Count de Money: What Are the Costs of Cancer ? (American Cancer Society Cancer Facts & Figures 2002-2013)

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What Are the Costs of Cancer?
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National Institutes of Health (NIH) estimates:
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overall costs of cancer:
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2010 – $263.8 billion (2011)
2010☝$263.8 billion (2010)

2008👇$201.5 billion (2013)
2008☝$228.1 billion (2009)
2007☝$226.8 billion (2012)
2007☝$219.2 billion (2008)

2006👇$206.3 billion (2007)
2005☝$209.9 billion (2006)
2004☝$189.8 billion (2005)
2003☝$189.5 billion (2004)
2002☝$171.6 billion (2003)
2001☝$156.7 billion (2002)

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direct medical costs
(total of all health expenditures)
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2010 – $102.8 billion (2011)
2010☝$102.8 billion (2010)

2008👇$77.4 billion (2013)
2008👇$93.2 billion (2009)
2007☝$103.8 billion (2012)
2007☝$89.0 billion (2008)
2006☝$78.2 billion (2007)
2005☝$74.0 billion (2006)
2004☝$69.4 billion (2005)
2003☝$64.2 billion (2004)
2002☝$60.9 billion (2003)
2001☝$56.4 billion (2002)

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2008-2011 – indirect morbidity costs
(cost of lost productivity due to illness)
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2010 – $20.9 billion (2011)
2010☝$20.9 billion (2010)
2008☝$18.8 billion (2009)
2007☝$18.2 billion (2008)
2006☝$17.9 billion (2007)
2005☝$17.5 billion (2006)
2004☝$16.9 billion (2005)
2003☝$16.3 billion (2004)

2002👇$15.5 billion (2003)
2001☝$15.6 billion (2002)
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indirect mortality costs
(cost of lost productivity due to premature death)
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2010 – $140.1 billion (2011)
2010☝$140.1 billion (2010)
2008☝$124.0 billion (2013)

2008👇$116.1 billion (2009)
2007☝$123.0 billion (2012)
2007☝$112.0 billion (2008)

2006👇$110.2 billion (2007)
2005☝$118.4 billion (2006)
2004👇$103.5 billion (2005)
2003☝$109 billion (2004)
2002☝$95.2 billion (2003)
2001☝$84.7 billion (2002)

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According to US Census Bureau:
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Americans uninsured
2012-2013 had no health insurance coverage
——————————————————————
2010👇approximately 50 million (2013)
2009 – almost 51 million (2012)
2009☝almost 51 million (2011)
2008☝46 million (2010)
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2008 – approximately 28% aged 18 to 34 years (2010)
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2010👇almost one-third of Hispanics (31%) (2013)
2009 – almost one-third of Hispanics (32%) (2012)
2009☝almost one­-third of Hispanics (32%) (2011)
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2011-2012 (17 years of age and younger)
2010-2012had no health insurance coverage
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2010 – one in 10 children (2013)
2009 – one in 10 children (2012)
2009 – one in 10 children (2011)
2008 – 10% of children (2010)
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2012-2013 PLEASE NOTE:

These numbers are not comparable to those published in previous years as of 2011, NIH calculating estimates using different data source:

2012 – NIH is using a different data source:

2012-2013 Medical Expenditure Panel Survey (MEPS) of the Agency for Healthcare Research and Quality

2012-2013 MEPS estimates based on more current, nationally representative data used extensively in scientific publications

2012-2013 direct and indirect costs will no longer be projected to current year, estimates of indirect morbidity costs discontinued

2012-2013 For more information, please visit nhlbi.nih.gov/about/factpdf.htm.
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Lack of health insurance and other barriers prevents many Americans from receiving optimal health care
——————————————————————
2008 – early release estimates from National Health Interview Survey (2009)
2006 – early release estimates from the National Health Interview Survey (2008)
2004National Health Interview Survey data (2007)
2003National Health Interview Survey data (2006)
——————————————————————
2008 – about 24% aged 18 to 64 years (2009)
2006☝about 24% aged 18-64 (2008)
2004 – about 17% younger than age 65 had no health insurance coverage (2007)
2003☝about 17% younger than age 65 have no health insurance coverage (2006)
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2004 – 27% 65 and older had Medicare coverage only (2007)
2003☝24% 65 and older have Medicare coverage only (2006)
——————————————————————
2008 – 13% of children had no health insurance coverage for at least part of past year (2009)
2006☝13% of children had no health insurance coverage for at least part of past year (2008)
——————————————————————
2008 – More than 36% of adults who lack high school diploma were uninsured in past year (2009)
2006☝Almost 34% of adults who lack high school diploma were uninsured in past year (2008)
——————————————————————
2008 – 23% of high school graduates (2009)
2006☝23% of high school graduates (2008)
——————————————————————
2008👇14% of those with more than high school education (2009)
2006 – 15% of those with more than high school education (2008)
——————————————————————
2008 – Lack of health insurance is not only a concern of unemployed; almost one-quarter of employed individuals (aged 18 to 64 years) were uninsured sometime during past year (2009)
——————————————————————
2004 – Persons in lowest income group 10 times as likely as persons in highest income group not to receive needed medical care because of cost (2007)
——————————————————————
2004 – Almost 16 million citizens (6%) were unable to obtain needed medical care due to cost (2007)
——————————————————————
2003 – In survey, nearly 20% aged 18-44 years reported not having usual place to go for medical care (2006)
——————————————————————
2010-2013 – Uninsured patients and ethnic minorities substantially more likely to be diagnosed with cancer at later stage, when treatment can be more extensive and more costly
——————————————————————
2012-2013 – For more information on relationship between health insurance and cancer, see Cancer Facts & Figures 2008, Special Section, available online at cancer.org/statistics.
2010 – cancer.org.
2009 – (5008.08), Special Section, available online at cancer.org.
2008 – see special section page 22

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REFERENCES:
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2013:
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http://cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-036845.pdf
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2012:
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http://cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-031941.pdf
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2011:
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http://cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-029771.pdf
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2010:
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http://cancer.org/acs/groups/content/@nho/documents/document/acspc-024113.pdf
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2009:
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http://cancer.org/acs/groups/content/@nho/documents/document/500809webpdf.pdf
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2008:
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http://www.oralcancerfoundation.org/facts/pdf/worldcancer.pdf
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2007:
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http://cancer.org/acs/groups/content/@nho/documents/document/caff2007pwsecuredpdf.pdf
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2006:
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http://cancer.org/acs/groups/content/@nho/documents/document/caff2006pwsecuredpdf.pdf
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2005:
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http://cancer.org/acs/groups/content/@nho/documents/document/caff2005f4pwsecuredpdf.pdf
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2004:
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http://www.pink-ribbon-pins.com/CancerRates2004.pdf
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2003:
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http://www.whyquit.com/studies/2003_ACS_Cancer_Facts.pdf
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2002:
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http://www.uhmsi.com/docs/CancerFacts&Figures2002.pdf
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Critiquing: Families run out of hope, money after cancer treatments (USA TODAY NEWS, NATION, Liz Szabo, USA TODAY)

USA TODAY
Liz Szabo
Michael Stravato
Jerry Mosemak
Robert Hanashiro

Before you write a Hack Piece
Check Your Facts Please

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20131118-084404.jpg
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The 3rd, and thankfully final segment of USA TODAY’s “hit-piece” of irresponsible yellow journalism about Dr. Stanislaw R. Burzynski [1], contains the following:
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“Patients stay in hotels while visiting him”
——————————————————————
Pete Cohen made this movie about his and
Hannah Bradley’s trip to the Burzynski Clinic

It does NOT look like they stayed in a hotel [2]
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The article continues:
——————————————————————
“If children deteriorate, they often end up in the closest emergency room, said physician Jeanine Graf, director of the pediatric intensive care unit at Texas Children’s Hospital in Houston, who says she has treated at least a dozen of Burzynski’s patients
——————————————————————
In the 2nd segment of USA TODAY’s yellow journalism “hit-piece,” the reader was advised that Burzynski had treated [3]:
——————————————————————
“ . . . more than 8,000 patients since 1977.”
——————————————————————
Physician Jeanine Graf, “says she has treated at least a dozen of Burzynski’smore than 8,000 patients,”

This means that Dr. Graf has treated LESS THAN 0.15% of Burzynski’s patients
——————————————————————
The article indicates that:
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“Typically, Graf sees Burzynski’s patients after they have become unresponsive, unable to open their eyes or breathe on their own”

“Graf says she’s never seen Burzynski attending to them”
——————————————————————
Why would she ?

Does she ride in the ambulance to and from the clinic ?

As the article makes clear:

“While Burzynski often meets patients on their first trip to the clinic, Jaffe said he is

“not the treating physician of the clinic’s patients”

“The doctors on Burzynski’s staff have admitting privileges at local hospitals and “attend to patients as needed,” Jaffe said”
——————————————————————
And she continues:
——————————————————————
“And describing her personal experience with Burzynski’s patients, Graf says,”

“I’ve never seen one survive long-term.”
——————————————————————
Are we supposed to believe that pediatric physician Jeanine Graf keeps track of the “more than 8,000 patients” that the article claims Burzynski has treated ?
——————————————————————
Continuing on, the article also claims:
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“The unlucky ones end up broke, spending everything on medicine, airfare, hotel rooms and meals while in Houston, Graf says

“Burzynski’s attorney, Richard Jaffe, notes that all cancer care is expensive”

“I think the clinic’s policies are a lot more charitable than the big institutions,” Jaffe says”
——————————————————————
6/25/2013 – Medical Bills Are the Biggest Cause of US Bankruptcies [4]

“Bankruptcies resulting from unpaid medical bills will affect nearly 2 million people this year—making health care the No. 1 cause of such filings . . . according to new data”

“. . . estimates that households containing 1.7 million people will file for bankruptcy protection this year

“Even outside of bankruptcy, about 56 million adultsmore than 20 percent of the population between the ages of 19 and 64—will still struggle with health-care-related bills this year . . .”

“Despite the anticipated 2013 dip, such bankruptcies represent about three out of every five filings
——————————————————————
2007 – How Many Americans Go Bankrupt Due to Medical Purposes Each Year? [5]

“2007, a Harvard study shows that at least 60% of bankruptcies are related to medical bills

“Even people with health insurance are filing bankruptcy”

“Insurance premiums, deductibles, co-pay, and out of pocket expenses cause medical bills to drown individuals and families in medical debt”

“Harvard also discovered that 75% of those filing bankruptcy for medical reasons had health insurance

“It is clear that having health insurance is no guarantee against carrying debt related to health care”
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Burzynski has treated more than 8,000 patients since 1977

8,000 divided by 36 years equals an average of:

222 patients per year

Burzynski is obviously NOT the problem
——————————————————————
Liz Szabo, Michael Stravato, Jerry Mosemak, and Robert Hanashiro

Don’t quit your day jobs

USA TODAY needs to generate readership somehow !!!
——————————————————————
Sarcasm . . . deal with it
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REFERENCES:
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[1] – 11/15/2013
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http://www.usatoday.com/story/news/nation/2013/11/15/jeanine-graf-cancer-children/2994675/
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[2]Hannah’s Anectdote:
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[3] – 11/16/2013 – Critiquing: Doctor accused of selling false hope to families (USA TODAY NEWS, NATION, Liz Szabo, USA TODAY):
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https://stanislawrajmundburzynski.wordpress.com/2013/11/16/httpwww-usatoday-comstorynewsnation20131115stanislaw-burzynski-cancer-controversy2994561/
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[4] – 06/25/13 2:29 PM ET—By CNBC’s Dan Mangan @danpostman
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http://www.cnbc.com/id/100840148
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[5] – 2007 – Written by James Hirby | Fact checked by The Law Dictionary staff
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http://thelawdictionary.org/article/how-many-americans-go-bankrupt-due-to-medical-purposes-each-year/
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20131116-002818.jpg

[11] – 1994 (3/23/1994) – Dr. Mario Sznol to Burzynski [2 pgs.]

This page is linked to:
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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 Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies
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https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
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[11] – 1994 (3/23/1994) – Dr. Mario Sznol to Burzynski [2 pgs.]
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Department of Health and Human Services, Public Health Services, National Institutes of Health, National Cancer Institutes

Dear Dr. Burzynski,

As you know, the NCI-sponsored trials of antineoplastons have been initiated and some patients have been enrolled

However, a great many more have sought access to the trial but have not been allowed to participate because of their inability to meet all the eligibility criteria

Because of this, there is strong interest on our part and that of the investigators to broaden the eligibility criteria

While we recognize the need for and value of clear eligibility criteria, we believe that the protocol now excludes some patients who would otherwise be good candidates for the trial

Specifically, we would propose the following changes in the eligibility criteria:

1. Change the allowable Karnofsky performance status from 70 to 60, as originally written in the protocol

2. Change the exclusion for size of tumor from greater than 5 cm to greater than 8 cm

3. Drop the exclusion for multifocal tumors or leptomeningeal spread

By keeping the performance status score at 60 as a requirement for entry, we believe that the protocol will still be safe for patients, and the drug will get a fair test for antitumor efficacy

We have noted that your protocols for adults (copies of which you have provided to CTEP) have similar eligibility criteria to those proposed above (ie, KPS of 60 required and no exclusion for size of tumor, multifocal tumor, or leptomeningeal spread)

We have also noted that some patients eligible for treatment on NCI-sponsored protocols appear to have been told by your staff that they could receive the antineoplastons at your institute

They have asked us the obvious question, that is, if you have enough evidence of efficacy to offer the antineoplastons as treatment to those patients, why is it that they would not be good candidates for a protocol attempting to determine and confirm the antitumor activity of the agent?

We would appreciate any help you might give us in responding to these inquiries

Pg. 2

Mario Sznol, M.D., Head, Biologics Evaluation Section, Investigational Drug Branch,Cancer Therapy Evaluation Program, Division of Cancer Treatment,
National Cancer Institute

cc:

David Parkinson, M.D.
Mike Friedman, M.D.
Dale Shoemaker, Ph.D.
Jay Greenblatt, Ph.D.
Dean Mouscher, BRI
Mary McCabe
Samuel Broder, M.D.
Bruce Chabner, M.D.
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1994 (3/23/1994) – Dr. Mario Sznol to Burzynski [20] (2 pgs.)
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[9] – 1993 (11/2/1993) – Dr. Michael A. Friedman to Burzynski

This page is linked to:
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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 Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies
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https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
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[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

Pg. 2

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

This should be sufficient to assure that the conduct of the study is satisfactory

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

Pg. 3

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

cc:

Dr. Samuel Broder
Dr. Jan Bruckner
Dr. Bruce Chabner
Dr. Jay Greenblatt
Dr. Joseph Jacobs
Dr. Mark Malkin
Ms. Mary McCabe
Dr. David Parkinson
Dr. Mario Sznol
Ms. Dorothy Tisevich
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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 (11/2/1993) – Dr. Michael A. Friedman to Burzynski [24]
1993 (10/13/1993) – Burzynski to Dr. Michael A. Friedman
1993 (10/26/1993) – Burzynski to Dr. Michael A. Friedman
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[8] – 1993 (10/26/1993) – Burzynski to Dr. Michael A. Friedman

This page is linked to:
=====================================
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 Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
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[8] – 1993 (10/26/1993) – Burzynski to Dr. Michael A. Friedman
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Dear Dr. Friedman,

In response to your letter of 10/20/1993, it is difficult for me to understand why the entire 1st page of your letter is used to discuss the simplest issue:

that adults should use a different dosage than that used for children

Since you agreed to the study procedure of Protocol BT-6 as recommended in my letter of 6/9/1993, we have not requested any changes in the structure of treatment which was accepted by Memorial-Sloan-Kettering Cancer Center (MSKCC)

As you confirmed in your letter of 10/20/1993, you know very well that since 4/1/1993 of this year my recommended dosage of Antineoplaston AS2-1 for adults is 0.4g/kg/24h

Again, I confirmed that this is the right dosage for adults in my letter to Dr. Shoemaker of 8/24/1993

Yet, for no apparent reason, you insist on using in the adult treatment protocol the dosage 0.6g/kg/24h which I recommend for children

It is generally known that a child’s body weight is much lower than that of adults

This should be reflected in the escalation of the dosages

My recommendation as to how to escalate the dosages for adults was submitted to the NCI on 6/4/1992

Yet, for no apparent reason the MSKCC protocol, which is designed for adults, escalates the dosages in the small increments recommended for children

The principle behind dose escalation is to accomplish the maximum dosage in 3 to 5 days, not 3 to 4 weeks, which would expose the patient to the unnecessary risk of tumor progression

I appreciate very much that you have finally decided to follow my recommendation regarding dosage and dosage escalation

Regarding the number of patients to be treated at MSKCC, the contradictory, incomplete, and inconsistent information is being supplied by you

The MSKCC’s protocol of 4/16/1993, 7/13/1993, and 8/30/1993 describe the treatment of 35,

Pg. 2

but not 70 patients

(please see paragraph 12.1, pg. 10 of the protocol, which is attached)

It was our understanding that 35 patients would be treated at MSKCC and at the Mayo Clinic

I never agreed for the treatment of 70 patients at MSKCC

Since I have to produce the medicine for the trial and pay for it, it is vitally important to me to know how many patients will be treated

The treatment of an additional 35 patients may cost up to 2 million dollars

Contrary to the information given by NCI that we received the money for the production of medicine, this money went apparently into a “black hole”

(“Black Holism,” The Village Voice, 7/29/1993, enclosed)

We have received none of the money which the Office of Alternative Medicine gave to the NCI for funding the trials with our medicine

Contrary to the opinion expressed in your letter, we see no reason for modifying Fleming’s Phase II clinical trial design and introducing more stringent than usual criteria for response evaluation

We request that Fleming’s original design be used, which calls for the initial treatment of 15 patients with at least one responder, instead of 20 patients and 2 responders

Given the fact that there is no existing treatment effective in this type of cancer, one responder in 15 is certainly significant and would be reason enough to expand the trial

I found your your requirement for 14 days to complete scans and laboratory tests prior to treatment very interesting

It is a very well known fact that glioblastoma multiforme is such an active tumor that if 2 weeks elapses from the time of the scan and the beginning of treatment, the tumor may increase by more than 50%

This means that even before the patient begins treatment, he can be classified as an increasing disease case

In most of the hospitals in the U.S., including out tiny clinic, all pretreatment tests including the scans can be done in one day

Therefore, I insist that the pretreatment evaluation, including brain scans, be done within 7 days from the time treatment begins

Regarding the Karnofsky Performance Status (PS), it is unclear to me why you have backed off from your own recommendation in your letter of 5/5/1993 (copy attached) that “patients with Karnofsky PS of below 70% should be excluded”

I am requesting that as recommended by NCI, the patient’s PS should be 70% to 100%

I agree that both scan data and neurological assessment can be described in the analysis of response, but the decision of how to classify response should be based on tumor measurements alone

All of these patients will have been extensively treated before

As the result of previous neurotoxic treatments, a number of these patients will deteriorate neurologically even if the Antineoplastons eradicate the

Pg. 3

tumor

The purpose of the protocol is to evaluate the antitumor effect, not to prove that Antineoplastons can repair brain damage resulting from chemotherapy and radiation

In this 1st independent study with Antineoplastons, in order to assure that patients will derive the most benefit from the treatment, it is critically important to schedule more frequent evaluations of the data than waiting until after the accrual of 14 patients, i.e. waiting 9 months

(Based on an accrual of 2 patients per month, if we wait until 14 patients are accrued and treated, 9 months will pass before the 1st evaluation takes place)

Therefore, I request that reviews of the studies be performed after the treatment of each group of 5 patients, i.e. after 6 months

I agree, however, that you will provide the Theradex printout to us as you receive it

In addition to patient welfare, there is another reason for more frequent patient evaluations

As you stated in your letter, I have no doubt that the investigators at MSKCC have extensive experience treating glioma

However, MSKCC is known to be biased against Antineoplastons

At least 3 researchers associated with MSKCC published willful misrepresentations and distortions about Antineoplaston research

Because of the controversial nature of the upcoming Antineoplaston clinical trials, it is essential that they are conducted in a manner beyond any suspicion of bias

Contrary to the opinion expressed in your letter, NCI is responsible for the trial’s delay

As you well know, the NCI selected an MSKCC investigator in 9/1992

In spite of our repeated requests, 8 months were waisted before the NCI produced the 1st draft of the protocol

As promised in my letter to you of 11/11/1992, the supply of Antineoplastons has been prepared and was shown to Ms. Mary McCabe of NCI during the site visit on 2/9/1993

The medicine was ready to be released pending final approval approval of the labels by the FDA and our final QC inspection

The medicine will be sent to you immediately once you make the corrections to the protocol that we have requested

Since you mentioned that patient recruitment has begun already, I would be glad to accept these patients immediately under my care and offer them free medicine as we wait for the protocol to be revised and the treatment at MSKCC to begin

The MSKCC protocol in its current form would threaten the welfare of these patients

In your letter you stated that your mission is to find and develop better therapies for cancer patients, and that your only obligation is to those patients

However, the way

Pg. 4

you proceed leads me to question that for the following reasons:

1) Out of numerous cancer treatment centers, you selected 2:

MSKCC and Mayo Clinic, which are known to be strongly biased against alternative treatments

In the past doctors associated with MSKCC have voiced strong opposition to Antineoplaston therapy and have published articles full of misrepresentations and distortions

2) The protocol approved by you will allow the disease to progress between the pretreatment evaluation and the beginning of treatment

3) Due to the slow escalation of dosages, patients will most likely have marked increase of tumor size beginning the treatment at the correct dosage level

4) In spite of my numerous requests (letters of 4/29/1993, 6/9/1993, and 8/24/1993) to proceed following the guidelines of the NCI’s Decision Network on 12/2/1991 to have a separate clinical trial for glioblastoma multiforme and anaplastic astrocytoma, you continue to combine both types of tumors together

Even in your most recent stratification strategy submitted to the FDA, you are planning to treat initially 20 patients without specifying whether those 20 patients are per each stratum (glioblastoma vs. anaplastic astrocytoma), or whether this initial group of 20 patients consist of a mixture of glioblastoma and anaplastic astrocytoma

If the latter is the case, then we can expect that among these 1st 20 patients, most will have glioblastoma, which is more common and more difficult to treat

In case of treatment failure in these 20 patients, it will be easy to make the statement that Antineoplastons do not have therapeutic effect in both tumor categories

5) The protocol now states in paragraph 10.2, 10.3, and 10.4 that the objective decrease of tumor size is not enough to be considered a true response to treatment, that there must also be improvement in neurological function

As I explained in my letter of 10/13/1993 to Dr. Greenblatt, it is not unusual in my practice to see patients whose tumor has disappeared, but who have deteriorated neurologically as the result of delayed toxicity from radiation therapy and chemotherapy

Since these patients in the MSKCC study have been pretreated, and since there has been no indication that anything, including Antineoplastons, can repair brain damage caused by chemotherapy and radiation, I request that the criteria including restored neurological functioning be removed from paragraphs 10.2, 10.3, and 10.4 of the protocol

Pg, 5

6) Finally, by limiting our access to the data and not allowing review until after the 1st 14 patients have been treated, it would be easy to deviate from the protocol and supply inadequate treatment, and then claim that due to the the failure of the 1st 14 patients it would be a waste of the taxpayers money to proceed with further treatment

Your final statements that you are ready to proceed with the treatment with Antineoplastons without our participation caught me by surprise

It is hard to imagine that a Federal employee would consider patent infringement, thus infringing on the patent rights of thousands of our shareholders

Once again, I urge you to take our requests seriously, honor the guidelines of the NCI’s Decision Network on 12/2/1991, and make proper corrections to the protocol, so that objective clinical studies can begin immediately

In the meantime, I would be glad to treat for free all the patients presently recruited, and will submit progress reports weekly for the NCI’s review and evaluation

SRB/cf

cc:

Senator Joseph Biden
Senator Barbara Boxer
Senator Dianne Feinstein
Senator Tom Harkin
Senator Barbara Mikulski
Congressman Berkley Bedell
Congresswoman Nancy Pelosi
Dr. Samuel Broder
Dr. Jan Buckner
Dr. Bruce Chabner
Dr. Daniel Eskinazi
Dr. Jay Greenblatt
Dr. Joseph Jacobs
Dr. Mark Malkin
Ms. Mary McCabe
Dr. David Parkinson
Dr. Mario Sznol
Ms. Dorothy Tisevich
======================================

======================================
1993 (10/26/1993) – SRB to [5]
1993 (10/26/1993) – SRB to [14]
1991 (12/2/1991) – guidelines of the NCI’s Decision Network [5 Pgs.]
1992 (6/4/1992) Burzynski to NCI
1992 (9/1992) – NCI selected MSKCC investigator
1992 (11/11/1992) – Burzynski to Dr. Michael A. Friedman
1993 (2/9/1993) – NCI Mary McCabe site visit
1993 (4/1/1993) –
1993 (4/16/1993) – MSKCC protocol
1993 (4/29/1993) – Burzynski to
to proceed following the guidelines of the NCI’s Decision Network on 12/2/1991
1993 (5/5/1993) – Dr. Michael A. Friedman to Burzynski
1993 (6/9/1993) – Burzynski to
to proceed following the guidelines of the NCI’s Decision Network on 12/2/1991
1993 (7/13/1993) – MSKCC protocol
1993 (7/29/1993) – “Black Holism,” The Village Voice
1993 (8/24/1993) – Burzynski to Dr. Dale Shoemaker
to proceed following the guidelines of the NCI’s Decision Network on 12/2/1991
1993 (8/30/1993) – MSKCC protocol
1993 (10/20/1993) – Dr. Michael A. Friedman to Burzynski
======================================