Will Stanislaw Burzynski slither away from justice again?

Dear FDA Representative (Lena): Re: Your unsatisfactory, inadequate response ...

to my inquires and concerns.

Firstly, my apologies as for some reason I did not receive you voicemail on my home phone where there
are several family members accessing it but especially my cell phone. As to why in this specific instance
I chalk it up to coincidence.

That said, I will try to bluntly convey to you in this post what I would if you were sitting here before me
or at the other end of a telephone line.

Perhaps it is better in this written format as there is really no ambiguity of what was said or referenced
by either of us in conversation. There is a solid accurate archive exactly what was discussed. However
if there is a question or ambiguity it is much easier to resolve by voice and then easier in person with all
the inherent visual cues.

Please note before I continue I will be CAPITALIZING some words to make succinct points and
clarifications. I promise I be discrete about my usage in this regard.

In re-reading my note (E-mail) to you and then your reply immediately attached below and then having my
daughter; a very intelligent, able 7th grader read it as well, she nor I interpreted my verbiage to imply you
(the FDA) gave approval/clearance of Dr. Burzynski's Antineoplaston therapy.

Again, you did give Dr. Burzynski the CLEARANCE TO PERFORM PHASE III TRIALS which is inherently different than approving the drug itself. I think this distinction should be apparent to the casual reader, but what I hoped was especially yourself.

However that said in providing Dr. Burzynski clearance to perform Phase III trials, you (the FDA) inherently, by default or by mandate:

1.) Logically Antineoplaston therapy must have SOME measure or modicum of substance and veracity however minute that has to be sufficiently to warrant putting people's health and safety at stake even though already compromised by cancer. There must some indications.

2.) Directly related to 1.), you (the FDA) must show confidence in the experimental trial sponsor having cleared the Phase I and Phase II veracity/validity/viability tests or gates (in this case Dr. Burzynski) that they possess all the credentials and in simplified terms an adequate "game plan", track history and protections in place to protect the health and welfare of the volunteers or test subjects for his trials; especially if their health is already compromised by cancer or some associated disease or condition with respect to it e,g. previous treatments, medications etc.

3.) The FDA is not going to permit a given experimental drug trial sponsor to continually offer the treatment using the drug to the public yet never completing all the Phase trials, thus of course never getting the drug approved and demonstrating no intention of completing the trials.

In these three aspects with respect to Dr. Burzynski, you (the FDA) have failed miserably and in doing so
I cannot stress strongly enough you are putting my life yours, society and even the world in direct and
indirect danger.

Lena (I don't know your last name, you've never related it to me), you feign ignorance of your own agency's legal proceedings against Dr. Burzynski, you will not admit and with respect to the Texas Medical Board (TMB); all you need do are a few Google searches and you won't even acknowledge anything of the FDA renouncing Dr. Burzynski's treatments and he's been determined by them to be a threat to the public. on from what I understand are on relatively the same grounds as the FDA has. All you do is refer me to the TMB.

http://casewatch.org/board/med/burzynski/complaint_2010.shtml

Of the three aspects I just listed of oversight concerns I trust; and truly hope the FDA takes into
consideration, I rank # 2.) the most important. Where experimental drugs are inherently dangerous
having the side or direct effect potential to make the test subjects considerably sicker with even
lethal consequences.

Thus it goes without saying this is a heavy responsibility borne by the experimental drug sponsor
as well the regulatory agency i.e. you (the FDA). I hope you'll agree the level of oversight, integrity,
public transparency, consistency and following a course where the safety and heath of the public
is a constant concern and consideration of your agency should rise to higher standards than the crux
of those that are purely financial in nature.

Perhaps you've heard the recent news about the congressional hearings trying to get to the bottom
of the million dollar luxurious trips to Las Vegas and exotic locations such as South Pacific islands and
Hawaii by high ranking officials of the General Services Administration (GSA) essentially partying
at taxpayer expense. It's been all over the news:

http://en.wikipedia.org/wiki/General_Services_Administration

Or, perhaps when visiting Florida you had the opportunity to go through a condo time-sharing
"seminar" experience where so many green, naive tourists are hoodwinked into buying something
the vast majority regrets. There is a Florida state regulatory agency that oversees [sic] all the
timeshare sales operations essentially permitting outright deceit and bait and switching at every
juncture. Obviously, time-sharing is a great revenue generator for the state of Florida reaping
the benefit of colluding with some of the slickest sales(wo)men on earth preying on sun and
warmth starved Northerners.

These are two instances I've just mentioned if you think about it are "only" about money. The
FDA is different ... MUCH different. I'm sure you can understand and appreciate what I'm trying
to convey here.

Again with respect to # 2.), on October 5, 2009 your Dr. Prohaska, Acting Human Subjects
Protections Team Lead in your Division of Scientific Investigations, Office of Compliance, Center
for Drug Evaluation and Research sent Dr. Burzynski / Dr. Burzynski's Institutional Review
Board (IRB) a stern "warning letter" re: whether the IRB procedures for the protection of human
subjects complied with Title 21 of the Code of Federal Regulations (CFR), Parts 50 and 56 and
other deficiencies: "Within fifteen (15) working days of your receipt of this letter, you should notify
this office in writing of the actions you have taken or will be taking to prevent similar violations in
the future. Your response should include an update on the status of the (b)(4) and (b)(4) studies.
Failure to adequately and promptly explain the violations noted above may result in regulatory
action without further notice:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm192711.htm

Through intensive Internet searching I could find no letter or statement by the FDA and/or Dr.
Prohaska that Dr. Burzynski / the Burzynski IRB adequately and/or sufficiently complied with
the warning letter's stipulations and criteria. Rather, I received a response from Dr. Prohaska I
could submit a Freedom of Information Act (FOIA or FOIL) request.

I take this as a ruse by Dr. Prohaska to hinder and stifle my efforts to get a definitive answer of
what should be an easily crafted reply. With a more than passing familiarity with FOIA/FOIL
requests I know that it is paramount to know the exact title or some kind of official identifier
that explicitly references the given document. For example the formal reference identifier number
or code for Dr. Prohaska's warning letter is: 10-HFD-45-09-01.

From my experience and I trust Dr. Prohaska is aware a generic request such as "warning letter
to Dr. Burzynski" can be easily and "conveniently" deemed to vague and broad easily circumventing
the spirit and intent of the FOIA act.

However there are clues that Dr. Burzynski indeed did not comply with Dr. Prohaska's warning letter
and I am certainly not the only one who has brought the FDA's egregious lapse of their proper oversight
to their attention. You can deduce this letter was sent to the FDA a mere five months ago or so from
"Majikthyse" to: Dr. Constance Lewin, M.D., M.P.H., Branch Chief, Good Clinical Practice Branch I
Division of Scientific Investigations Office of Compliance Center for Drug Evaluation and Research
Food and Drug Administration:

http://majikthyse.wordpress.com/2011/11/30/ask-the-fda-to-inspect-burzy…

It is a marvelous corroboration of many of my points I've discussed and conveyed where if I have failed
perhaps "Majikthyse" will succeed. I will be copying (cc:ing) Dr. Lewin in on this note/document.

In the interim between 10/05/2009 and 11/30/2011, 12/13/2010 to be exact, the FDA gave Dr. Burzynski
clearance to perform Phase III trials of his Antineoplaston treatment relayed to me a reference from a
source I want to emphasize was APART FROM THE FDA!:

http://clinicaltrials.gov/ct2/show/NCT01260103?term=burzynski&rank=61

By all rights this information this information should have been relayed to me which appears to be public
information and nothing proprietary but you Lena or your any of your associates including the names of
just who signed off on the clearance.

That you (the FDA) should have granted Dr. Burzynski Phase III trial clearance is very questionable in its
own right. Considering you the "U.S. government; no agency of it has stated Antineoplastons have any
semblance of effectiveness to warrant Phase III trials:

http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/patient/page1

http://www.cancer.org/Treatment/TreatmentsandSideEffects/Complementarya…

Here are the experimental drug Phase definitions directly from the U.S. Government:

http://clinicaltrials.gov/ct2/info/understand
http://clinicaltrials.gov/ct2/info/glossary#phaselll

PHASE 1 TRIALS: Initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.

PHASE 2 TRIALS: Controlled clinical studies conducted to evaluate the effectiveness of the drug for a
particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks.

PHASE 3 TRIALS: Expanded controlled and uncontrolled trials after preliminary evidence suggesting
effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling.

PHASE 4 TRIALS: Post-marketing studies to delineate additional information including the drug's risks,
benefits, and optimal use.

For several years up to the present, Dr. Burzynski has been wallowing in "perhaps Phase II" status with
seemingly no intention of conducting Phase III trials all the while holding himself out to the not only
the United States but the world for general treatment of cancer using Antineoplastons that has not been
approved for the prevention and treatment of ANY DISEASE by you the (the FDA) under your lax
oversight.

In closing Lena, I have brought to your, and thus by extension the FDA's attention that Dr. Burzynski
holds himself out to the public for general treatment of cancer using Antineoplastons. Desperate people
hold funding drives that they may be treated by him and to add to the confusion it appears the U.S.
government has taken out patents in what it purports to be figuratively speaking fallow grounds:

http://www.burzynskimovie.com/index.php?option=com_content&view=article…

That money could be used for any medicine or treatment that where perhaps less effective than what
Dr. Burzynski purposts, is nowhere near so tainted a history, controversial and contradictions abound.

I vehemently contend the contradictions and paradoxes I've tried my utmost to succinctly articulate
warrant an unambiguous honest response from you (the FDA) if you are going to allow Dr.
Burzynski to continue to operate as he has status quo and if yes could you clarify on what grounds?

Again I'm copying in (cc;ing) my congressman Tom Reed on this thoroughly egregious lapse by you
(the FDA) in protecting the health, welfare and safety of of all Americans. Rep. Reed has shown an
interest in cancer:

http://www.youtube.com/watch?v=T4oWLfZg6I8 (titled: Congressman Tom Reed Supports Cancer
Mission 2020)

http://www.cancermission2020.com/cancersummits.html

I'm also copying in (cc:ing) Warren Buffett who perhaps from news reports you know has recently
come down with prostate cancer. Perhaps with his vast financial resources and political clout he might
have similar inclination to get to the bottom of this dangerous mass of confusion and contradiction
and have better luck succeeding where I fail. It's now personal issue by him too.

Thank you for your prompt reply to my request. I welcome and look forward to your correspondence.

Sincerely,

Joel Shapiro

Hello All,

On 11/30/2011 "Majikthyse" who I perceive is from England sent a letter to FDA Good Practical Branch Chief Dr. Constance Lewin a "What the hell is going on with the FDA???" inquiry letter. Being from England he probably has less standing than an American citizen to get (a) response(s) from them but the FDA's long track history of deflection and obfuscatioin and ducking the issue with bureaucratic dribble (OK let's call it is: Bullshit) and other tactics, it really doesn't make much of a difference. Perhaps what does make a difference is as an American citizen in good standing and still alive lest my cancer takes me down which it ultimately probably will, I can suibmit a FOIA request letter. Here is the first of perhaps many (?) FOIA requests that I hope will bring some clarity to the issue to the Burzynski issue; at least who did (not) do what when. Hopefully "Majikthyse" if you see this I hope I've done you proud. Joel S.

http://majikthyse.wordpress.com/2011/11/30/ask-the-fda-to-inspect-burzy…

U.S. Food and Drug Administration (FDA) FOIA Officer Darshini Satchi
U.S. Food and Drug Administration (FDA)
10001 New Hampshire Avenue
HILL-3111
Silver Spring, MD, 20993-0002
Re: Freedom of Information Act Request
Wednesday, April 25, 2012

Dear Darshini Satchi / FDA FOIA Officer

This is a request under the Freedom of Information Act.

I request that a copy of the following document concerning the following subject matter be provided to me:

The notification letter to the Burzynski Research Institute (BRI) Institutional Review Board (IRB) that certifies and/or acknowledges that it has adequately and sufficiently rectified and/or addressed all the criteria and stipulations of the October 5, 2009 FDA Warning Letter composed or written by Dr. Kevin A. Prohaska, Acting Human Subjects Team Lead, Division of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration where he categorically cited the deficiencies of the BRI IRB procedures for the protection of human subjects.

The FDA Reference code for this document is Ref: 10-HFD-45-09-01

Here is the link to the document itself posted to the public at large on the FDA web site:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm192711.htm

In order to help to determine my status for purposes of determining the applicability of any fees, you should know that I am an individual seeking information for personal use and not for a commercial use.

I request a waiver of all fees for this request. Disclosure of the requested information to me is in the public interest because it is likely to contribute significantly to public understanding of the operations or activities of the government and is not primarily in my commercial interest. I intend to post the full notification letter verbatim on the Internet as well as any additional commentary, if any, provided with respect to it by the FDA.

I request that the information I seek be provided in electronic format, and I would like to receive it on a personal computer disk or a CD-ROM. If this is not possible a standard paper document will suffice.

I ask that my request receive expedited processing because it will immensely contribute to my ability to evaluate and consider viable cancer treatment options that are the foundation of some of the most important decisions of my life. Furthermore the feedback and opinions from the public will only serve to enhance my study and evaluations thus my compelling reason to disseminate the results of my request to the public at large.

I also include a telephone number at which I can be contacted during the hours of 10AM to 10 PM EST/EDT Monday through Sunday, if necessary, to discuss any aspect of my request.

Thank you for your consideration of this request.

Sincerely,

Joel Shapiro
119 Schilling Lane
Rochester, NY, 14618
Phone numbers in order of preference:
(585) 255-0997 (Cell)
(585) 473-7013
(585) 250-8053