International MPN News, Science & Opinion

FDA and the Banana Republic for Which It Stands

 

Most of us have little appetite for long descriptions. And unless we’re caught up in some legal tangle, going through convoluted documents with endless references to other weird documents and citations is like diving into a sea of nettles. You have to get through it to survive…but it’s not going to be pleasant.

I wonder if the Boston colonialists felt the same way reading the King’s law on the new Tea Tax?  Probably not. We’ve gotten a lot more shifty and sophisticated about writing and evading the law.  Take the FDA.  Our own US Food and Drug Admistration.

Once they refuse to release documents under the Freedom of Information Act, there’s a clear obligation for them to respond to appeals in 20 DAYS.  (It used to be 10 days but then they sought and got an amendment.)

MPNforum requested FDA documents re its role in the Sanofi Fedratinib clinical trial blowup in January.  We were turned down based on “Trade Secrets” limitations and the prohibition against releasing information on active independent new drug investigations (INDs).

We filed a new appealed (see full appeal here) on February 24 confident of a speedy judgment. We wanted to know why MPN patients died and were injured by an investigative drug without apparent awareness or appropriate reporting in an FDA sanctioned Clinical Trial.   We have no interest in  trade secrets. And, more importantly, the FDA was no longer prevented from against divulging IND confidential information.  Sanofi abandoned its IND for Federatinib both through public announcement and direct, formal letter to the FDA.  We attached a copy of the corporate press release to our appeal.

No answer.

We called and we e-mailed.

March 25, we emailed FDA FOIA

Re: FOIA appeal PSC/FOIA-14-0206  filed February 24

Might I have a response to my March 25 e-mail, below?

While our appeal was submitted February 24, MPNforum Magazine and MPN patients have been  applying to the FDA FOIA for release of this information since January 7.  Could we get a progress report or some estimated time we might expect your decision on granting our appeal?

Thank you,

Zhenya Senyak, Editor

No response.

 

 

 

 Is it possible to contract out democracy?

 

Status: FOIA appeal PSC/FOIA-14-0206 filed February 24

From: Zhenya Senyak [mailto:zhenyasenyak@gmail.com] 
Sent: Friday, February 07, 2014 12:02 PM
To: Lee, Elizabeth J. (FDA)
Subject: FOIA Appeal
Hi, Elizabeth… Attached is my appeal of the FDA FOIA office denial of my request for documents.
Could you review it and let me know if I need to provide additional information?  Can I file this via e-mail or does it need to be mailed?
   Hope you’re well…Many thanks for your help,
              Zhen

Zhenya Senyak <zhenyasenyak@gmail.com>

Apr 8
to PSC

Good morning…

Re: FOIA appeal PSC/FOIA-14-0206  filed February 24

Might I have a response to my March 25 e-mail, below?

While our appeal was submitted February 24, MPNforum Magazine and MPN patients have been  applying to the FDA FOIA for release of this information since January 7.  Could we get a progress report or some estimated time we might expect your decision on granting our appeal?

Thank you,

Zhenya Senyak, Editor

MPNforum Magazine

=========================================================

April 8 we received an e-mail from Katherine Uhl of PSC”

PSC FOIA Request

Apr 8
to me

Mr. Senyak,

We are reviewing you appeal, there are several channels for review before a final determination is made.    I would estimate a response within three months but that depends on how long our legal team takes to do the review.

Katherine

 

 

Zhenya Senyak zhenyasenyak@gmail.com

Mar 25
to PSC  (Katherine UHL)

Thank you, Katherine…  Delay in response in this case is equivalent to denial since many patients are awaiting information on the reporting of SAEs in the Sanofi fedratinib trial.

With last week’s clinical hold placed on Geron’s Imetelstat clinical trials — also with no disclosure to patients or healthcare providers — affecting the same blood cancer patients shaken by Sanofi’s sudden  termination of a late Phase III trial, there is understandable uncertainty and fear of vulnerabilities in our patient community.

Can you give me any estimate of when we might expect a response to our appeal?

Thank you,

Zhenya Senyak, Editor

MPNforum Magazine

PSC FOIA Request

Apr 8
to me

Mr. Senyak,

We are reviewing you appeal, there are several channels for review before a final determination is made.    I would estimate a response within three months but that depends on how long our legal team takes to do the review.

Katherine

 

From: Zhenya Senyak [mailto:zhenyasenyak@gmail.comSent: Tuesday, April 08, 2014 9:08 AM To: PSC FOIA Request Subject: Status: FOIA appeal PSC/FOIA-14-0206 filed February 24

Zhenya Senyak <zhenyasenyak@gmail.com>

Apr 8
PSC

Katherine, that is unacceptable.

An agency is required to make a “determination” on the merits of a FOIA appeal within 20 working days of receipt. 5 U.S.C. § 552(a)(6)(A)(ii).     It has now been 45 days since we filed this appeal.

We are willing to work with the FDA to get information that should clearly be in the public domain now that the Trial Sponsor has withdrawn from further development of its IND.  These documents need to be understood by a vulnerable patient population  whose health and well-being is at risk in the absence of clear evidence that working safeguards are in place in FDA sanctioned clinical trials..

The practical impact of your response denies us a reasonable expectation of getting the requested materials at the administrative level and delays our efforts to seek judicial review of the FDA’s refusal to grant our request.

Respectfully,

Zhenya Senyak

=============

 

So what’s PSC/FOIA?  (Program Support Center)

The PSC is a federal entity that provides products and services on a competitive “fee-for-service” basis. The PSC was established in 1995 as the first true shared services enterprise within the Department of Health & Human Services (HHS). It was originally created to support HHS and has since expanded its services to 31 other federal agenciesRead more >

 

he Freedom of Information Act
5 U.S.C. § 552, As Amended By
Public Law No. 104-231, 110 Stat. 3048

http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm  (The full Act with amendments).

The clause violated by the FDA and the PSC

(6)(A) Each agency, upon any request for records made under paragraph (1), (2), or (3) of this subsection, shall–

(i) determine within ten days twenty days (excepting Saturdays, Sundays, and legal public holidays) after the receipt of any such request whether to comply with such request and shall immediately notify the person making such request of such determination and the reasons therefor, and of the right of such person to appeal to the head of the agency any adverse determination; and

(ii) make a determination with respect to any appeal within twenty days (excepting Saturdays, Sundays, and legal public holidays) after the receipt of such appeal. If on appeal the denial of the request for records is in whole or in part upheld, the agency shall notify the person making such request of the provisions for judicial review of that determination under paragraph (4) of this subsection.

This material is FOIA and LETERS TO REPS>>>

We filed a formal Freedom of Information Act(FOIA) request.

Our request was refused based on “trade secrets” restrictions.

We appealed the decline.  And now, five months after the deadly event, the FDA FOIA office  has not yet ruled on our appeal even though its own regulations and FOIA law require a response within 20  days.

================================

MPNforum persisted through e-mails and phone calls and were advised by Kathelln Oh, ssss,  essentially, that the FDA is busy and we’ll get to it when we can, probably in about three months.

 

Your congresttonal repreasettioves can be reached HERE:

Please do it today.  These are not petty issues but basic human rights written into the Constitutuion, law and Federal regulation.

Use it or lose it has never been clearer. If we can’t rise up and demand our constitutuional, moral and legal right to know what the hell happened, corporate executives and government bureaucrats will simply continue to trample on those rights,

 The story behind this deadly series of events needs to be brought into the sunshine. Until then, we will live perpetually in the shadows of secrecy.   That means we enter clinical trials in ignorance.

That means accepting failure of the safety systems built into clinical trials.

That mean compounding our risks and the risks of our friends and loved ones who offer their bodies to science and coproate  profit in an atmosphere of secrecy and hidden …

Like a petty despot, the FDA is arbitrarily violating its own regulations In refusing and then delaying release documents requested under the Freedom of Information Act,

These documehnt affect the core interests are all MPN patients andt heir caregivers and physicians

This refusal violates US citizen’s rights to know under FOIA and the rights of a free press to obtain and publish information in the public interest.

If we cannot forcibly protest these actions by writing our representatives – who will be up for election in six months! —  and demanding implementation of our rights, we might as well give in to a the encroaching bureaucratic oligarchy that smothers democratic processes.

 

 

AttachedL Our full appeal

 

 

 

 

freedom of press (wp transparency report)

 

Welcome to the Shadowland.

The bombshell dropped just as we were packing to head out to ASH in New Orleans in November, 2013.   Almost six months ago.

Days before filing for final FDA approval after its massive worldwide Phase III JAKARTA trial of Fedratinib, the French drug giant Sanofi dropped the bomb. The leading contender to unseat Incyte’s Jakafi in the JAK2 inhibitor derby, pulled out of the race without warning.

Patients were left in the lurch, with instructions to see their doctors.  Principal investigators running the trial were as much in the dark as the rest of us.

The MPN world was, briefly, in shock.

 

What happened leading up to this brutally sudden ending of a trial so many depended on and what happened in subsequent months is critically important to every MPN patient, caregiver and physician.  The exposure of raw corporate and bureaucratic power to throttle information that would inform our decision-making can never again be doubted.

 

MPNforum took the lead in reporting this story (LINK). It’s worth revisiting our first story. It’s not bragging. It’s simply true.  Myeloproliferative neoplasms are such a small part of hematology that it’s not surprising medical media barely registered the story.  And unlike commercial MPN institutions, some support groups and events organizers,  MPNforum takes no money from drug companies and is free from reporting constraints.

 

Over the next weeks, after announcement

FDA and the Banana Republic for Which It Stands

 

 

This part is for our American readers. Our international friends –  a very substantial  sector of MPNforum – are most welcome to listen in and participate in discussion butonly American citizens can take direct action.

Bring in the heavy hitters.  Write your Congressman. It’s five short months to mid-term elections, they will listen!.  A short e-mail in any words you choose but please include this informration. FDA request by MPNforum #eeeee.. Appeal dated DDDD not far beyodt eh 20 days required responed date.

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

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