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Tag Archives: "eligibility criteria"
[24] – 1995 (10/27/1995) – Burzynski to Dr. Richard Klausner (7 pgs.)
[24] – 1995 (10/27/1995) – Burzynski 7 page letter to Richard Klausner, M.D., Director, National Cancer Institute (NCI), National Institutes of Health (NIH)
I was shocked to read the Cancernet "fact sheet" the NCI has been distributing about the cancellation of the clinical trials of antineoplastons, the anti-cancer drugs I discovered and developed
I find it scandalous that a government agency is putting out a public document containing such blatantly false information
Let me remind you that the only reason the clinical trials of antineoplastons were stopped is that NCI would not conduct them as per our written agreement
NCI's "fact sheet" tries to obscure that simple fact with misinformation such as the following:
"In 1991, a "best case series" review was conducted by the National Cancer Institute (NCI) to evaluate clinical response in a group of patients treated at Dr. Burzynski's Houston facility
For this review, Dr. Burzynski selected from his entire clinical experience 7 brain tumor patients whom he felt had a beneficial effect from antineoplastons."
This misstatement is obviously calculated to make the reader think that in my entire clinical experience I have had only 7 patients who benefitted from antineoplaston treatment, which is wildly untrue
In fact, I prepared not 7, but dozens of cases for the NCI reviewers
As you must know, the reviewers were able to spend just one day at the clinic–enough time to review only 7 cases
Cancernet then compounds that misstatement with the following:
"This series did not constitute a formal clinical trial, since it was a retrospective review of medical records, did not include all available information, and included only cases selected by Dr. Burzynski" (my italics)
To the contrary, the patient medical records that NCI scientists reviewed were exhaustive and did contain "all available patient information."
In fact, Michael Hawkins, M.D., leader of the site visit team, specifically complimented me on how complete and well-organized they were
The next misstatement is the following:
"The reviewers of this series determined that there was presumptive evidence of antitumor activity . . ."
Now that the NCI's Cancer Therapy Evaluation Program (CTEP) is under fire for misconduct in these clinical trials, it is rewriting history
The statement of the NCI scientists who actually reviewed patient records was quite different from the above
Their report (minutes of Decision Network committee meeting enclosed) stated that "The site visit team determined that antitumor activity was documented in the best case series and that the conduct of Phase II trials was indicated to determine the response rate" (my italics)
In other words, according to the site visit team, there was no question that the treatment worked in the cases reviewed
All that remained to be determined were the numerator and the denominator
Even the NCI's own previous "fact sheet" on antineoplastons, dated 2/17/1994, (enclosed), states that
"The NCI reviewed 7 cases of patients with primary brain tumors that were treated by Dr. Burzynski with antineoplastons and concluded that antitumor responses occurred" (my italics)
But by far the most outrageous misstatement is the following:
"On 8/18/1995, the studies were closed because a consensus could not be reached with Dr. Burzynski on the proposed changes to the protocol to increase accrual, and there was no hope of completing the studies in a timely manner."
The NCI never made any effort to "reach a consensus."
Instead, it simply violated the written protocol we had agreed upon
Without informing me, NCI changed the rules to allow patients with any size or number of tumors, low performance scores, and spinal cord metastases
in other words, NCI was accepting patients whose brains and spinal cords were literally consumed by large malignant tumors–patients so advanced as to have no chance whatsoever
When I found out and insisted that NCI either conduct the study as agreed or inform patients that I felt it was conducting the study improperly, NCI cancelled it
The above is all well documented
While we were still in the negotiating stages, Michael Friedman, M.D. of the NCI wrote me a letter dated 11/2/1993 (enclosed) ". . . we will accede to all the modifications that you have stipulated."
Dr. Friedman specifically agreed to exclude patients with:
* tumors larger than 5 cm (2 inches)
* multiple tumors
* metastases to spinal cord
* Karnofsky performance scores less than 70%
Based on Dr. Friedman's written assurance that NCI would honor this exclusion criteria, I provided NCI with a large quantity of antineoplastons, and the clinical trial began
on 3/23/1994, Mario Sznol, M.D., of NCI wrote me proposing that NCI drop the exclusion for multiple tumors and spinal cord metastases, increase the maximum tumor size from 5 cm to 8 cm, and lower the Karnofsky score from 70 to 60 (enclosed)
in a response dated 4/19/1994 (enclosed), I wrote back that I would be glad to help NCI design a separate trial for such advanced patients, using a more aggressive dosage schedule
But I made it clear that it would be unethical to use the current dosage schedule on such patients since my experience had shown that such patients do not respond well to it
As proof , I pointed out that in the NCI's own review of patients treated with antineoplastons, the only ones who had less than 50% tumor shrinkage were exactly those with tumors greater than 5 cm
I did not hear back from NCI and assumed the matter had been dropped
Nearly one year later–in 3/1995–I learned that NCI had made all the changes to which I had objected
In fact, NCI went even further
Rather than raising the maximum tumor size from 5 to 8 cm as the NCI earlier suggested, it began accepting patients with any size tumor
I insisted that NCI either honor our agreement or change the Informed Consent statement (which patients must read and sign) to reflect the fact that I, the drug's discoverer and developer, felt that the treatment was unlikely to be effective in such advanced patients in the doses being used
Rather than honor it's commitment to conduct the study as agreed, NCI cancelled it
I find it particularly curious that now neither NCI nor Memorial Sloan-Kettering Cancer Center (MSK) will take responsibility for changing the exclusion criteria, and are instead pointing fingers at each other
in his letter of 4/3/1995 (enclosed), Dr. Sznol repeatedly refers to the "revised" eligibility criteria proposed by the [Memorial Sloan-Kettering] investigators" (my italics)
But, in a letter to John Lewis, M.D., of Memorial Sloan-Kettering's Institutional Review Board dated 1/31/1995 (enclosed), the Chief Investigator, MSK's Mark Malkin, M.D., writes that
"Further amendments, as described below, have been made at the request of NCI" (my italics)
If the changes to the protocol are as the NCI would have the world believe, why is everyone connected to them scurrying to disavow responsibility?
An even more serious matter is what appears to be the investigator's relentless violations of the treatment protocol
Looking at the treatment summaries compiled by Theradex Corporation, the medical reporting company hired by NCI to compile and tabulate patient treatment data, it would appear that investigators violated the agreed-upon protocol in every patient treated
Apparent violations include the removal of patients from treatment who had no tumor growth (including one patient who, during subsequent surgery, was found to have no cancer cells remaining), and the removal of a patient for "skin reactions" caused not by antineoplastons, but by another drug patient was receiving, DPH
This is clear due to the fact that the patient's skin condition worsened when he was taken off antineoplastons
It improved only after DPH was discontinued
The summaries provided by Theradex are somewhat sketchy, so I asked to review the complete records of patients tested–which Dr. Friedman had specifically promised to provide
NIH lawyer Robert Lanman replied in a letter dated 8/23/1995 (enclosed) that the NCI did not have any such records
In fact, several patients were treated at NCI and of course NCI has their complete medical records
When I demonstrated this by sending Mr. Lanman copies of patient records obtained by a patient's family from NCI, he admitted in fact NCI does have patient records, but refused to release them
And he disregarded his own misstatements of fact by saying that
"Given that you apparently have already obtained at least one of the patient's records, we fail to understand why you are perusing this matter" (letter from Robert Lanman dated 10/5/1995 enclosed)
Mr. Lanman also claims that NCI has "no such commitment" to release medical records of patients treated with antineoplastons
And Dr. Friedman, in a letter dated 9/19/1995 (enclosed), writes that Dr. Burzynski's request for "detailed records" has been satisfied by the sketchy Theradex treatment summaries
Both these statements directly contradict Dr. Friedman's letter of 11/2/1993 (enclosed), in which he promises that
"In accordance with your letter, we will arrange a review of data after accrual of the 1st 5-6 patients, which should occur 6 months after the study has been initiated
This should be sufficient to assure that the conduct of the study is satisfactory
The Theradex database is also available . . ." (my italics)
In other words, Dr. Friedman promised to provide me with patient medical records, recognizing that the Theradex summaries are something quite separate
In that same 9/19/1995 letter, Dr. Friedman writes that
"We have no individual patient records in our possession in addition to the Theradex reports."
Either he is deliberately misstating the facts, or he is out of touch with the Cancer Therapy Evaluation Program that he runs
Dr. Klausner, I request that you immediately withdraw the "fact sheet" the NCI is distributing which contains numerous and outrageous misstatements and distortion of fact
Thank you for your attention to this matter
SRB/cf
3+ pgs cc:
1993 (11/2/1993) – Dr. Michael Friedman to Burzynski
1994 (2/17/1994) – NCI "fact sheet"
1994 (3/23/1994) – Dr. Mario Sznol to Burzynski
1994 (4/19/1994) – Burzynski to Dr. Mario Sznol
1995 (1/31/1995) – Dr. John L. Lewis
1995 (4/3/1995) – Dr. Mario Sznol to Burzynski
1995 (8/18/1995) –
1995 (8/23/1995) – Robert B. Lanman to Burzynski
1995 (9/19/1995) – Dr. Michael A. Friedman to Burzynski
1995 (10/5/1995) – Robert B. Lanman to Burzynski
Posted in Cancer Therapy Evaluation Program (CTEP), critique, critiques, critiqued, critiquing, Decision Network, Department of Cancer Treatment (DCT), Department of Health & Human Services (HHS), John L. Lewis, M.D., Mario Sznol, M.D., Mark G. Malkin, M.D., Memorial Sloan-Kettering Cancer Center (MSKCC), Michael A. Friedman, M.D., National Cancer Institute (NCI), National Institutes of Health (NIH), Richard A. Jaffe, Robert B. Lanman, NIH Legal Advisor, Stanislaw Rajmund Burzynski | Tagged "aggressive dosage schedule", "anti-cancer drugs", "antitumor responses occurred", "best case series", "cancer cells", "Cancer Therapy Evaluation Program (CTEP)", "Cancer Therapy Evaluation Program", "Cancernet "fact sheet", "Chief Investigator Mark Malkin, "Critiquing: Dr. Michael A. Friedman Dr. Mark G. Malkin Dr. Mario Sznol Robert B. Lanman Memorial Sloan-Kettering Cancer Center Mayo Clinic Department of Health & Human Services (HHS) Public Healt, "Decision Network committee meeting", "disavow responsibility", "distortion of fact", "dosage schedule", "Dr. Burzynski", "Dr. Friedman", "Dr. John L. Lewis", "Dr. Klausner", "Dr. Mario Sznol", "Dr. Michael A. Friedman", "Dr. Richard Klausner", "Dr. Sznol", "eligibility criteria", "false information", "government agency", "increase the maximum tumor size from 5 cm to 8 cm", "Informed Consent statement", "John Lewis M.D. Memorial Sloan-Kettering's Institutional Review Board", "Karnofsky performance scores less than 70%", "Karnofsky score from 70 to 60", "large malignant tumors", "less than 50% tumor shrinkage", "Mario Sznol M.D.", "Memorial Sloan-Kettering investigators", "metastases to spinal cord", "Michael Hawkins M.D. leader of the site visit team specifically complimented me on how complete and well-organized they were", "misstatements of fact", "multiple tumors", "NCI fact sheet, "NCI scientists", "NIH lawyer Robert Lanman", "patient medical records", "patient treatment data", "phase II trials", "public document", "response rate", "Richard Klausner M.D. Director National Cancer Institute National Institutes of Health, "Robert B. Lanman", "site visit team", "spinal cord metastases", "Theradex Corporation, "tumor growth", "tumors greater than 5 cm", "tumors larger than 5 cm (2 inches)", antineoplastons, "all available patient information.", "detailed records", "Further amendments", "individual patient records", "no such commitment", "patients with primary brain tumors", "reach a consensus.", "Robert Lanman", "skin reactions", "The reviewers of this series determined that there was presumptive evidence of antitumor activity", "we will accede to all the modifications that you have stipulated.", Cancernet, Clinical Trial, DPH, exclusion, https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/, M.D.", misconduct, misstatements, National Cancer Institute (NCI), protocol, SRB/cf, the medical reporting company", Theradex | Leave a reply
[19] – 1995 (6/6/1995) Dr. Michael A. Friedman to Burzynski (3 pgs.)
[19] – 1995 (6/6/1995) – Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health and Human Services (HHS), Public Health Service, National Institutes of Health (NIH) 3 page letter to Burzynski
This letter is intended to respond to the major issues which have been raised in your recent correspondence of 4/20/1995 and 5/16/1995
Your accusations are serious and require comment
I will 1st address the questions you raised about individual patients participating in the NCI-sponsored antineoplaston studies
2 patients were treated at the National Cancer Institute
Patient .26-77-03-9 had evidence of focal glioblastoma multiforme on the biopsy reviewed at the NCI
A different specimen submitted to Dr. Rorke may or may not be relevant
This patient, however, had a brain scan 3 weeks prior to study entry
Patient .27-53-76-5 had a tumor which was 0.8 cm larger than the eligibility criteria dictated
Although pharmacologic data were obtained on both, neither patient is counted in an assessment of response
Both patients had objective tumor progression and are now off study
With respect to the other patients, I am including specific patient summaries from the treating investigators which address your other concerns; in particular, a response to your serious and unfounded statement that patient #196370 was treated in an unethical manner
Also contrary to your statement, you have been sent monthly clinical summaries of these patients since 7/1994 directly from Theradex
(see 3/9/1994 letter)
Having provided this information, I must convey my deep pessimism about the potential for continued interactions with you regarding these trials
Given recent events and your clearly articulated bias that the Mayo Clinic, Memorial Sloan Kettering Hospital and even the National Cancer Institute could not fairly test your product
(please see your letters of 10/26/1993 and 4/20/1995),
I now see a diminishing chance for a productive dialogue with you
Historically, the NCI has demonstrated pragmatism and flexibility in working with a wide variety of individuals and organizations to explore diverse interventions of potential benefit to the cancer patient
However, such a fruitful collaboration may simply not be possible with you
The decision to suspend the NCI antineoplaston studies was reached by the investigators and the NCI and was explained in our letter of 5/12/1995
(see enclosed)
While we have frequently solicited your advice, we are in no way obligated to obtain your consent
Our interactions with you have been similar to those with pharmaceutical companies or other independent investigators
In the interest of testing antineoplastons, we have consistently considered your advice and recommendations but that in no way cedes control of these studies to you
(please refer to our letters of 7/15/1993, 10/20/1993, and 11/2/1993)
Your insistence on dictating the manner in which we conduct our review of these clinical trials is both presumptuous and inappropriate
The future of these trials rests entirely with the investigators and the NCI, since our primary obligation is to the American public
Recognizing your potential conflict of interest as the developer and the most visible proponent of antineoplastons, we could not responsibly act in any other manner
In contrast to the tenor of your unsupported statements, the NCI bases its position on scientific data
You have stated that you have a vast clinical experience with antineoplastons and we have generally been deferential to your demands despite the lack of substantive data
However, our scientific standards are broadly applied to all studies
The data and level of proof we require from you is much the same as that for other professional collaborators who make such claims
The 7 case records initially examined by the NCI hardly constitute a definition scientific result
It is naive and misleading for you to suggest that the experience of 2 of those patients who had tumors in excess of 5 cm provides adequate proof for all your contentions about tumor size, dose, etc., unless these were the only 7 brain tumor patients from your entire experience who had any hint of benefit
To be precise, in order to responsibly and properly assess your claims and accusations (as per your 4/20/1995 letter), we request that you provide the following information:
1. Exactly how many adult patients with primary brain tumors have you evaluated and treated with antineoplastons?
2. When analyzed by histological type, performance status, prior therapy, concurrent therapy (including chemotherapy), disease size and focality, how many adult brain tumor patients had objective responses?
Please characterize the quality and magnitude and duration of these responses
3. What dose, duration, schedule, and composition of antineoplastons did these patients receive?
Which of these patients benefited objectively?
What toxicities were encountered?
Do you have pharmacokinetic or pharmacodynamic data to support your contention that certain types of brain tumor patients require specific regimens?
4. For these patients, what statistical analyses relate patient or tumor characteristics with exact treatment regimen and outcome?
If you provide such specific data, we can properly assess your claims
Lacking such information, we cannot
Moreover, your charges that patients received inappropriate care are not supportable without such detailed information
If, after careful consideration, the investigators at Memorial Sloan Kettering and Mayo Clinic do not reopen their studies, it is unlikely that the NCI will attempt to conduct further antineoplaston trials
Any unused antineoplaston material will, of course, be returned to you
Since we can make no judgement about the benefit or toxicity of antineoplastons at this time, we will be interested in the published outcome of peer reviewed studies that you or others may perform
If the NCI investigators choose to continue these studies, you will be so informed
In either circumstance, we will continue to sponsor clinical research of small molecules that may have differentiating properties (such as pure phenylacetate and phenylbutyrate)
Senator Joseph Biden
Senator Barbara Boxer
Senator Diane Feinstein
Senator Tom Harkin
Senator Barbara Mikulski
Congressman Berkley Bedell
Congresswoman Nancy Pelosi
Dr. Jan Buckner
Dr. Jay Greenblatt
Mr. Richard Jaffe
Mr. Robert Lanman
Ms. Mary McCabe
Dr. Mark Malkin
Dr. Tony Murgo
Dr. Ralph Moss
Dr. David Parkinson
Dr. Edward Sondik
Dr. Mario Sznol
Dr. Dorothy Tisevich
Dr. Alan Trachtenberg
Mr. Frank Wiewel
Dr. Robert Wittes
1993 (10/26/1993) – Burzynski to
1994 (3/9/1994) –
1994 (7/1994) – Burzynski to Theradex
1995 (4/20/1995) – Burzynski to
1995 (5/12/1995) – to Burzynski
Posted in critique, critiques, critiqued, critiquing, Department of Health & Human Services (HHS), Michael A. Friedman, M.D., National Cancer Institute (NCI), National Institutes of Health (NIH), Stanislaw Rajmund Burzynski | Tagged " Memorial Sloan Kettering Hospital", "adult brain tumor patients", "adult patients with primary brain tumors", "American public", "brain scan", "brain tumor patients", "cancer patient", "concurrent therapy", "Congressman Berkley Bedell", "Congresswoman Nancy Pelosi", "differentiating properties", "disease size", "Dr. Alan Trachtenberg", "Dr. David Parkinson", "Dr. Dorothy Tisevich ", "Dr. Edward Sondik", "Dr. Jan Buckner", "Dr. Jay Greenblatt", "Dr. Mario Sznol", "Dr. Mark Malkin", "Dr. Michael A. Friedman Dr. Mark G. Malkin Dr. Mario Sznol Robert B. Lanman Memorial Sloan-Kettering Cancer Center Mayo Clinic Department of Health & Human Services (HHS) Public Health Service Qu, "Dr. Ralph Moss", "Dr. Robert Wittes", "Dr. Rorke", "Dr. Tony Murgo", "Dr. Wayne Jonas", "eligibility criteria", "focal glioblastoma multiforme", "histological type", "independent investigators", "Mayo Clinic", "Memorial Sloan Kettering", "Michael A. Friedman M.D. Associate Director Cancer Therapy Evaluation Program (CTEP) Division of Cancer Treatment (DCT) National Cancer Institute (NCI) Department of Health and Human Services (HHS) P, "monthly clinical summaries", "Mr. Frank Wiewel", "Mr. Richard Jaffe", "Mr. Robert Lanman", "Ms. Mary McCabe", "NCI investigators", "NCI-sponsored antineoplaston studies", "objective responses", "objective tumor progression", "patient #196370", "peer reviewed studies", "performance status", "pharmaceutical companies", "pharmacologic data", "potential conflict of interest", "prior therapy", "professional collaborators", "scientific data", "scientific standards", "Senator Barbara Boxer", "Senator Barbara Mikulski", "Senator Diane Feinstein", "Senator Joseph Biden", "Senator Tom Harkin", "small molecules", "specific patient summaries", "sponsor clinical research", "tumor size", "tumor which was 0.8 cm larger", "tumors in excess of 5 cm", "unethical manner", antineoplaston, antineoplastons, "Patient 26-77-03-9", "Patient 27-53-76-5", biopsy, CHEMOTHERAPY, Clinical Trials, focality, https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/, National Cancer Institute, pharmacodynamic, pharmacokinetic, PHENYLACETATE, PHENYLBUTYRATE, Theradex, toxicities, toxicity | Leave a reply
[14] – 1995 (3/29/1995) – Burzynski to Dr. Michael A. Friedman (2 pgs.)
Michael A. Friedman, M.D., Associate Director,Cancer Therapy Evaluation Program, Division of Cancer Treatment, NCI, National Institutes of Health
Dear Dr. Friedman,
It has been brought to my attention that the protocol
"Phase II Study of Antineoplastons A10 and AS2-1 in Patients with Advanced Recurrent Malignant Astrocytomas"
has been amended to accept patients with tumors measuring over 5 cm in diameter, multiple tumors, or with leptomeningeal or systemic metastases
Another change involves lowering of the Karnofsky Performance Status score to 60%
You assured me in your letter of 11/2/1993 that
"The dose and schedule will be modified exactly as you require"
"The eligibility criteria will be modified to accept only patients with Karnofsky Performance Status of 70% – 100%
I am outraged that without my knowledge Memorial Sloan-Kettering Cancer Center with NCI's permission changed the protocol
Treatment of patients with tumors larger than 5 cm, with multiple tumors, and leptomeningeal spread or distant metastases will require a different protocol with a different schedule and different dosages
the use of the existing protocol for such very advanced brain tumor patients will only expose them to unnecessary risks without giving them substantial benefit
I hereby request that the amendments described above be cancelled immediately and the original protocol be used for the treatment as promised in your letter of 11/2/1993
We will be glad to propose a different protocol for patients with larger and multiple tumors and meningeal involvement
In addition, the procedure we agreed upon calls for a thorough review by us of the 1st 5 patients as soon as they are accrued
Your last annual report indicates
that you had accrued that number of patients 6 months ago
As a result, the review of data is long overdue
Please send us the complete records of the 1st 5 patients so that we may review them as specified
Please do not accrue any more patients until this data has been sent and our review completed
Dr. Jan Bruckner
Dr. Michael C. Christian
Ms. Dorothy Tisevich
1993 (11/2/1993) – Dr. Michael A. Friedman to Burzynski
Posted in critique, critiques, critiqued, critiquing, Mario Sznol, M.D., Mark G. Malkin, M.D., Michael A. Friedman, M.D., National Cancer Institute (NCI) | Tagged "Critiquing: Dr. Michael A. Friedman Dr. Mark G. Malkin Dr. Mario Sznol Robert B. Lanman Memorial Sloan-Kettering Cancer Center Mayo Clinic Department of Health & Human Services (HHS) Public Healt, "Dr. David Parkinson", "Dr. Friedman", "Dr. Jan Bruckner", "Dr. Jay Greenblatt", "Dr. Mario Sznol", "Dr. Mark Malkin", "Dr. Michael A. Friedman", "Dr. Michael C. Christian", "eligibility criteria", "Karnofsky performance status of 70-100%", "lowering of the Karnofsky Performance Status score to 60%", "Memorial Sloan-Kettering Cancer Center", "Michael A. Friedman M.D. Associate Director Cancer Therapy Evaluation Program Division of Cancer Treatment NCI National Institutes of Health", "Ms. Dorothy Tisevich", "Ms. Mary McCabe", "patients with larger and multiple tumors and meningeal involvement", "patients with tumors larger than 5 cm with multiple tumors and leptomeningeal spread or distant metastases", "patients with tumors measuring over 5 cm in diameter multiple tumors or with leptomeningeal or systemic metastases", "Phase II Study of Antineoplastons A10 and AS2-1 in Patients with Advanced Recurrent Malignant Astrocytomas", "The dose and schedule will be modified exactly as you require", https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/, NCI, protocol, SRB/cf | Leave a reply
[9] – 1993 (11/2/1993) – Dr. Michael A. Friedman to Burzynski
[9] – 1993 (11/2/1993) – Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment, National Cancer Institute (NCI), Department of Health & Human Services (HHS), Public Health Services, National Institutes of Health (NIH) to Burzynski [3 pgs.]
Department of Health and Human Services, Public Health Services, National Institutes of Health
Dear Dr. Burzynski:
With regard to your letter of 10/26/1993, you specifically state
"The medicine will be sent to you immediately once you make the corrections to the protocol that we have requested"
We have substantial factual disagreements and scientific reservations with many of the comments made in your 10/26/1993 letter, including your preposterous claim that the NCI wasted 8 months
Nonetheless, we will accede to all the modifications that you have stipulated
We do so because we are committed to beginning the clinical studies as quickly as possible
We presume that these are your final comments, since all the changes will have been made and we will have addressed all of your concerns regarding these studies
The revised protocol will be sent to you as soon as it is received from the investigators
Based on the promise in your letter, we expect that the drug will be shipped to the NCI repository the next day
The changes to made to the protocol are as follows:
1. The dose and schedule will be modified as exactly as your require
We believe this to be the dose and schedule found in your protocol BT6, with dose escalation and maximum dose guidelines for adults clarified in your letter of 10/13/1993
2. The Memorial study, as written, has 2 separate components, one for patients with glioblastoma multiforme and one for patients with anaplastic astrocytoma
Accrual to each stratum proceeds independently, and analyses of each stratum is separate
However, we will ask the investigators from Mayo Clinic to join the Memorial study, rather than conducting an independent trial
This will effectively evaluate on the one hand patients with glioblastoma multiforme, and on the other hands those with anaplastic astrocytoma
Patients with either disease will be enrolled at both Memorial and Mayo sites
This modification has 2 advantages — it limits total accrual to 35 patients per histology, as you request; and it accelerates accrual, since each institution can enter both types of patients on the studies
3. As you stipulated, Fleming's original statistical design will be used utilized
15 patients will be entered independently to each stratum; for each stratum, if there is 1 response, accrual will proceed to a total of 35 patients
Thus total accrual will be 70 patients if both strata proceed past the 1st stage
(the initial 15 patients per histology)
4. According to your wishes, all scans for tumor measurements and laboratory test will be performed within 7 days of initiating protocol therapy, rather than the standard 14 days now specified in the protocol
5. The eligibility criteria will be modified to accept only patients with a Karnofsky performance status of 70-100%
6. As you require, the protocol response criteria will be based on objective tumor measurements and will not include assessment of neurologic status
Neurologic status will be evaluated separately
7. In accordance with your letter, we will arrange a review of data after accrual of the 1st 5-6 patients, which should occur 6 months after the study has been initiated
The Theradex database is also available to precisely determine if the conduct of the study has followed protocol guidelines; the study centers will also be audited on-site by Theradex (independent contractors) every 3 months
In your letter you express concern regarding what you perceive to be bias against alternative treatments by Mayo Clinic and Memorial investigators
Please note that the investigators participating in the antineoplaston studies volunteered to do so because of the findings of the NCI review of your best case series
To my knowledge none of the participating investigators have expressed (publicly or privately) a position for or against Antineoplastons
Both institutions have a distinguished record in clinical investigations, and have been leaders in subjecting all treatments (including alternative interventions) to fair and objective clinical research
We are confident that credible clinical studies will be conducted
Finally, if even after modifying these studies in accordance with your stated wishes, you are unwilling to supply the antineoplaston materials, please inform me as quickly as possible
We will then seek alternative sources of this family of molecules for proper clinical evaluation
Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program, Division of Cancer Treatment, NCI
Dr. Samuel Broder
Dr. Bruce Chabner
Dr. Joseph Jacobs
1993 (11/2/1993) – Dr. Michael A. Friedman to SRB [9]
1993 (11/2/1993) – Dr. Michael A. Friedman to Burzynski [14]
1993 (11/2/1993) – Dr. Michael A. Friedman to SRB [19] (3 pgs.)
1993 (10/13/1993) – Burzynski to Dr. Michael A. Friedman
Posted in Bruce A. Chabner, M.D., critique, critiques, critiqued, critiquing, Mario Sznol, M.D., Mark G. Malkin, M.D., Michael A. Friedman, M.D., National Cancer Institute (NCI) | Tagged "alternative treatments", "ANAPLASTIC ASTROCYTOMA", "clinical evaluation", "credible clinical studies", "Critiquing: Dr. Michael A. Friedman Dr. Mark G. Malkin Dr. Mario Sznol Robert B. Lanman Memorial Sloan-Kettering Cancer Center Mayo Clinic Department of Health & Human Services (HHS) Public Healt, "dose escalation", "Dr. Bruce Chabner", "Dr. Burzynski", "Dr. David Parkins", "Dr. Jan Bruckner", "Dr. Jay Greenblatt", "Dr. Joseph Jacobs", "Dr. Mario Sznol", "Dr. Mark Malkin", "Dr. Samuel Broder", "eligibility criteria", "factual disagreements", "family of molecules", "Fleming's original statistical design", "glioblastoma multiforme", "Karnofsky performance status of 70-100%", "laboratory test", "maximum dose guidelines", "Mayo Clinic", "Memorial investigators", "Michael A. Friedman M.D. Associate Director Cancer Therapy Evaluation Program (CTEP) Division of Cancer Treatment National Cancer Institute (NCI)bDepartment of Health & Human Services (HHS) Publi, "Michael A. Friedman M.D. Associate Director Cancer Therapy Evaluation Program Division of Cancer Treatment NCI", "Ms. Dorothy Tisevich", "Ms. Mary McCabe", "neurologic status", "objective tumor measurements", "protocol BT6", "protocol response criteria", "Public Health Services", "scientific reservations", "Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies", "Theradex database", "tumor measurements", adults, antineoplaston, antineoplastons, bias, Department of Health and Human Services, Histology, https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/, medicine, National Institutes of Health, protocol, strata, stratum, Theradex | Leave a reply


text:
Q: Convert some code from C# to VB.net throws error at compile time I am trying to convert following code to VB.net
private void Application_Start(object sender, EventArgs e)
    {
        var defaultTableData = new DefaultTableData();
        defaultTableData.CheckAndUpdate();

        if (ConfigurationManager.AppSettings["RSAConfigSwitch"].ToString().ToUpper() == "ON")
        {
            FederatedAuthentication.ServiceConfigurationCreated += new EventHandler<ServiceConfigurationCreatedEventArgs>(FederatedAuthentication_ServiceConfigurationCreated);

        }

    }

    void FederatedAuthentication_ServiceConfigurationCreated(object sender, Microsoft.IdentityModel.Web.Configuration.ServiceConfigurationCreatedEventArgs e)
    {
        String certName = ConfigurationManager.AppSettings["CertificateName"].ToString(); // read from web.config
        System.Security.Cryptography.X509Certificates.X509Store store = new System.Security.Cryptography.X509Certificates.X509Store(System.Security.Cryptography.X509Certificates.StoreName.My, System.Security.Cryptography.X509Certificates.StoreLocation.LocalMachine);
        store.Open(OpenFlags.ReadOnly);
        System.Security.Cryptography.X509Certificates.X509Certificate2Collection col = store.Certificates.Find(System.Security.Cryptography.X509Certificates.X509FindType.FindBySubjectName, certName, true);
        var cookieProtectionCertificate = col[0];

        e.ServiceConfiguration.SecurityTokenHandlers.AddOrReplace(
            new SessionSecurityTokenHandler(new System.Collections.ObjectModel.ReadOnlyCollection<CookieTransform>(
                new List<CookieTransform>
                    {
                        new DeflateCookieTransform(),
                        new RsaEncryptionCookieTransform(cookieProtectionCertificate),
                        new RsaSignatureCookieTransform(cookieProtectionCertificate)
                    })
            ));
    }

Converted VB code
Sub Application_Start(ByVal sender As Object, ByVal e As EventArgs)
        ' Fires when the application is started
        FederatedAuthentication.ServiceConfigurationCreated += New EventHandler(Of ServiceConfigurationCreatedEventArgs)(FederatedAuthentication_ServiceConfigurationCreated)

    End Sub
Private Sub FederatedAuthentication_ServiceConfigurationCreated(ByVal sender As Object, ByVal e As Microsoft.IdentityModel.Web.Configuration.ServiceConfigurationCreatedEventArgs)

        Try
            Dim appCertificateName As String = System.Configuration.ConfigurationManager.AppSettings("adfsCertName")
            If String.IsNullOrEmpty(appCertificateName) Then
                Throw New Exception("ADFS_CERTIFICATE in config is empty")
            End If
            Dim store As X509Store = New X509Store(StoreName.My, StoreLocation.LocalMachine)
            store.Open(OpenFlags.ReadOnly)
            Dim col As X509Certificate2Collection = store.Certificates.Find(X509FindType.FindBySubjectName, appCertificateName, True)

            Dim cookieProtectionCertificate As X509Certificate2 = col(0)
           e.ServiceConfiguration.SecurityTokenHandlers.AddOrReplace(New SessionSecurityTokenHandler(New System.Collections.ObjectModel.ReadOnlyCollection(Of CookieTransform)(New List(Of CookieTransform)() With { _

        New DeflateCookieTransform(), _
        New RsaEncryptionCookieTransform(cookieProtectionCertificate), _
        New RsaSignatureCookieTransform(cookieProtectionCertificate) _
})))

        Catch ex As Exception
            Throw ex
        End Try
    End Sub

But I am getting following error
Error 103 'Public Shared Event ServiceConfigurationCreated(sender As Object, e As Microsoft.IdentityModel.Web.Configuration.ServiceConfigurationCreatedEventArgs)' is an event, and cannot be called directly. Use a 'RaiseEvent' statement to raise an event.
Can somebody help me in converting the code?

A: After converting your C# code to VB.net from http://www.developerfusion.com/ i got below codes from there.Just ty this.,
Private Sub Application_Start(sender As Object, e As EventArgs)
    Dim defaultTableData = New DefaultTableData()
    defaultTableData.CheckAndUpdate()
If ConfigurationManager.AppSettings("RSAConfigSwitch").ToString().ToUpper() = "ON" Then

    FederatedAuthentication.ServiceConfigurationCreated += New EventHandler(Of ServiceConfigurationCreatedEventArgs)(AddressOf FederatedAuthentication_ServiceConfigurationCreated)
End If

End Sub
Private Sub FederatedAuthentication_ServiceConfigurationCreated(sender As Object, e As Microsoft.IdentityModel.Web.Configuration.ServiceConfigurationCreatedEventArgs)
    Dim certName As [String] = ConfigurationManager.AppSettings("CertificateName").ToString()
    ' read from web.config
    Dim store As New System.Security.Cryptography.X509Certificates.X509Store(System.Security.Cryptography.X509Certificates.StoreName.My, System.Security.Cryptography.X509Certificates.StoreLocation.LocalMachine)
    store.Open(OpenFlags.[ReadOnly])
    Dim col As System.Security.Cryptography.X509Certificates.X509Certificate2Collection = store.Certificates.Find(System.Security.Cryptography.X509Certificates.X509FindType.FindBySubjectName, certName, True)
    Dim cookieProtectionCertificate = col(0)
e.ServiceConfiguration.SecurityTokenHandlers.AddOrReplace(New SessionSecurityTokenHandler(New System.Collections.ObjectModel.ReadOnlyCollection(Of CookieTransform)(New List(Of CookieTransform)() From { _
    New DeflateCookieTransform(), _
    New RsaEncryptionCookieTransform(cookieProtectionCertificate), _
    New RsaSignatureCookieTransform(cookieProtectionCertificate) _
})))

End Sub
Hope this may helpful.,

A: The compiler error tells you that there's something wrong with your event handler. VB doesn't support the += syntax for adding a handler. Use the AddHandler/AddressOf keywords instead:
   AddHandler  FederatedAuthentication.ServiceConfigurationCreated, AddressOf FederatedAuthentication_ServiceConfigurationCreated

A: A few things are off in your conversion - try this:
Private Sub Application_Start(ByVal sender As Object, ByVal e As EventArgs)
    Dim defaultTableData = New DefaultTableData()
    defaultTableData.CheckAndUpdate()

    If ConfigurationManager.AppSettings("RSAConfigSwitch").ToString().ToUpper() = "ON" Then
        AddHandler FederatedAuthentication.ServiceConfigurationCreated, AddressOf FederatedAuthentication_ServiceConfigurationCreated
    End If
End Sub

Private Sub FederatedAuthentication_ServiceConfigurationCreated(ByVal sender As Object, ByVal e As Microsoft.IdentityModel.Web.Configuration.ServiceConfigurationCreatedEventArgs)
    Dim certName As String = ConfigurationManager.AppSettings("CertificateName").ToString() ' read from web.config
    Dim store As New System.Security.Cryptography.X509Certificates.X509Store(System.Security.Cryptography.X509Certificates.StoreName.My, System.Security.Cryptography.X509Certificates.StoreLocation.LocalMachine)
    store.Open(OpenFlags.ReadOnly)
    Dim col As System.Security.Cryptography.X509Certificates.X509Certificate2Collection = store.Certificates.Find(System.Security.Cryptography.X509Certificates.X509FindType.FindBySubjectName, certName, True)
    Dim cookieProtectionCertificate = col(0)

    e.ServiceConfiguration.SecurityTokenHandlers.AddOrReplace(New SessionSecurityTokenHandler(New System.Collections.ObjectModel.ReadOnlyCollection(Of CookieTransform)(New List(Of CookieTransform) From {
        New DeflateCookieTransform(),
        New RsaEncryptionCookieTransform(cookieProtectionCertificate),
        New RsaSignatureCookieTransform(cookieProtectionCertificate)
    })))
End Sub

redpajama_set_name: RedPajamaStackExchange


text:
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New champion Ellis in Home Internationals squad
New English champion Harry Ellis (Meon Valley, Hampshire, IoW & CI) has been selected in the England squad for the Home Internationals at Glasgow Gailes Golf Club in Scotland on 15th – 17th August.
He is one of five new caps along with Seb Crookall-Nixon (Workington, Cumbria), Nathan Kimsey (Woodhall Spa, Lincolnshire), Jamie Rutherford (Knebworth, Hertfordshire), and Jordan Smith (Bowood G&CC, Wiltshire).
The rest of the squad that will defend the Raymond Trophy is: Jack Hiluta (Chelmsford, Essex), Garrick Porteous (Bamburgh Castle, Northumberland), Neil Raymond (Corhampton, Hampshire, IoW & CI), Callum Shinkwin (Moor Park, Hertfordshire), Ben Stow (Rushmore, Wiltshire) and Josh White (Chipstead, Surrey).
Ellis (image © Tom Ward), who won't turn 17 until next month, won the English Amateur Championship at Silloth-on-Solway in Cumbria last weekend, beating Lancashire's Henry Tomlinson 2 and 1 in a weather-protracted 36-hole final.
He was capped at under 16 level and although a member of the England boys squad, now steps up to a full international. A former Hampshire junior champion, this year he has finished fifth in the McEvoy Trophy and equal sixth in the South East boys qualifying.
Crookall-Nixon's selection comes just 13 weeks after he was injured in a car accident in his native Cumbria and follows his quarter final defeat by Ellis in the English Championship. The English under 16 champion in 2008 and 2009, he was also an under 16 cap and finished fourth in last year's Brabazon Trophy.
Kimsey, 19, steps up from a boy international, while he has also represented GB&I against Europe in the Jacques Leglise Trophy. Winner of the McEvoy Trophy in 2011 which saw him finish fourth in the Titleist/FootJoy English Boys Order of Merit, this year he has won the Darwin Salver and finished third in the South East of England Links Championship while reaching the semi-finals of the English Amateur.
Rutherford, 20, earns his first international call at any level having won the County Champions tournament in 2011. This year, he finished third in the Brabazon Trophy, winning the Henriques Salver for the lowest aggregate for a player aged under 20, and fourth in the South of England Open Amateur as he did last year.
Smith, 19, also earns his first international honour having been a member of the victorious Wiltshire team in last year's County Championship finals at Ganton. In successive weeks last month he finished joint runner-up in the Chiberta Grand Prix and tied fifth in the Biarritz Cup and was beaten by Ellis in the English Amateur semi-finals.
Hiluta, 23, made his full England debut against France in May, having earlier won the Spanish Amateur, while Porteous, 22, joint seventh in the Brabazon Trophy, reached the last 16 of the English Amateur.
Raymond, 26, has been an England regular since his debut against Spain in 2011. He has won the Brabazon Trophy for the past two years and just failed to add the English title last week, losing in the quarter finals. Last winter, while in Australia, he won the New South Wales Medal.
Shinkwin, 19, won all four of his games on his full England debut against France in May. A semi-finalist in last year's English Amateur, in 2012 he has won the Hampshire Hog, finished equal third on the Berkhamsted Trophy and tied fifth in the Darwin Salver.
Stow, 20, another member of Wiltshire's winning County Championship team, debuted in last year's Home Internationals and was runner-up in the County Champions tournament. He finished seventh in the Scottish Stroke Play, ninth in the Brabazon Trophy and won the individual competition at the recent European Men's Challenge Trophy in Iceland.
White, 21, was another to make his full England debut against France in May having been a boy cap. This summer, he has won the Berkshire Trophy, the Scrutton Jug for the best aggregate score from the Berkshire and Brabazon Trophies, and reached the last 16 of the English Amateur.
England has won the last three Home Internationals matches.
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redpajama_set_name: RedPajamaCommonCrawl


"Welcome to our new project - a growing archive of zines published by ScoTpress and IDIC. Zines were an important part of Star Trek fandom back in the days when you were lucky to see an episode once a week and then only for a few weeks a year. We went months without any episodes and contact between fans was mostly limited to letters, long distance phone calls and the occasional convention. As a result a number of fan writers decided to write their own stories and the fans who didn't have the gift of writing their own stories were only too keen to read any stories they could get their hands on. These stories were then printed in fanzines and distributed across fandom.
Print fanzines have been part of Star Trek Fandom's history for over 40 years. We want to honour this history by preserving these zines and by also giving more recent fans the opportunity to see what they looked like in their original print formatting.
The zines are available to download as PDFs. The PDFs have been produced by scanning the original zines and they are readable on a computer, laptop or tablet with a 8"+ vertical screen. You might struggle to read them on smaller screens.
Note - some of the individual stories from these zines have already been posted as html files where we were able to get permission from the writers. These are linked from the contents list of the zines where they originally appeared.
Click on the title to go to the index.


text:
Devils-Rangers rivalry gets boost thanks to Hughes, Kakko
By Sean LeahyJun 22, 2019, 4:04 AM EDT
VANCOUVER — Jack Hughes and Kaapo Kakko will be linked together for the rest of their careers after they were the top two picks in the 2019 NHL Draft Friday at Rogers Arena. Not only will the comparisons and debates about their play go on for years, they are now in the middle of a longtime rivalry between the New Jersey Devils and New York Rangers.
"I was thinking about that this morning. And how good is that?," said Rangers president John Davidson. "Rivalries across the river. It's going to be talked about for a long, long, long time. I think that's just the greatest. It's fantastic. I think that's what hockey needs."
The No. 1 and No. 2 selections in the draft only met for the first time before Thursday's top prospects media availability, but they'll see plenty of one another as Metropolitan Division rivals. There's no love lost when the Devils and Rangers get together, but after a few down years for the franchises this is an injection of buzz that the rivalry needed.
"They'll be linked together. I think it's great for the NHL, but it's great for us," said Devils general manager Ray Shero. "A couple years ago you had Auston Matthew and Patrik Laine. They're great players but one's in Toronto, one's in Winnipeg, they play each other twice a year. Then you've got Connor McDavid and Jack Eichel, they're great players. One's in Edmonton, one's in Buffalo, they play twice a year.
"This is kind of spicy, you know? So we look forward to it. The competition's great. … For the Rangers and Devils fans, it should be really good. That's what we're hoping for and we're hoping it's just a little bit better for the Devils."
While the talk for years will be Jack vs. Kakko, the hockey world pitting those two against one another won't be a factor that fuels Hughes to succeed.
"I don't think I need any extra motivation," said Hughes during the Stanley Cup Final. "Once you get to that level you're in the NHL. You're playing [Sidney] Crosby, you're playing [Ryan] O'Reilly, you're playing unbelievable players every night. For me, it'll just be a lot of fun to be linked with [Kakko] for a lot of years."
• New Jersey Devils take Jack Hughes with No. 1 overall pick
• Rangers select Kaapo Kakko with second overall pick
• USA Hockey big winner of Round 1
• 2019 NHL Draft tracker — Round 1
Sean Leahy is a writer for Pro Hockey Talk on NBC Sports. Drop him a line at phtblog@nbcsports.com or follow him on Twitter @Sean_Leahy.
Tags: 2019 NHL Draft, Jack Hughes, Kaapo Kakko, New Jersey Devils, New York Rangers, Connor McDavid, Jack Eichel, Jack Hughes, kaapo kakko, Patrik Laine


Summer seasons in Lyons can be sweltering! Most of us know how tough it is to sleep, work, or play while you're suffering in the sweltering heat. No person wants to breathe thick, hot air in their very own house. Call us 07 4863 4450 for prompt and reliable air conditioning repair service in Lyons.
Our very trained service specialists will make certain your A/C unit is performing at peak performance. We will rapidly and accurately diagnose and repair any faults with your system and offer maintenance contracts and suggestions in order to help you decrease your energy consumption.
There are several signs that your air conditioner system will need to be fixed. If you observe strange sounds or odors coming from your system it will need to be repaired. This could be an indication that mold and mildew is growing in the ventilation or that parts have actually gotten loose. Another sign that your system isn't really working properly is drastically lowered air flow. You could check this by switching on your Air Conditioning unit and placing your hand near the vent. If the airflow isn't really as strong as you remember this could imply you need to get your unit repaired.
Our home AC repair Lyons specialists can look into your A/C system to see what repair work need to be made. From there, we'll recommend new parts and replace any component that is causing your system to break. We could make certain your Air Conditioner kicks on when you need it to in order to maintain maximum comfort and fresh air. We've worked on many different air conditioner units throughout the years, and we're positive in our capacity to find you a service.
If you discover that your a/c unit isn't really working, give us a call. More often than not, the a/c unit has a broken part that needs to be replaced. Units that leak, blow warm air, or make a loud clanking noise need to be serviced as soon as possible. Enjoy maximum comfort once again with the help of our group.
When you decide to collaborate with us, you can be certain that you will get the most professional and cost efficient air conditioning maintenance solutions Lyons has to offer. Thanks to our superb services our clients can unwind, knowing that precautions have been taken to maintain their air conditioner system working at their absolute best. When you want the best care for your a/c unit, you could contact us at any moment for additional information about what we have to offer.
With comprehensive experience in both residential and commercial jobs, we can look after all your immediate repairs and/or scheduled maintenance work. No job is big or too small. We could collaborate with you to provide a customised, inexpensive maintenance contract to meet your ac system servicing needs. You can be assured of our dedication to professionalism and reliability, integrity, safety, excellent quality workmanship and the environment!
We collaborate with a series of makes and model a/c systems as well both split and ducted systems. No matter whether you require one a/c system installed or hundreds for your commercial or industrial complex. We prepare and available to service all your cooling requirements.
Many HEATING AND COOLING business in Lyons only service or install one brand because it is easier on their team to just learn about one system. This means that you could select in between upgrading older units that are working fine or letting your current system go without maintenance till a serious issue emerges. Fortunately for you, we service and repair most brand names so you can give us a call whatever your trouble is.
Our fast solution is exactly what we are known for, and our professional, long-lasting results are what keep our clients coming back. Our team believe in making your COOLING AND HEATING system function the way it should with little work on your part.
Our technicians have years of experience in the industry and successfully done hundreds of a/c service Lyons for commercial, industrial and domestic units. We provide unbiased advice for free that would save you money and minimize your down time. You can be certain that your a/c systems are performing at their best with us on the job.


If your child has leukemia, your child's doctors will recommend one or a combination of therapies. These can include chemotherapy, radiation therapy, and bone marrow transplantation.
Chemotherapy uses anti-cancer drugs that can be given to children intravenously, by mouth, directly into the spinal fluid, or as a shot in the leg. These medicines are distributed throughout the body through the bloodstream. They can help kill cancer cells that are in the blood and bone marrow as well as those that may have spread to other areas. Chemotherapy is the primary treatment for childhood ALL.
Children with leukemia usually receive chemotherapy for six to nine months, and all the therapy is given in the hospital. Researchers are studying new combinations of chemotherapy drugs in order to find the most effective combinations for different types of leukemia.
The first phase is called Remission Induction. Treatment during this phase is designed to kill the leukemic cells in the blood and the bone marrow, putting the disease into remission.
The second phase is Central Nervous System Directed Therapy. This phase kills cancer cells in the central nervous system and prevents the disease from spreading to the spinal fluid.
The Consolidation/Intensification phase is given after the disease is considered to be in remission. It's designed to kill remaining leukemic cells that may be inactive but could begin growing again and cause the leukemia to recur. This phase usually lasts several months.
The maintenance phase is the final phase of treatment that lasts for two to three years. It's used to kill any remaining cells that could cause a recurrence. Medications are often given at lower doses.
Leukemia can spread to other places in the body: the central nervous system or, in boys, the testicles. If there is evidence of leukemia in these areas, your child will receive chemotherapy and radiation therapy to the brain and spinal cord or testicles. All patients with leukemia receive chemotherapy directly into the spinal fluid. This is to keep the leukemia from spreading there or treat the leukemia if it is already in the spinal fluid.
Side effects of chemotherapy will be different from person to person. They can include fatigue, nausea, vomiting, diarrhea, loss of appetite, and risk of infection. Your doctor will provide medications to lessen these side effects. Be sure to ask your doctor questions about which medications are being prescribed for your child, what the side effects may be, and what interactions may occur with other medications your child may be taking.


The name of the association shall be THE NORTH DAKOTA BUILDING OFFICIALS ASSOCIATION.
The objectives of the Association shall be to advance and improve the standards of building inspection practices in the State of North Dakota, to disseminate information and experience relative to the improvement of methods, theories and regulations pertaining to building construction and zoning, to advocate and sponsor in so far as possible, the passage of more efficient building code and zoning legislation throughout the state, to elevate the standards of personnel requirements for Building Officials, to make known to the public the true nature and importance of the services performed by the Building Officials, to discourage any influence of party politics in the selection and retention of Building Officials or in the efficient and professional administration of this office, to encourage and promote good public relations and good government to municipalities, and to further the spirit of cooperation among the members.
The Association shall be in association with the North Dakota Fire Prevention Association and shall officially represent the Building Officials of the State in the activities of the North Dakota Fire Prevention Association. The Association is not organized for profit, and no part of the income shall inure to the benefit of any member or officer except as reimbursement for necessary expenses actually incurred for the Association.
Active membership shall be restricted to individuals who are Chief Enforcement Officers of Municipal Building Departments and State Agencies enforcing State Building regulations and to employees of any government department or bureau engaged in the administration or formulation of laws or Ordinances, rules or regulation, relating to buildings.
Associate membership shall be restricted to organizations or firms interested in the maintenance, promotion and improvement of the standards of buildings, housing, city planning or zoning, but not directly engaged in the sale of the building materials or equipment or methods of construction, and to individuals representing manufacturers, architects, engineers, general contractors, financial institutions, insurance companies and others engaged in the building industry directly or allied with it or former active members of this Association.
Honorary membership shall be restricted to individuals of distinction who have rendered outstanding service in the furtherance of the purposes and objectives of the Association. Honorary membership shall be conferred after presentation to the membership of the Association by the EXECUTIVE COMMITTEE and approved by a 2/3 majority of the vote of the active members present at any regular or special meeting of the Association.
Such Honorary Member's shall retain the rights and privileges of their previous class of membership, if any, and shall be exempt from the payment of any annual dues.
Life membership shall be restricted to individuals who have held a position of Enforcement Officer of Municipal Building Departments, or State Agencies enforcing State Building Regulations for a period of at least fifteen (15) years, and who shall have been an active member of the North Dakota Building Officials Association at the time of retirement or release. Retirement or Release as used here shall mean an Enforcement Officer who is no longer active on a full or part-time basis as an Enforcement Officer. Life membership shall be conferred after presentation to the membership of the Association, by the EXECUTIVE COMMITTEE, and approved by a vote of two-thirds (2/3) of the active members present at any regular or special meeting of the Association. Such Life Members shall retain the rights and privileges of their previous class of membership and shall be exempt from the payment of any annual dues.
Student Membership shall be restricted to students who are enrolled full-time in a post-secondary educational institution within the State of North Dakota; and, who are pursuing a major course of study in architecture, engineering, code enforcement, construction, or a related field. The annual dues for Student membership shall be one-half the amount of regular annual dues as established by the By-Laws of the North Dakota Building Officials Association.
Applications for each class of membership shall be made in writing and must be endorsed by an active member of the Association in good standing. A check, or cash, in the amount of the Annual Dues Fee must accompany all applications for membership.
Any member shall forfeit membership whose conduct has proven detrimental to the welfare, interest, or good name of the Association, by a two-thirds (2/3) vote of the members of the EXECUTIVE COMMITTEE. The member, if expelled, shall have the right to request a review of the action by the general membership at a regular meeting and a majority vote of the members present shall be final. . Prior to the hearing, the member shall be advised of the charges in writing. Such a vote or action shall be taken only after a hearing at which the member shall be given an opportunity to appear in his or her own defense or to reply to the charges in writing.
The Active and Life Members of the Association shall have the sole and exclusive right to vote. Active members who may become inactive as Officials, hereinbefore qualified, may continue membership on an Associate Membership status, upon payment of the annual dues, providing dues are paid within three (3) months of the current year. Any Member of the Association may introduce an item for consideration by either the Executive Committee or the entire membership.
The officers of the Association shall be active members, elected as provided in the By-Laws, and shall consist of a President, a Vice President, and a Secretary-Treasurer. The officers shall conduct business according to the North Dakota Building Officials Association By-Laws.
The terms of all officers shall end on the 31st day of December, at which time the officers elected at the annual meeting of the Association shall take office.
In the event of a vacancy in the office of the President, the unexpired term shall be filled by the Vice-President. In the event of a vacancy in the office of Vice-President or Secretary-Treasurer, the EXECUTIVE COMMITTEE shall elect, by a majority vote, a member of the Association to fill the un-expired term.
There shall be an EXECUTIVE COMMITTEE which shall be composed of the President, the Vice-President, the Secretary-Treasurer, the Past President and five active members of the Association who shall be elected. Four of the five shall be elected by REGION, and one shall be elected at large. At the initial election, members from REGIONS I AND II shall be elected to two (2) year terms and members from REGIONS III and IV shall be elected to one year terms, thereafter. REGIONAL Members shall be elected to two (2) year terms. The Member at-large shall be elected to one (1) year terms.
The EXECUTIVE COMMITTEE shall be responsible to the membership for the management of the affairs of the Association, for the promotion of the purposes of the Association, and for the meetings-of the membership. The EXECUTIVE COMMITTEE shall outline policies and present recommendations concerning matters of interest for action by the Association. The Past President of the Association shall preside as Chairman of the Committee.
Any member of the EXECUTIVE COMMITTEE who misses more than three (3) meetings during the period of one (1′) calendar year shall automatically be removed from the EXECUTIVE COMMITTEE. If an acceptable reason is given for the absence, the EXECUTIVE COMMITTEE, by a majority vote, may waive the above.
Any amendments to this Constitution may be adopted by a two-thirds (2/3) vote of the members present at any meeting of the members, provided written notice of the proposed amendments shall have been given by mail to the members at least two (2) weeks prior to the meeting.
Constitution and Amendments readopted this 1st day of March 2006.


text:
China Chevening Alumni climb mountains for humanity | Chevening
China Chevening Alumni climb mountains for humanity
In the shadow of Guizhou Province's highest peak, Chevening Alumni and future applicants from across northeast and southwest China came together for China's annual Chevening Conference from 22-23 September. Coordinated by China Chevening Alumni in collaboration with the British Consulate General Chongqing, the British Embassy Beijing and the Zoological Society of London, the conference aimed to draw attention to some of the most pressing issues faced by people, cultures, and ecosystems, both domestically and around the world.
Set in the UNESCO-listed Biosphere Reserve, Mount Fanjingshan, the conference was a weekend full of learning, discussion, and exploration. This subtropical forest region is home to the Tujia, Miao, and Dong people, as well as many endangered species. It is also a sacred site for Buddhism, dating back to the Ming Dynasty. The theme of the conference was in harmony with the surroundings, exploring issues such as the preservation of cultural heritage in ethnic minorities, wildlife protection, and the implementation of social enterprise in some of China's poorest areas.
Speakers explored issues that are close to the hearts of many of the 1,700 Chevening Scholars that are currently studying in the UK, including 66 scholars from China. One of the speakers, a headmaster from a local school, shared the challenges faced in developing an educational model that supports families subject to urban migration. Despite submitting an unsuccessful Chevening application this year, he seized this opportunity to harness the collective knowledge of conference attendees to discuss ideas to better develop education in the region, particularly in reference to the wellbeing of 'left-behind' children.
Furthermore, as this area is home to endemic populations of the golden monkey and giant salamander, speakers from the British Embassy in Beijing and the Zoological Society of London talked in depth about how the UK and China work together in tackling the illegal wildlife trade.
Finally, the delegates heard from social enterprises that bring traditional handicrafts to market, as a way of exploring strategies for regional economic development (including the positive impact of tourism) and the preservation of local cultural heritage.
To date, Chevening has broadened the horizons of over 3,500 people from China. Upon reaching the peak of Mount Fajingshan as part of the conference, scholars reflected on the impact that Chevening has had on them and others. Recognising that Chevening Scholars are selected for their passion and dedication for tackling global issues, such as those brought to light in Guizhou, the alumni concluded that the Chevening Alumni community is precious as it consists of like-minded, forward-thinking people who not only care about world issues, but have the courage to use their abilities to inspire future generations of problem-solvers, influencers, and thought leaders.
Although at times the challenges facing humanity may appear mountainous, the China Chevening Conference is testament to the collective will of the network to continue to achieve, share knowledge across regions and borders, and move forward to improve our diverse and intertwined global community.
To support and contribute toward the diversity of Chevening in China, contact the Chevening Team at the British Embassy in Beijing at [email protected]
Climate Change: What's next for Egypt?
In a year that has seen the force of nature wreak devastation in several parts of the world, including Bangladesh, the Caribbean, and Mexico, the big issue of this generation—climate change—was the topic of a Chevening Talk held by British Embassy Cairo. The event, which focussed on the greatest environmental challenges facing Egypt at the moment, […]
Namibian Alumni Bring Future Cheveners on a Hike
Last month, over 40 people took part in the 'Bring a Future Chevener Hike' in the Khomas Mountain on Farm Godeis. Organised by the British High Commission Windhoek and the Chevening Alumni Association of Namibia, the hike served as both a mentoring and information-sharing opportunity. Each alumnus was invited to bring along an individual with the potential to become a Chevening Scholar so […]
Unravelling the Creative Industry in Brunei
Last month, the Chevening Brunei Association hosted the Brunei Chevening Youth Forum 2017 at Universiti Brunei Darussalam (UBD) to provide a platform for youth to discuss emerging creative industries and their impact on the economy. The topics discussed include unravelling the creative industry, commercialising creativity, and the creative industry ecosystem exploring three areas – industry collaboration, standards, […]


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Success Stories – June 8, 2010
When the Going Gets Tough …
photo: joshua fletcher
When the real estate market was taking a beating last year along with the overall economy, Rob Kildow didn't back down.
"I like a challenge, and when the market got sketchy on us, I throttled up as much as I could go," Kildow says. "My wife, Barbara, and I have been together for 21 years, and she said last year might have been the hardest she's seen me go."
The effort paid off. Kildow ranks No. 1 this year on the Hawaii Business Top 100 Realtors, a list based on gross sales registered in MLS. His total sales in 2009 were $107.4 million.
His biggest sale last year was a "stunning" $26.25 million home that stretches over an acre of land at the Big Island's Hualalai Resort. "The only thing between it and the ocean is the signature 17th green on the Hualalai golf course," Kildow says. That was the second-most expensive sale in Hawaii last year, exceeded only by the sale of Kauai's "Tara Plantation" (see next page "2009's Biggest Deal").
Kildow and his company, Hualalai Realty, deal exclusively within the luxurious Hualalai Resort, a Four Seasons resort owned by computer magnate Michael Dell. The resort recently completed a $40-million renovation and is stacked with multimillion-dollar homes along 65 acres of the Big Island's Kohala Coast.
"You need a real solid foundation to weather the market we are currently experiencing … and, fortunately, we've got a lot of things we can sell off of here," Kildow says.
That includes six restaurants, two golf courses, two workout facilities, a spa, a pool, two beach clubs, a five-diamond Four Seasons Resort and an ocean-activity program at the nearby beach. "I get a lot of ammo to use," Kildow says.
He also attributes his success to a combination of other factors, including "great coverage" from national and global media that are attracted by Hualalai's luxurious amenities; the "prequalified prospects" he gets from the Four Seasons Resort; and the referrals he gets from previous clients.
"The referrals we get from our current owners are the most effective, because they've already done it, they've purchased here. So they are talking with their friends and colleagues, wherever their primary homes might be, saying, 'You should go to Hualalai. We think it's wonderful.' Those people have already voted with their checkbooks, and that's a more compelling story than some article in Spa Magazine."
Some Hawaii families have getaway homes at Hualalai, he says, but the majority of his customers are Mainlanders.
"In the beginning, it was heavily weighted to the West Coast, and within the West Coast to California, but in the last few years our range has really picked up," Kildow says. "I think we have 26 to 28 states represented here and five different countries."
Kildow was not even on last year's Top 100 Realtors list because the resort's sales were not previously reported to MLS, which is the basis for the rankings.
So far, he says, 2010's sales have been a continuation of a "very good last five months of 2009" for the resort and himself.
"We've now put eight very solid months together, and as long as we can keep that up, we're going to be very happy. And I don't see any outward signs of that diminishing, but you can rest assured we're not taking anything for granted."
Kildow says he doesn't expect real estate prices in general to shift very much over the next couple of years, in part because construction prices have decreased, which could keep prices down for people trying to resell homes.
"I think anyone who expects any real appreciation over the next few years is probably going to be disappointed," Kildow says. "I think there is still enough inventory out there, and we're just trying to get a real firm floor established, and I know others in other price groups are trying to do the same."
Kildow has come a long way since selling his first house – to a third cousin for $36,000 in 1976 in Olympia, Wash.
"I can barely remember it," Kildow says with a laugh. "It was a long time ago. But other times it feels like it was a few years ago, because my career has gone very quickly. I've done practically all the things one can do in the real estate business."
Though grateful to be recognized as Hawaii's No. 1 Realtor, he repeatedly gives credit to his team. When the initial figures for the Top 100 Realtors were compiled, MLS data listed Kildow with $210 million in sales, but he graciously told Hawaii Business that his colleagues were responsible for half of those sales.
"I am so fortunate to have a team that shows up every day," Kildow says. "Because this is like the World Series every day. People come in here and expect an extremely high level of service and information, and everybody delivers it."
Kildow also attributes his success to Hualalai itself. He and Barbara moved there in 2001 and he began working for the resort in December 2003.
"My wife and I have traveled a lot, and I meet people who are very well-traveled. I tell people, if they ever come across a place that you feel has Hualalai beat, you call because Barbara and I will be there in 48 hours. And guess what? The phone has never rung on that one."
Meeting Cher
When you have been in the real estate business as long as Rob Kildow, you have met a lot of interesting people and have great stories to tell. One of Kildow's favorites is how he helped Cher sell a home that she had bought and spent a lot of money upgrading.
"Meeting Cher was fun," Kildow says. "I'd swung by the home just to check how work was progressing because it wasn't yet complete. I hadn't met Cher, but I knew she was the investor behind it.
"There was a group of three people there and I recognized who I thought was her and she got up and said, 'Who are you?' And I said, 'My name is Rob. I'm the director of sales here.'
She said, 'Oh, my name is Cher,' and I said, 'Yeah, I figured that much out."
Referrals, Knowledge, Low-Pressure
By Mark Brislin
Real estate is mainly a referral business, and Neal Norman knows that happy clients will keep referrals coming.
"Our business is such a referral-based business that we say, 'If you screw up on a little island like Kauai, you're not going to be able to do business here,' " says Norman, an agent with Koa Properties on Kauai and No. 2 statewide on the Hawaii Business Top 100 Realtors. His total sales in 2009 were $76.88 million.
Norman describes his style as high-integrity honesty and low-pressure sales combined with "extreme local knowledge and professionalism." The properties on Kauai are so beautiful that they sell themselves, he says, so the agent's primary job is to present opportunities to buyers and sellers and have the insight and foresight to find the right match between the two.
"There are no high-pressure sales, it is all very local, akamai and casual," Norman says. "Some of our best deals have been made out surfing in Hanalei Bay on a board talking friend to friend about a property."
Norman's 2009 numbers were bolstered by the sale of a $13.5-million, 7.5-acre bluff-front home overlooking Secret Beach on Kauai's North Shore. He also had a successful 2008, but sold more land that year than homes, and did not make the Hawaii Business Top 100 Realtors list because land sales are not counted.
Norman says most of Koa Properties' clients are "second-home, Californian, high-net-worth individuals," who Koa attracts with its access to unlisted properties.
He says the real estate market on Kauai right now is very strong, driven by prices on high-end homes that are 30 percent lower than the 2005-2006 peak. He attributes his recent success to a combination of "gems" available for reasonable prices, persuading sellers to be realistic about their expectations, and linking buyers with the right properties.
Koa Properties also spent a lot of money upgrading its Web site, which Norman says gives "a bigger bang for your buck. You get your message out to a lot more people for a better price point on the Web, and the ability to get massive amounts of information out there."
In a weak economy, Norman says, he takes things slower with buyers because there are more choices available. "We act with much more patience, but in a strong economy, there would be a sense of urgency. There'd be a fire lit under a client to buy, to make offers. In this economy, it's more like: Let the seller come to the buyer, instead of the buyer running after the seller."
2009's Biggest Deal
By Jon Letman
When Tara Plantation on Kauai's east side sold in November, the 174-acre beachfront property had been listed for 1,927 days – more than five years. At $28 million, the sale was Hawaii's priciest residential real estate transaction in 2009.
The sprawling property, tucked out of sight between the Anahola Mountains and Papaa Bay, originally listed in 2004 for $46.5 million. Even though Hollywood executive Peter Guber and his wife, Tara, had to cut the price drastically to sell it, they still received four times what they paid for it in 1998.
photo courtesy: Papa'a Bay Ranch
Representing the buyer was Hannah Sirois of Kauai Heritage Properties, while the listing agents were John Ferry, Malia Powers and Barbara Sloan of Coldwell Banker Bali Hai Realty. Despite speculation about a "Hollywood buyer" or development acquisition, Sirois says, Papaa Bay Ranch (as it's again called) was purchased by a noncelebrity, "professional couple" who aspire to own a property that allows them to "restore, recuperate and enjoy the magic of the island."
The wooded, rambling estate was owned by Kauai's Rice family, and then the Gerbode Trust for most of the 20th century. Before Hurricane Iniki, it was sought by Michael Jackson and Elizabeth Taylor, but sold to an Idaho rancher in the mid-1990s. In 1998, Guber bought it and incorporated authentic Hawaiian architecture, adding two 4,000-square-foot guest houses, a pool, horse stables, a yoga studio and a caretaker's house alongside the 13,154-square-foot, plantation-style home.
Sirois says the undulating property is criss-crossed with trails and has a meadow that abuts an idyllic sandy beach. "This is an extraordinary property," she says. "It's beautiful, just beautiful."
Stores Flourish in an Online World
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House of Finance, Inc.
2020 HB Industry Spotlight – January 7, 2020
West Oʻahu Magazine 2020
Leadership – December 2, 2019
2019 CEO of the Year: Bettina Mehnert of AHL
Success Stories – November 4, 2019
Hawaiʻi's Most Charitable Companies 2019


What Candy Is Your State Stocking Up On This Halloween?
Which state is devoted to Hershey's Kisses? Where do Skittles reign supreme? Just in time for Halloween, Candystore.com has reported its top-selling candies by state.