MPNforum Magazine

“Before the Law stands a doorkeeper. A man from the country comes to this doorkeeper and asks to be admitted to the Law. But the doorkeeper informs him that he cannot grant him admittance at this time.”

Thus begins Before the Law, one of Franz Kafka’s classic short stories.

What brings this mind is the process through which drug companies and the federal bureaucracy collude to bar access to the most elemental information.

C.O.Bartning, 1954

In mid-November, 2013, when Sanofi, seemingly out of the blue,unceremoniously cancelled its clinical trial of a myelofibrosis drug, we thought some explanation would be forthcoming. It was.  A corporate statement about Wernicke-encephalopthy- like symptoms, risk to the patients not worth the benefits, yada yada.

There were so many unanswered questions that, after hitting a blank wall with Sanofi representatives we came to the door of the Law. We asked the FDA – which sanctioned the trial and had the ultimate power of oversight – what happened?

We were told we it couldn’t respond at this time. Regulations against divulging trade secrets and legal requirements to protect the confidentiality of Sponsors engaged in investigation of new drugs prohibited it.

We filed an appeal, protesting we had no interest in trade secrets and Sanofi had abandoned its IND as well as the enrolled patients and thus no longer enjoyed the protection of confidentiality.

The Doorkeeper informed us he could not grant us admittance at this time.

We followed with e-mails, phone calls and letters. Finally a representative of the Law,  from  the Program Support Center — an administrative agency of the FDA within the Health and Human Services Department — peered out from an office way down the hall, just visible beyond the Doorkeeper. She shouted: “We’re very busy. Maybe in three months we can grant you admittance.  Legal review is very time-consuming.” And she disappeared.

In Kafka’s story, the man from the country took a seat and waited, periodically asking for entrance to the Law. He ages, his vision dims, he dies. He never gains access to the Law.

Because we didn’t take a seat but went out into the world to collar employees of Sanofi,  listen to the whispers of physicians, the complaints of patients, the murmurs of insiders we gradually pieced together a story of missed opportunity, bungled medical reporting, incompetence and courage.

No one comes off looking good, but we found no outright villains, just shoddy oversight,  heavy handed, slow moving bureaucrats and corporate administrators who did not know what they were seeing and did not connect the dots. Our report on that investigationis here in this issue.  It’s not the view from the heights of the Law because we are still denied access to the documents that would confirm or deny the version we cobbled together.

So this appeal is not to the Doorkeeper of the Law but to my fellow patients.

Our bodies and our lives were on the line in that Sanofi  trial. We were the ones failed by corporate and government over-seers. Now it is the arrogance of powerful corporate and bureaucratic forces rejecting our right even to know what took place that calls me to ask for your help.

Morally, we have a right to know. Legally,  Congress in the Freedom of Information Actm 5 U.S.C. § 552 and the FDA’s own regulations spell out these rights.  The FDA is violating the Law by refusing even to deny our justified appeal of the denial. It simply forwarded it on to PSC-FOIA to be further delayed despite the crystal clear requirement that we be advised of its decision within 20 days following filing of our appeal.  It has been three months since we first approached the Doorkeeper and 54 days since we filed our appeal

Let’s walk through that door with the help of some powerful friends.   

This is election season.  We all have computers. And those of us in the US, have Congressional representatives We can easily contact our representatives. Her or his name and contact information are here   Say whatever you will, long or short in your e-mail.  But do cut and paste this reference to our MPN patient appeal in your e-mail :   FOIA appeal PSC/FOIA-14-0206  filed February 24 and request they intervene to make PSC-FDA-FOIA comply with the Freedom of Information Act and release documents. That outcome  might finally lay this matter to rest… and grant MPN patients some measure of reality and help us rebuild  confidence in the clinical trial system.

Access to information that affects our lives and the lives of our loved ones has no business being locked away in the dark. It is well worth the trouble of an e-mail. A victory for MPN patients seeking to bring vital information out of the shadows into the sunshine will serve all patients facing the unlimited power of business and government.

Or, we can pull up a chair and sit at the feet of the Doorkeeper, hoping for access to the Law.

(The final Kafakesque aspect of all this is the FDA really wants patients to do this, to Speak up, Ask questions Find facts… they call it the SAFER program. Honestly, some things you just can’t make up. )

–Zhen 

You can find your representative by  entering your zip code or street address: http://www.house.gov/representatives/find/

http://www.contactingthecongress.org/

http://www.senate.gov/reference/common/faq/How_to_contact_senators.htm

Take me back to the Contents

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