panel 9/9

I'm Siobhan Reynolds, Executive Director of Pain Relief Network in New York. We have no financial relationships with any pharmaceutical companies of any kind. We are a national patient and physician advocacy group dedicated to making pain care available to Americans. I'd like to tell, you, if I might, how I came to stand before you today.

I married a man, Sean Greenwood, who developed severe chronic pain as a result of a congenital connective tissue disorder. We were married for eleven and a half years, we had a son, and I continue to care for him. As a result of the damage he and our family suffered because we were unable to find pain care, I became an advocate on behalf of all Americans in pain. I became familiar with the inner circle of cutting edge pain care and was invited to participate in an Internet listserve discussion on the issues confronting physicians who treat pain.

One by one, I watched as several of our most prominent members were arrested and charged with murder, or subjected to accusations of violating the Controlled Substances Act. I knew, as I watched, that something was going terribly wrong. I am trained as a filmmaker so I set out with my camera to find out what the stories were behind the attacks. What I found will soon be a film, but what I found also brought me before you today.

In my travels, I came upon Dr. Deborah Bordeaux, as she was about to stand trial in South Carolina, for writing prescriptions for pain medications outside the course of professional practice and without legitimate medical purpose. I sat along side her and two other doctors tried on similar charges.

I was shocked and dismayed to learn that the Justice Department was bringing out of date, antiscientific, prejudicial testimony into a US courtroom in the hopes of convincing the jury that by prescribing medication in conformity with the actual, up to date standard of care, the standard I was familiar with, that these doctors had done something shameful, something unspeakably wrong.

I have since watched the US bring such cases all around the country. In response, I began PRN and hired nationally renowned counsel to take up Dr. Bordeaux's appeal, partly because I wanted to save this innocent woman from federal prison, but also because I wanted to figure out what was going on here. How could it be, I asked, that an area of medicine so central to the physician's role, that of relieving suffering, could find itself so thoroughly overwhelmed, so unable to develop its practices in the community, as any other area of medicine is allowed to do?

As it turns out, the Red Flags that the Government uses to determine if a doctor appears to be diverting drugs, rather than practicing medicine are, for all intents and purposes, identical with the markers I or the health care professionals I know, would identify as signs that good progressive medicine is being practiced.

In other words what we have here is a perfect storm created by the collision of the development of progressive pain care with the application by Ashcroft's Justice Department of the now hopelessly out of date Rosen Rules. As a result, hundreds of physicians have been misidentified as being in violation of the Controlled Substances Act and have borne the brunt of Justice Department Drug prosecutions aided by determinant sentencing laws that have become so draconian that Supreme Court Justices' Renhquist and Kennedy have been moved to speak out against them.

Physicians all over America have been induced to take plea deals or to walk away from medicine all together, rather than face what Dr. Bordeaux currently faces.

Having been convicted by a lay jury of violating the CSA, Dr. Bordeaux's Oxycontin prescriptions, 270 pills in total, were weighed up as though they were heroin. The probation department has recommended that Dr. Bordeaux serve 100 years in prison.

Since this committee cannot be moving to further manage the risk of Paladone as a result of objective evidence of harm, because the only evidence we have disproves the DOJ's claims of "hundreds of deaths" summarily. And you cannot be concerned on the basis of any finding by any court that Purdue Pharma has been negligent, because they have beaten all such claims against them, without exception. I must conclude, therefore, that your perception of the risk posed by Paladone is created at least in large part by the astonishing increase in physician prosecutions recently reported by the Justice Department.

I'm here to tell you that a terrible misunderstanding has occurred here and that the public health has been inestimably damaged. All over America doctors have simply put down their pens, patients in pain have returned to their beds or committed suicide. The suffering and destruction of innocent life is unimaginable.

PRN is therefore calling on you to suspend your cooperation with the DOJ and to stand solely for your primary commitment to safeguard the public health. The public and the compassionate physicians have been badly let down by our Federal Government, a Federal Government which seems to have lost its way.

We hope you will join us in our call for an open and frank Congressional investigation into what has happened here, before you resume your collaboration with the Department of Justice.

The damage done will only come to be known, as we uncover the deaths and listen to the stories the American people have to tell.

You can find our website at

Thank you.
Siobhan Reynolds

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