“The Amazing Meeting” (I don’t think it means, what you think it says it means): 2 Intellectually and Ethically Challenged Individuals, Twaddle at TAM 2013

Gentlemen, I start your Insolence 😇
(1:30) [1]
The “motto” of “The Amazing (Not so Much) Meeting” is “Fighting Fakers,” which is apropos, since I doubt that “Orac” the “Check my Facts” Hack of Dr. David H. Gorski, grasps the irony, that when I read some of his blog articles, you could easily switch his name with the name of some individual he is flogging, and the proverbial shoe fits, and:
“This is a guy who sometimes fools even, you know, physicians”
(I couldn’t have said it better, myself) 😊
He states:

“There is a long segment about “The Skeptics”

(applause) 😝
“His lawyer wrote a book”

“About a half of it is about Burzynski [4]
Gorski mentions that Burzynski noticed that there were higher levels of these chemicals in healthy people, than people with cancer
Whereas, Burzynski is on record as having said [5]:

” . . . healthy people have abundance of these chemicals in blood
Cancer patients have varied to none

I did NOT know before now, that GorskGeek thinks that “none” is a “level” 😶
He continues:

AS2.1 – which is a chemical called phenylacetic acid, which is a byproduct of metabolism that turns into phenylacetylglutamine by the liver

A10 – soluble is basically the same thing
It breaks down to PAG

I thought it was: AS2 1 😊

They are “basically the same thing” ? 😳

What does Burzynski say ? [6]

Phenylacetylglutaminate (PG) and Phenylacetate (PN) are metabolites of Phenylbutyrate (PB) and are constituents of antineoplaston AS2-1

PG and PN are naturally occurring in human body as result of metabolism of phenylalanine in liver and kidneys

formulation of antineoplaston AS2-1 is 4:1 mixture of synthetic PN and PG

A10 is 4:1 mixture of PG and iso-PG

That does NOT look like “basically the same thing” to me 😛

Gorski founders on:

“And these are substances which were actually studied in the ’50’s and ’60’s and not found to be particularly, um, promising, but, he didn’t know that then”
GorskGeek has #FAILED miserably to prove that on his blogs [7] 😄
Gorski comments about Burzynski’s “animal testing,” “species specific” claims:

“There are ways of getting around that”
But Gorski, again, has #FAILED miserably to prove it [8] 😅
Gorski makes lame excuses about the NCI phase II clinical trial [9] 😖
Gorski claims Burzynski was indicted for insurance fraud in the 1997 case 😱
GorskGeek, care to try and prove that one also ? [10] 😃
Gorski then states that out of 61 trials on clinicaltrials . gov, “most” are “closed or unknown”
GorskGeek #FAILED again 😁

At the time it was:

1 – Not Yet Recruiting
(OPEN)(Phase 3)
(Withdrawn due to slow enrollment)
(This study has been withdrawn prior to enrollment)
10 – Recruiting
40 – Active, not recruiting –
Gorski attempts to go all “legal eagle”:

“Listen to Burzynski’s lawyer!”

“You listen to Burzynski’s lawyer; and, and I swear I don’t understand, like why Burzynski would let him, let his lawyer say stuff this damning in his own book, but he does”

“So, get a load of some of these quotes, referring to one of the clinical trials, he says:”

“It was a joke”

“. . . there could not be any possibility of meaningful data coming out of the so-called clinical trial, it was all an artifice, that, you know, designed so that they could continue giving the treatment

“The FDA wanted all of his patients to be on an IND, so, that’s what we did”
Gorski, attorney Rick Jaffe is an American, living in America NOT the formerly communist Poland

He can say whatever he wants

GorskGeek is NOT a lawyer 😓

And there’s an excellent reason why

Nor is he schooled in the proper usage of the English language


” . . . the so-called clinical trial . . .”

Any human being with a modicum of intelligence about the English language, understands that the term “clinical trial” is singular, i.e. one

Burzynski’s lawyer is obviously referring to the CAN-1 clinical trial mentioned in Burzynski’s 11/25/1997 Securities and Exchange Commission (SEC) filing [11]

One trial that is retrospective is CAN-1 Clinical Trial


133 patients
Clinical trial of patients treated by Dr. Burzynski through 2/23/1996

FDA has indicated it will not accept data generated by this trial since it was not a wholly prospective one
Gorski continues his trend of #FAILURES when he mentions the additional types of treatments that Burzynski was offering, but he #FAILED to mention [12] 😂
” … in 1997, his medical practice was expanded to include traditional cancer treatment options such as chemotherapy, gene targeted therapy, immunotherapy and hormonal therapy in response to FDA requirements that cancer patients utilize more traditional cancer treatment options in order to be eligible to participate in the Company’s Antineoplaston clinical trials”
Gorski addresses the case of Tori Moreno
Kim Moreno states:

“We originally were at Miller’s Children at Long Beach Memorial and then went to City of Hope

“We also sent her MRI’s to Dr. Fred Epstein in New York to be looked at”

Gorski suggests that 3 different opinions could have misdiagnosed Tori Moreno

You can read an interview with Tori’s mother [13]
Gorski goes on to mention Burzynski patients going to Texas Children’s Hospital with hypernatremia issues
Gorski, do you mean this ? [14]

The changing pattern of hypernatremia in hospitalized children

Department of Pediatrics, Texas Children’s Hospital, Baylor College of Medicine, Houston, Texas, USA
Gorski mangles the case of Hannah Bradley, who had a grade 3 anaplastic astrocytoma brain tumor

GorskGeek makes excuses like “spontaneous remission”, but then provides no citation, reference, or link to a case of such a tumor having spontaneously exhibited remission [15]
Gorski states that antineoplastons are chemotherapy
No, Gorski, antineoplaston are:

“…an unapproved drug, not ordinary “chemotherapy [16] 😣
Gorski claims in regard to Burzynski’s personalized gene-targeted therapy:

” . . . gives to the patient without regard for synergistic toxicity

“Boom, there you go”
Gorski’s #FAIL rate continues, as Burzynski has stated that phase 2 and 3 publications are reviewed as part of this process [17]

Gorski, you should hire out to the Democratic Party as their mascot, because you must be the biggest pompous ASS I’ve ever seen 😜

Gorski, my advice: don’t quit your day job, HACK 😷
The #TAM2013 audience then has to suffer through 22:36 of the blatherskite of Robert J. (don’t call me Bobby) “Bob” Blaskiewicz Blatherskitewicz [2]

He blathers about the “dozen,” “17,” “16 dead,” “pancreatic cancer,” “Joseph, who was alive but died well within the life expectancy given his diagnosis,” “Joann, who was alive but died within a year of starting therapy,” “Irene S., who was dead within month,” “Maxine, who was already dead,” the “103 in 2011,” “63 in mid-June,” “17 on original 1999 site,” “about 3 added a year,” the “about 50 stories,” “1/10th of patient names gathered,” “Amelia S. – 7, tumor breaking up,” “Chase,” “Cody – 1994, 20 years ago, 2 visits, 6 weeks treatment breaking up,” “David,” “Janet, 3 – 5 yrs., oncologist, now dead, ovarian cancer,” “Pete took video down,” “8,000 patients,” “probable ischemic necrosis,” “13 yr. old, getting worse getting better, vomited – Marlene, nurse,” “Rory died 2005,” “Supatra, swelling, last wed., brain tumor,” “Side-effect, 2%, sodium load,” “Andrea, U.S. News and World Report, 30% chance recovery, glioblastoma, ANP in luggage, died on plane,” “Cathy wanted to be on ANP, Greg Burzynski, found out only brain tumor,” “Denise D. breast cancer,” and finally:
” … and light as many fires under his butt as we can
Mentions Rick Jaffe’s book Galileo’s Lawyer

All you need to know about Blaskiewicz is:

“White man speak with forked tongue” [18]
The 3rd video is a panel discussion, which includes “man-crush” tag-team [3]

Robert Blaskiewicz and David Gorski
Bob says:

“Yeah, I’m not that type of doctor
Bob, the correct answer for you, is:

“I’m NOT a doctor” QUACK
Gorski gabs that he’s a:

“Game of Thrones Geek”
I just knew I was right, GorskGeek [19]
The only female panelist mentions “bureaucrats”, “wimps”, and “people without balls”
2 out of 3 ain’t bad

She describes the Bob and David show to a T
The claim is made that a Burzynski physician appeared on the Burzynski Facebook page announcing results
Gorski #whines that the Texas Medical Board wasn’t successful in shutting Burzynski down because of “politics”
Gorski gives his usual excuse:

“He’s not an oncologist”
GorskiGeek, that claim is as dead as apparently, quite a number of your brain cells [15]
Audience members are given the opportunity to speak, and this is the garbage served up:
“Hi, this is Susan

Ah, don’t forget to mention that Wikipedia has been a major battlefield

We’ve had 23,000 views to the clinic’s page this last month, also rebutr . . .”
“Control the flow of information”
Gorski pipes up:

“What she said”
Blatherskitewicz chimes in:

“When it comes to Wikipedia can I just mention that is, that is, that that is so effective that Wikipedia was singled out in the most recent Burzynski movie
Gorski chirps:

Bob yacks:

“as being controlled by evil skeptics
Gorski ejaculates:

“No, seriously”
Bob bleats:


“You have to unleash the evil hoards of skeptics

“Wahahaha” 👿
Dr. Stanislaw Burzynski on Wikipedia:

“Simply don’t pay attention to it, because it, it’s not true”

“You won’t be able to, do any, clinical research which we do, without convincing evidence, especially when you have the most powerful agency in the government which is against you

“So they would love to find something which is wrong with what we are doing”

“Ah, so the fact that they’ve, um, agreed that what we have has value, and they allow us to do phase 3 clinical trials it means that we are right”

“Because, uh, uh, nobody who didn’t have any, concrete evidence that it works, would be able to go as far”

“So whatever Wikipedia says, well, I don’t care for them

(laughing) [5]
Enlightening ?

Inspiring ?

Amazing ?


Apparatchiks [20]
[1]David Gorski – Why We Fight (Part I): Stanislaw Burzynski Versus Science-Based Medicine – TAM 2013 11/8/2013 (22:44)

[2]Robert Blaskiewicz – Why We Fight (Part II): It’s All About The Patients – TAM 2013 11/8/2013 (22:36)

[3] – Medical Cranks And Quacks
11/8/2013 (42:42)

[4]“Galileo’s Lawyer” Richard A. Jaffe, Esq.
[5] – 11/9/2013 – Pete Cohen chats with Dr. Stanislaw Burzynski:
[6] – 6/2012 – Journal of Cancer Therapy, 2012, 3, 192-200 doi:10.4236/jct.2012.33028 Published Online June 2012, Pg. 192

Click to access 9219.pdf

[7]Burzynski: Oh, RATS!!!:
[8] – Critiquing: How Stanislaw Burzynski became Burzynski the Brave Maverick Doctor, part 1:
[9] – 9/19/2013 – Critiquing: National Cancer Institute (NCI) at the National Institutes of Health (NIH) CancerNet “fact sheet”:
[10] – 9/25/2013 – Critiquing: National Council Against Health Fraud, Inc. – NCAHF News: JURY NULLIFICATION THWARTS BURZYNSKI CONVICTION:
[11] – 7/9/2013 – Burzynski: The Original 72 Phase II Clinical Trials:
[12] – 4/26/2013 – Burzynski: FDA requirements that cancer patients utilize more traditional cancer treatment options in order to be eligible to participate in the Company’s Antineoplaston CLINICAL TRIALS:
[13] – Tori Moreno
[14] – 9/1999 – Pediatrics. 1999 Sep;104(3 Pt 1):435-9
[15] – 11/2/2013 – Critiquing: Dr. Stanislaw Burzynski’s cancer “success” stories:
10/25/2013 – Hannah Bradley – I Feel Empowered, In Control Of My Body: Four Women On Fighting Cancer With Alternative Therapies http://www.telegraph.co.uk/health/10383724/I-feel-empowered-in-control-of-my-body-four-women-on-fighting-cancer-with-alternative-therapies.html
[17] – 9/4/2013 – University of Michigan, where is alum Dr. David H. “Orac” Gorski’s Grapefruits ?:
[18] – 10/13/2013 – Why “The Skeptics™” Perfessor Robert J. (don’t call me “Bobby”) “Bob” Blaskiewicz (@rjblaskiewicz) of University of Wisconsin, Eau Claire, “Fame,” is a Coward and a Liar:
[19] – 10/27/2013 – “The Skeptics™” Burzynski Bias, Censorship, Lies, and Alibi’s: September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51
[20] – 11/9/2013 – Wikipedia Articles:

Critiquing David H. Gorski – Quackademic Medicine

Twenty-one (21) things I learned (first hand) from the recent screening of David H. Gorski – Quackademic Medicine
(Or, in layman’s terms: 21 pick-up)

David Gorski (@gorskon) tweeted at 8:12am – 30 Mar 13:

“Funny how you never see Orac and this person in the same place at the same time”

Orac (@oracknows) tweeted at 9:16am – 30 Mar 13:

Posted by Orac on March 30, 2013

“Three weeks ago, a certain


(one David H. Gorski, MD, PhD, FACS, managing editor of
@ScienceBasedMed @gorskon @oracknows)

of mine gave a talk to the National Capital Area Skeptics at the National Science Foundation in Arlington, VA”

The topic was one near and dear to my heart, namely quackademic medicine; so I couldn’t resist posting a link to the video”

(4/1/2013 – Amazingly the YouTube video displays “no stream” Quackademic Medicine – David H. Gorski, MD, NCASVideo: 1:19:14)

So in order to have a good laugh one must access:

1. Appropriately enough, GorskOrac starts with:

“What am I talking about here?”

Indeed !

2. It appeared that GorskOrac was not well prepared as he then refers to:

“a few months ago”


“last fall”

and finally settles on:


3. He stumbles over words repeatedly

4. He seemed unaware that the position of the microphone matters
(It was to the Right; from the view of the audience, his Left)

5. One wonders where the funding for this fiasco came from

6. The presentation wasn’t exactly “pabulum for the soul”

7. Attempts at trying to be witty were painful to hear

Luckily he had a golden parachute;
his audience, who sometimes failed to prevent the crash landing of a number of his “skepticisms”

8. He mentioned:

“I really wish I thought up

“Quackademic” Medicine”

But then again, this is the individual who couldn’t even think up

(Oxygen Radical Absorbance Capacity)

9. While describing an individual, he utters:

“He was a Quackademic before he turned to TV”

Leaving the listener to wonder if one is no longer a


once they have

“turned to TV”

10. GorskOrac eventually gets to

EBM = Evidence-based medicine

whereupon he ejaculates:

“But what does that really mean?”

I ask myself that quite a few times whenever I read Orac’s and his “Oracolytes'” blather on his blog, considering that a lot of it definitely does NOT contain much in the way of:

Evidence-based “facts”

11. He continues with:

“I like to point out there were other “BMs” before EBM”

To me, the video certainly brought to mind one of the biggest “BMs” known to Medicine:

“Bowel Movements”

12. He then goes on to mention

“3 of the most dangerous words in medicine”
(Experience-based medicine)

which is fitting, since Orac shows his “lack” of experience by stating, in relation to a person he was attempting to describe:

“It took her a few years but she died”

as if this particular “she” had been attempting to die for

“a few years”

13. Gorski refers to his Apple computer PowerPoint presentation display:

CAM according to NIH
(Complementary and Alternative Medicine according to the National Institutes of Health)

“Mind-body medicine”

and states:

“whatever that means”

It’s good to find out that just as with his blog, Davy knows his subject-matter in exquisite detail !

14. He refers to

“Manipulative … “

on the screen, and; not on list but he mentions


as if this; along with all the other “alternative” therapies he ridicules, is NOT an effective therapy; which sure explains how when I was doing “dipping” exercises and had something in my upper body get out of position so that when I breathed deeply it felt like a bone was poking one of my lungs, that I should have eschewed chiropractic therapy for drugs, in an attempt to mask the pain instead of dealing with the muscular-skeletal issue

15. Maybe this should be why David should stick to lecturing about

“Butt Hoaxes”

and the like

16. However, I do have to give him credit for making at least 2 “factual” statements:

“I’m not an expert at this”


“It’s not my area of expertise”

17. Gorskon then presents:

“When the pluralism of free speech is extinguished, speech as such is no longer meaningful”

This is obviously a concept that OracKnows does NOT seem to “know” all that well, considering he blocked my comments from being posted on his blog, where I was continually pointing out the



and / or


being posted on his blog and comments section

18. Dr. “Free Speech” then goes on to mention the “ubiquitous”


which aptly sums up his position on

“Free Speech”

19. Amusingly, a woman makes an appearance in the Q and A, positing; as opposed to “depositing BM”

“The only place … the best place to read … is the blog science based medicine . org

Gorski, I hope she was paid handsomely for her “ringing” endorsement

20. A man having experienced his “great” Memorial Sloan Kettering cancer experience:

“You’ve got Dr. Robert Lustig talking about sugar”

(which is timely, considering that on 3/28/2013, Dr. Lustig was on “The Colbert Report” talking to Stephen about sugar, and he has been an author on at least 24 cancer studies, including Phase I – III, and Randomized Clinical Trials)

21. David responds:

“Weeeell … ya know … the whole sugar feeds cancer thing”

Gorski, do you mean THIS:



“In cancer, for example, cells multiply at a much faster rate than normal cells, FEEDING ON SUGARS like glucose”

Society of Nuclear Medicine and Molecular Imaging

“In many types of cancer, diseased cells metabolize the sugar in FDG more avidly than normal cells, and so stand out clearly on a PET/CT scan

This is because cancerous cells grow at a faster rate than surrounding tissue, FEEDING ON SUGARS like glucose”

New England PET Imaging System

“All cells use glucose as an energy source

However, cancer cells grow faster than normal healthy cells and THEY USE GLUCOSE AT MUCH HIGHER RATE than normal cells”

Diagnostic Imaging Center at the NYU Clinical Cancer Center

“When disease strikes, the biochemistry of your tissues and cells changes

In cancer, for example, cells begin to grow at a much faster rate, FEEDING ON SUGARS like glucose”

University of Maryland Medical Center
University of Maryland Medical System in Partnership with the University of Maryland School of Medicine

“A PET/CT scanner is used to detect cancer

… a sugar solution, is given because

cancer cells FEED OFF OF THE SUGAR and create “hot spots” that the scan will pick up on”

University of Tennessee Medical Center

“cancer, for example, cells begin to grow at a much faster rate, FEEDING ON SUGARS like glucose”

North Mississippi Medical Center

“Use of PET/CT scanning in cancer patients:

technical and practical considerations”

“malignant cell UTILIZES MORE GLUCOSE to meet its energy needs”
Proc (Bayl Univ Med Cent). 2005 October; 18(4): 321–330
PMCID: PMC1255942
Baylor University Medical Center Proceedings

How many more would you like, Gorski???

(For some unknown reason, Orac could NOT handle a full hour of Q and A)

NO, this is NOT an “April Fools'” joke

Now, who has been “pwned”?

David Gorski (@gorskon) tweeted at 7:26am – 30 Mar 13:

My Critique of Orac’s: Stanislaw Burzynski versus regulations protecting human research subjects, revisited

Insolent Insolence

Here we go again

Unlike Orac

(David H. Gorski, @gorskon, @oracknows, @ScienceBasedMed, http://www.scienceblogs.com/Insolence, http://www.sciencebasedmedicine.org, #sciencebasedmedicine)

let’s compare Burzynski’s IRB to OTHER IRB’s

2/28/2013 – CoreValve

several cases in which site failed to obtain informed consent document (ICD)

2 cases – patients underwent CT angiography as screening procedure for trial without having signed screening ICD

3 cases – patients randomized into trial without having signed procedure ICD

investigator’s failure to notify within 5 days the sponsor or reviewing IRB of significant events

2 deaths
4/28/2011 – 1
5/11/2011 – 1
not reported to IRB until 10/21

2 cases – patients in trial underwent emergency procedures that deviated from trial protocol

1 case – no notification reported
1 case – deviation not reported for 5 weeks

“failure to maintain accurate, complete, and current records relating” to trial

2/12/2013 – FDA Warning Letters to Institutional Review Boards

11/29/2012 – Salem Hospital IRB

1. IRB failed to prepare and maintain adequate documentation of IRB activities

IRB is required to prepare and maintain adequate documentation of IRB activities including, but not limited to, copies of all research proposals, progress reports submitted by investigators, and all correspondence between IRB and investigators

IRB failed to adhere to requirement

Specifically, the IRB does not retain copies of the following:
a. Original protocols
b. Revised protocols
c. Informed consent documents
d. Protocol amendments
e. Progress report submissions, including all attachments
f. Correspondence between investigators and IRB

2. IRB failed to prepare and maintain adequate documentation of written procedures for IRB

IRB is required to prepare and maintain adequate documentation of written procedures for variety of IRB functions and operations

IRB failed to adhere to requirements

Specifically, IRB policies and procedures do not include written procedures to adequately address following functions and operations:

Conducting initial and continuing review or research;

Ensuring changes in approved research, during period for which IRB approval already given, may not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to human subjects; and

Ensuring prompt reporting to IRB, appropriate institutional officials, and FDA of any serious or continuing noncompliance with regulations or requirements or determinations of IRB, or any suspension or termination of IRB approval

3. IRB failed to prepare and maintain list of IRB members identified by name; earned degrees; representative capacity; indications of experience sufficient to describe each member’s chief anticipated contributions to IRB deliberations; any employment or other relationship between each member and institution

IRB is required to maintain list of IRB members

IRB failed to adhere to requirement

IRB didn’t update roster when membership changed between 12/3/2008 and 3/21/2011

a. IRB meeting minutes 1/21/2009, indicate (b)(6) is present as IRB member

IRB meeting minutes 7/22/2009 announce (b)(6)’s resignation from IRB

IRB roster 12/3/2008 – 3/21/2011 doesn’t list (b)(6) as member of IRB

b. IRB meeting minutes 10/21/2009 indicate (b)(6) approved to become IRB member

IRB meeting minutes 1/20/2010 list (b)(6) as IRB member and show her voting on IRB activities

IRB roster 12/3/2008 – 3/21/2011, doesn’t list (b)(6) as member of IRB

IRB membership rosters aren’t updated as changes in membership occur

Therefore, FDA may not be able to determine that IRB is duly constituted as required

4. IRB failed to review proposed research at convened meetings at which majority of members of IRB are present, including at least one member whose primary concerns are nonscientific areas

Except when expedited review procedure used, IRB may only review proposed research at convened meetings at which majority of IRB members present, including at least one member whose primary concerns are nonscientific areas

IRB failed to adhere to requirements

a. IRB minutes 3/18/2009 indicate 6 of 8 IRB members present

2 IRB members recused themselves during initial review and vote for Study

study approved with less than majority of members present

b. IRB minutes 4/21/2010 indicate 5 of 8 IRB members present

One IRB member recused himself during initial review and vote for Study

study approved with less than majority of members present

c. IRB minutes 10/20/2010 indicate 5 of 8 IRB members present

One IRB member recused himself during review and vote for protocol and informed consent document changes for Study

changes approved with less than majority of members present

maintenance of IRB rosters is important part of IRB activities in that it provides documentation of current membership

appropriate roster maintenance helps ensure proper # of members present at IRB meetings when approving research activities

5. IRB failed to follow FDA regulations regarding expedited review procedures

FDA regulations require under expedited review procedure, review may be carried out by IRB chairperson or one or more experienced reviewers designated by IRB chairperson from among members of IRB; and IRB may use expedited review procedure to review either or both of the following:

(1) Some or all of research appearing on Federal Register list of categories of research eligible for expedited review and found by reviewer(s) to involve no more than minimal risk; or

(2) minor changes in previously approved research during period for which approval authorized.

as stated in Federal Register notice, expedited review procedure may be used for continuing review as follows:

a. Where

(i) research is permanently closed to enrollment of new subjects;

(ii) all subjects have completed all research-related interventions; and

(iii) c research remains active only for long-term follow-up of subjects; or

b. Where no subjects enrolled and no additional risks identified; or

c. Where remaining research activities are limited to data analysis

IRB failed to comply when used expedited continuing review for research not eligible for approval through expedited review procedure

IRB meeting minutes 1/21/2009 indicate continuing review for Study was conducted by expedited review

memorandum from Clinical Investigator, 12/23/2008, requesting annual review for study indicates study was open to enrollment and 4 subjects were currently enrolled

continuing review of Study wasn’t eligible for expedited review

IRB’s written response 7/11/2012 acknowledges validity of each of the violations listed

response states that IRB will develop new written procedures to address each violation

However, draft procedures weren’t submitted with response and will not be available until 2/28/2013

IRB’s response inadequate because it doesn’t describe process that IRB will use to train and educate IRB members, staff, and clinical investigators with respect to new written procedures

Without information, FDA cannot conduct informed evaluation of proposed corrective and preventive action’s potential ability to prevent recurrence of these or similar violations in future

9/24/2012 – Texas Applied Biomedical Services IRB

determined that IRB significantly violated applicable federal regulations governing operation and responsibilities of IRBs (available at

This letter requests prompt corrective action to address the violations cited and discusses your IRB’s written response to noted violations

applicable provisions are cited for each violation

1. IRB failed to ensure no member participated in initial or continuing review of project in which member had conflicting interest

TABS RRC procedures manual, RRC Membership, states no member of Committee shall be involved in either initial or continuing review of activity in which he or she has conflicting interest, except to provide information requested by reviewing body

meeting minutes 1/26/2012 show 2 committee members, including you as Chairperson, participated in initial review and approval of clinical studies sponsored by (b)(4) (hereafter, (b)(4)) in which members had conflict of interest

Both you and (b)(6) voted to approve protocols sponsored by (b)(4) even though you both provided consulting services to (b)(4), assisting with writing protocols and informed consent documents, for which payment was requested

In your letter, you disagree with observation that TABS IRB members had conflict of interest with review of clinical studies

You explain that one of IRB committee members assisted in initial drafting of clinical study protocols and consulting services provided to (b)(4) by Texas Applied Biomedical Services and/or J Heinrich Consulting are not conflicts of interest

You further explain that consulting services provided “were maintained separate and apart from any TABS Research Review Committee functions and actions.”

We disagree with explanations

2 members in question had conflicting interest when they participated in initial review and approval of protocols and informed consent documents, which they assisted in drafting

Conflicting loyalties, whether conscious or not, may influence IRB’s deliberations

2. IRB failed to prepare, maintain and follow written procedures for conducting initial and continuing review of research

IRB doesn’t have written procedure regarding IRB’s method of reviewing protocols and consent forms to ensure safeguards in place for children who participate in clinical study

meeting minutes 1/8/2012 show IRB approved investigational (b)(4) study involving children (b)(4) years old

In your letter, you acknowledge that TABS RRC hadn’t previously reviewed clinical investigational research studies involving pediatric subjects

You also state that SOP (standard operating procedure) will be written addressing pediatric clinical studies

3. IRB failed to fulfill membership requirements

IRB didn’t possess professional competence necessary to provide complete and adequate review of specific research activities
For example:

A. 1/8/2012 IRB reviewed and approved investigational (b)(4) study involving pediatric and adult subjects with disorders of (b)(4)

Review of IRB’s records indicates IRB lacked professional competence necessary to review study and determine whether it met criteria for approval, including whether risks to subjects were “reasonable in relation to anticipated benefits, if any, to subjects, and importance of knowledge that may be expected to result.”

IRB didn’t include individual with professional competence in treatment of (b)(4) disorders (e.g., a physician), nor is there any documentation to show that IRB invited individuals with competence in this area to assist in review of this study

B. 1/26/2012 IRB reviewed and approved 2 studies involving subjects

IRB did not include individual with professional competence (e.g. a physician) in treatment of (b)(4), nor is there documentation to indicate IRB invited individuals with competence in this area to assist in review of study

In your letter, you disagree with this observation

You explain that TABS IRB doesn’t have medical doctor as active, regular voting member of committee, but committee has access to core group of medical advisors that provide expertise and input for any and all clinical research studies committee encounters

Your letter states independent consultant with extensive experience in (b)(4) research was consulted when IRB reviewed and approved 2 studies involving subjects

meeting minutes 1/26/2012 failed to include documentation of any consult with specialist that was taken into account by IRB committee in decision to approve studies

4. IRB failed to determine that pediatric study is in compliance

Under Additional Safeguards for Children in Clinical Investigations, IRBs are required to review clinical investigations involving children as subjects and approve only those clinical investigations that satisfy criteria within certain risk categories

A. meeting minutes 1/8/2012 show IRB reviewed and approved investigational study involving children

meeting minutes don’t document IRB’s determination of level of risk involved, potential for direct benefit, likelihood of yielding generalizable knowledge about subjects’ disorder or condition, and opportunity to understand, prevent, or alleviate serious problem affecting health or welfare of children

B. meeting minutes 1/8/2012 don’t document IRB discussed and/or determined adequate provisions made for soliciting assent of children involved in investigational study

In your letter you state that all future studies involving pediatric subjects will be more closely scrutinized

Also in your letter you reference FDA Guidance for IRBs and Clinical Investigators – Informed Consent Document Content which provides FDA doesn’t require informed consent document to contain space for assent by children

We don’t accept your explanation

observation on Form FDA 483 doesn’t speak to whether FDA requires Informed Consent document to contain space for assent by children

Instead, FDA investigator observed IRB failed to determine at time of initial review that research study was in compliance

requires IRBs to find and document clinical investigations involving children as subjects meets requirements

meeting minutes 1/8/2012 fail to document additional requirements for review of study involving pediatric subjects

5. IRB failed to prepare and maintain adequate documentation of IRB activities

A. IRB didn’t maintain meeting minutes for 2011

During inspection you told FDA investigator IRB met twice in 2011

According to study list, protocol was modified and approved 8/24/2011 but no meeting minutes were available for review documenting IRB’s activities

In your letter, you confirm there are no meeting minutes for 2011 during which 2 meetings were held

You explain that due to computer crash all minutes and data for time frame were lost

You stated you would “re-create” meeting minutes and provide at later date

It is inappropriate and unacceptable record keeping practice for IRB to re-create minutes for 2011

B. IRB failed to maintain meeting minutes with sufficient detail to show actions taken by IRB and vote on actions

meeting minutes 1/8/2012 fail to show which IRB members present at meeting voted for, against or abstained

IRB reviewed and approved investigational study during 1/8/2012 meeting however meeting minutes don’t document that IRB reviewed and agreed with sponsor’s determination of risk status of investigational to be used in study

In your letter, you stated there was oversight in transcription for 1/8/2012 meeting minutes in recording each member’s vote

Your letter also states you will ensure more complete minutes in future meetings by assigning clerical person to act as recording secretary for IRB meeting

IRB’s failure to maintain meeting minutes is repeat violation identified in last 2 FDA inspections conducted 2007 and 2000

C. IRB failed to maintain IRB membership rosters for 2008 – 2012

IRB membership rosters don’t identify members by representative capacity and employment or other relationship between each member and institution

This is repeat violation identified during FDA inspection in 2000

In your letter, you submitted a revised membership roster 5/11/2012

revised roster fails to comply with regulations because it doesn’t indicate you are affiliated member though you are president of TABS, Inc. and Chairperson of TABS RRC

In addition, (b)(6) is listed as non affiliated member, but immediate family members of employee of institution can’t be deemed nonaffiliated

Based on repeated deficiencies found during last 3 inspections, we have no assurance IRB procedures are adequately protecting rights and welfare of human subjects of research

For this reason, and effective immediately,

· FDA will withhold approval of all new studies and reviewed by IRB; and

· No new subjects are to be enrolled in any ongoing studies and approved by IRB

restrictions will remain in effect until such time as FDA has evidence of adequate corrective actions and notifies you in writing that IRB’s corrective actions are satisfactory.

restrictions don’t relieve IRB of responsibility for receiving and reacting to reports of unexpected and serious reactions and routine progress reports from ongoing studies

FDA Warns Stem Cell Company Over Violations

Last April, the FDA inspected

Celltex Therapeutics

9 pages:

Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product

You’ve manufactured (mesenchymal stem cells) MSC’s which you’ve released for distribution at least X times between 7/1/11 – present, however:

A. You haven’t performed a process validation for manufacturing MSC’s to assure batch uniformity and integrity as related to each of the following finished product characteristics: viability of cells, the specified cell count, cell type, and appearance of cells
B. You haven’t performed analyses on the final product to assure (b)(4) of the (b)(4) (b)(4) the final MSC’s
C. You haven’t verified the final product to assure the identity of the cell type in the final MSC’s
D. You haven’t performed assay to verify the MSC’s
E. you haven’t performed installation qualification, operational qualification, and performance qualification on the biological safety cabinets, the incubators, and the centrifuges
F. You haven’t performed a validation of your banking and thawing process to assure viability of MSC’s
G. You have no requirement for pressure differential between the clean rooms and the exterior rooms to assure that non-controlled air dose does not flow in the cleanrooms
H. You haven’t monitored the temperature or humidity of the processing rooms where you manufactured MSC’s

manufacturer’s manual for biological safety cabinets states they should be operated in environmental conditions of a (b)(4)

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile aren’t established, written, and followed

You’ve manufactured MSC’s which you released for distribution at least X times between 7/1/11 – present

MSC’s are intended to be administered to patients either intravenously or injected intra-articularly and must be sterile

The inspection revealed:

A. You’ve failed to validate aseptic MSC’s manufacturing process in order to prevent microbiological contamination

Sterility test failures have occurred of the following MSC’s: (b)(4), (b)(4), and (b)(4)
B. You’ve not validated your aseptic gowning process in order to prevent microbiological contamination

there’s no data to support validation/qualification of autoclave cycle

autoclave is used to sterilize gowning wardrobe (lab coat) and parts of incubators

C. You’ve not performed environmental swabbing of biological safety cabinets as part of environmental monitoring program

study hasn’t been performed to assure adequate air flow pattern underneath biological safety cabinet

biological safety cabinets used to aseptically manufacture MSC’s

D. Environmental test results of clean room, biosafety cabinets, and gowning area show isolation of microorganisms as result of use of settling plates

Some microbiological counts documented are beyond established specifications

There’s no data to show microorganism isolated have been identified or investigated

Written records are not made of investigations into the failure of a batch or any of its components to meet specifications


A failure investigation wasn’t performed for the following out of specification results and/or failures to determine the underlying reason or source of the failure

A. Sterility Testing: Sterility test results show the following MSC’s failed initial and repeat testing for sterility: (b)(4) and (b)(4)

The following MSC’s failed initial sterility before testing: (b)(4) and (b)(4)

B. Endotoxin Testing: Endotoxin test results show the following MSC’s units failed initial endotoxin testing on 12-20-11, on 12/7/11, and on 11-10-11

C. Environmental Testing: Bacteria and Fungi tests have been exceeded for the BSC-(Biosafety Cabinet-CleanRoom Gowning Area, (CleanRoom) (CleanRoom and BSC) (Biosafety Cabinet-Clean Room) BSC-M (Biosafety Cabinet-Manufacturing), BSC-Q (Biosafety Cabinet-Quality Control), CleanRoom

In addition there is no written procedure for conducting failure investigations

Drug product production and control records, are not reviewed by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed


You manufactured MSC’s you released for distribution at least X times between 7/1/11- present

you haven’t reviewed all manufacturing records, test records, endotoxin test records, or sterility test records prior to the release for distribution of the MSC’s that you manufactured as evidenced by the following:

A. inspector signature line on manufacturing record 10-20-11 blank

According to outgoing log MSC’s released for intravenous infusion 10-21-11

B. inspector signature line on manufacturing record 7-26-11 blank

According to outgoing log MSC’s released for intravenous (IV) infusion 10-11-11

C. inspector signature line on manufacturing record 10-6-11 blank

According to outgoing log MSC’s released for intravenous (IV) infusion 10-7-11

Batch production and control records don’t include complete information relating to production and control of each batch


A. You don’t document the addition of (b)(4) to your (b)(4) and (b)(4) media used in the manufacture of MSC’s

B. You don’t document the addition of (b)(4) to the (b)(4) media used for banking of MSC’s

C. You don’t document the checks of culture-expansion flasks of MSC’s for evidence of contamination

D. Manufacturing records lack required signatures