TMB files 200+ pages of charges against Burzynski

A stunning 202-page legal brief released by the Texas Medical Board last week revealed the scope of charges that have been filed against the Houston cancer quack Stanislaw Burzynski. The charges, which are dated 8 July, focus on the “care” given by Burzynski and his staff to seven anonymous patients.

The charges range from the unbelievable to the obscene:

Board Staff alleges that Respondent created a medical practice model based on marketing his proprietary anti-cancer drugs to patients without adequate measures for patient safety and therapeutic value. Respondent misled patients knowingly by promoting these drugs as an attraction to bring patients to his medical practice when Respondent was aware that he could not legally include most of those patients in FDA-approved Phase 2 clinical trials of his proprietary anti-cancer drugs. Respondent further misled patients into paying funds as a retainer prior to receiving any evaluation, diagnosis or treatment. Respondent further misled patients into (1) paying exorbitant charges for drugs and medical services; (2) accepting care from unlicensed persons while Respondent and Respondent’s employees misrepresented those unlicensed persons to be licensed medical doctors in Texas and the United States of America; and (3) accepting care from health care providers who had little advanced education or training related to cancer treatment while Respondent and Respondent’s employees misrepresented those health care providers to be doctors with significant advanced education or training related to cancer treatment.

Skeptics had long ago come to a very similar conclusion, but this betrayal of trust goes far beyond anything that researchers on the outside could have surmised.

Among the most surprising revelations was that Burzynski is being charged with misrepresenting the status of many of his medical staff as licensed physicians, when they were in fact not licensed anywhere in the United States. Many many of these accused impostors in this brief have been mentioned in the patient stories gathered by the Skeptics for the Protection of Cancer Patients. Take “Dr.” Tolib Rakhmanov who was named by the TMB:

“Respondent [Burzynski] was responsible for the false, misleading and deceptive representation to Patient A and Patient A’s fiancée that Tolib Rakhmanov was a medical doctor licensed to practice medicine in the state of Texas.”

Rakhmanov was described as “Dr. Rakhmanov” in the story of Claire Faulkner (deceased). Rakhmanov comes up more than once in this woeful litany of charges. “Dr.” Sheryll Acelar appears in far more stories gathered by the SPCP: including those of Laura Hymas (deceased), Brynlin Sanders (deceased), Evan Wolfe (deceased), Kenneth H. Jones (deceased), Maryn Cella (deceased), and others. To give a sense of the comprehensiveness of this document, the TMB charges that make-believe doctor Sheryll Acelar practiced medicine without license or training under Burzynski on these dates:

a. Evaluation of Patient G’s medical condition on or about August 31, 2012, September 10, 2012, September 12, 2012, September 13, 2012, September 2012, September 15, 2012, September 16, 2012, September 17, 2012, September 17, 2012, September 18, 2012, September 19, 2012, September 20, 2012, September 22, 2012, September 23, 2012, September 24, 2012, September 29, 2012, September 30, 2012, October 3, 2012, October 4, 2012, October 5, 2012, October 6, 2012, October 8, 2012, October 9, 2012, October 10, 2012, October 11, 2012, October 13, 2012, October 15, 2012, October 16, 2012, October 17, 2012, October 18, 2012, October 23, 2012, October 24, 2012, October 25, 2012,  October 26, 2012, October 27, 2012, November 1, 2012, November 5, 2012, November 6, 2012, November 7, 2012, November 8, 2012, November 9, 2012, November 13, 2012, and November 14, 2012.

b. Diagnosis of Patient G’s medical condition on or about August 31, 2012, September 10, 2012, September 12, 2012, September 13, 2012, September 2012, September 15, 2012, September 16, 2012, September 17, 2012, September 17, 2012, September 18, 2012, September 19, 2012, September 20, 2012, September 22, 2012, September 23, 2012, September 24, 2012, September 29, 2012, September 30, 2012, October 3, 2012, October 4, 2012, October 5, 2012, October 6, 2012, October 8, 2012, October 9, 2012, October 10, 2012, October 11, 2012, October 13, 2012, October 15, 2012, October 16, 2012, October 17, 2012, October 18, 2012, October 23, 2012, October 24, 2012, October 25, 2012,  October 26, 2012, October 27, 2012, November 1, 2012, November 5, 2012, November 6, 2012, November 7, 2012, November 8, 2012, November 9, 2012,  November 13, 2012, and November 14, 2012.

Page 125 of 202

 

c. Making recommendations for treatment of Patient G’s medical condition on or about August 31, 2012, September 10, 12,
September 13, 2012, September 2012, September 15, 2012, September 16, 2012, September 17, 2012, September 17, 2012, September 18, 2012, September 19, 2012, September 20, 2012, September 22, 2012, September 23, 2012, September 24, 2012, September 29, 2012, September 30, 2012, October 3, 2012, October 4, 2012, October 5, 2012, October 6, 2012, October 8, 2012, October 9, 2012, October 10, 2012, October 11, 2012, October 13, 2012, October 15, 2012, October 16, 2012, October 17, 2012, October 18, 2012, October 23, 2012, October 24, 2012, October 25, 2012, October 26, 2012, October 27, 2012, November 1, 2012, November 5, 2012, November 6, 2012, November 7, 2012, November 8, 2012, November 9, 2012, November 13, 2012, and November 14, 2012.

d. Making decisions regarding the treatment of Patient G’s medical condition on or about August 31, 2012, September 10, 2012, September 12, 2012, September 13, 2012, September 2012, September 15, 2012, September 16, 2012, September 17, 2012, September 17, 2012, September 18, 2012, September 19, 2012, September 20, 2012, September 22, 2012, September 23, 2012, September 24, 2012, September 29, 2012, September 30, 2012, October 3, 2012, October 4, 2012, October 5, 2012, October 6, 2012, October 8, 2012, October 9, 2012, October 10, 2012, October 11, 2012, October 13, 02012, October 15, 2012, October 16, 2012, October 17, 2012, October 18, 2012, October 23, 2012, October 24, 2012, October 25, 2012, October 26, 2012, October 27, 2012, November 1, 2012, November 5, 2012, November 6, 2012, November 7, 2012, November 8,2012, November 9, 2012, November 13, 2012, and November 14, 2012.

The catalog of charlatanry goes on like this for over 200 pages. Further charges relate to inadequate documentation, failure to assess whether patients actually had cancer, failure to inform patients about alternative treatments, failure to perform psychological assessments, a suite of charges related to abysmal FDA site reviews from early 2013, the details of charges of false advertising reported in December, innumerable unjustified medical tests and conflicts of interest, and lastly, something that we have seen many times, charges of a bait and switch, when patients were led to believe that they would be receiving Burzynski’s patented “antineoplastons” and in fact ended up on another treatment only after paying an enormous retainer for the antineoplaston treatment. The Skeptics for the Protection of Cancer Patients saw this in the case of Kathy B (deceased), who wrote on August 29, 2011:

I made this video in anticipation that I would be receiving the antineoplastons. Apparently after spending over 30,000 here I found out that the Antineoplastons are only reserved for brain cancer patients who have already undergone chemo radiation. FDA put this restriction on the Burzynski Clinic, so any other cancer patients are BASICALLY ONLY GETTING THE TRADITIOINAL ALLOPATHIC TREATMENTS OF SYNTHETIC ANTINEOPLASON PILLS THAT DID NOTHING FOR ME.

Kathy also filmed her entire visit to the Burzynski Clinic, effectively documenting the colossal deception.

Recently, the opponents of this mercenary quack were disheartened to hear that the FDA had reopened Burzynski’s farcical clinical trials. In a recent interview with USA Today, Burzynski compared his dissatisfied patients to prostitutes, extortionists, and mobstersThe Houston Chronicle reported on the lifting of the FDA ban, but not on the filing of the new charges, focusing on one family that filed a complaint:

[The FDA decision] came about a week before former patient Abra Hall, 27, of Chehalis, Wash., died following a two-year brain cancer fight. Hall’s tumor kept growing, even during the three months she tried Burzynski’s treatments. Hall died July 3.

 

Her mother, Stacey Huntington, filed a 2013 complaint with the Texas Medical Board against Burzynski, claiming the doctor was more interested in profits than helping her daughter, who routinely became ill during treatments. Huntington said her daughter repeatedly had to stop treatment and take time to recover before she could resume them. Hall never reached a maximum dose of treatment, her mother said.

 

“I just don’t understand how he can get away with what he has done,” Huntington said. “I just got duped out of $35,000. He’s greedy. He takes advantage of people who are desperate.”

 

Burzynski’s attorney, Richard Jaffe, said there was no doubt the agency would lift the [clinical hold on antineoplaston trials], calling it a good step forward. He said his client’s treatments weren’t responsible for Hall’s death.

 

“She wasn’t happy with the treatment,” Jaffe said of Huntington. “She wasn’t happy with (the costs) and she went away. (Hall) didn’t die under the clinic’s watch. There’s bad blood there. There have been a couple of patients like that.”

Abra was cremated last week. Burzynski will show up to work in the morning like he has every day for the last 40 years.

As a postscript, when this news broke over the weekend at the Amazing Meeting 2014, a conference devoted to science advocacy in the public interest, a thousand people cheered the release of this document, which could cost this despicable creature the right to treat patients ever again:

While we hope that the TMB can end this abomination, Burzynski has gotten away with too much for too long for skeptics to sit by while the case develops. We are urging Texans to bring these charges to the attention of Governor Perry’s office, and make it clear that this is a prosecution that is long, long overdue. If you want to help keep the pressure on this quack, please join the Skeptics for the Protection of Cancer Patients and like their facebook page. For the full range of horrors that skeptics have uncovered, see the case of Briannah O. For a complete summary of the Burzynski saga, see David Gorski’s recent cover article about Burzynski from Skeptical Inquirer, and the accompanying article that brings the fight up to the present.

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Time to Act!

Exciting news. The Center for Inquiry has picked up the Burzynski issue and is devoting resources to our fight against Burzynski’s inane and exploitative medical adventurism. Today, they sent a letter to the officials at the FDA who were apparently responsible for the recent decision to allow Burzynski to reopen his endless, unrevealing, but highly lucrative clinical trials. They also sent the letter to USA Today.

Please write to your congressional representative about Burzynski, and feel free to read through and adapt the CFI letter for the text of your communication with your rep. Report any replies you receive to skepticsprotect@gmail.com.

Also, we are STRONGLY encouraging skeptics to contact Sen. Claire McCaskill’s office. Sen McCaskill was the one who brought Dr. Oz in front of her committee last week. You can use her consumer protection alert page to encourage the office to take this issue seriously. St. Louis skeptics had a meeting with her staffers last week, so they know what our complaint is. We would like you to just let them know that you are excited about their involvement and that it really is a worthy use of the Senator and her staff’s time.

 

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A Call to Action: Sign Our Petition to Fight Cancer Quack Burzynski

Sign our Change.org petition!

OVER 100 OVERDOSES AND ALL BASELINE SCANS “DESTROYED”

In November, the FDA released inspection notes from a visit to the Burzynski Clinic that took place at the beginning of last year. The owner, Stanislaw Burzynski, has claimed for over 35 years to have a proprietary treatment that treats the most deadly brain cancers (as well as AIDS and a whole host of other unrelated diseases). He has been distributing these drugs under the auspices of “clinical trials” for over 15 years. Of the over 60 trials that Burzynski opened he has completed and published exactly zero.

The latest FDA observations are damning in the extreme. For instance:

  • Burzynski (as investigator, the subject of the inspection) “failed to comply with protocol requirements related to the primary outcome, therapeutic response [...] for 67% of study subjects reviewed during the inspection.” This means that several patients who were reported as “complete responses” did not meet the criteria defined in the investigational plan, as were patients who were reported as having a “partial response” and “stable disease.” This means that his outcomes figures for these studies are inaccurate.
  • Additionally, some patients admitted failed to meet the inclusion criteria for the study.
  • Even though patients needed to have a physician back home to monitor their progress prior to enrolling in a trial, the FDA found a patient who began receiving treatment before a doctor had been found.
  • Patients who had Grade 3 or 4 toxic effects were supposed to be removed from treatment. One patient had 3 Grade 3 events followed by 3 Grade 4 events. Another patient had 7 disqualifying toxic events before he was removed from the study.
  • Burzynski did not report all adverse events as required by his study protocols. One patient had 12 events of hypernatremia (high sodium), none of which was reported. There are several similar patients.
  • The FDA told Burzynski: “You failed to protect the rights, safety, and welfare of subjects under your care. Forty-eight (48) subjects experienced 102 investigational overdoses between January 1, 2005 and February 22, 2013, according to the [trial number redacted] List of Hospitalizations/SAE (serious adverse events) [redacted]/ Overdose [redacted]/Catheter Infection report. Overdose incidents have been reported to you [....] There is no documentation to show that you have implemented corrective actions during this time period to ensure the safety and welfare of subjects.” [emphasis added] It seems that these overdoses are related to the protocol, which requires family members to administer the drugs via programmable pump on their own. Further, patient records show that there were many more overdoses that were not included in the Hospitalization/SAE/Overdose list.
  • “Your [...] tumor measurements initially recorded on worksheets at baseline and on-study treatment [...] studies for all study subjects were destroyed and are not available for FDA inspectional review.” This is one of the most damning statements, as without any…not a single baseline measurement…there is no way to determine any actual effect of the antineoplaston treatment. This means that Burzynski’s studies–which by last account cost $30,000 to begin and $7000 a month to maintain–are unpublishable.
  • Some adverse events were not reported to the Burzynski Clinic IRB for years. (One patient had an adverse event in 1998 and the oversight board did not hear about it until 2005.)

Since the release of this information, the Burzynski Clinic has been the subject of a USA Today feature which chronicled his abysmal research track record and failure to produce meaningful results. Now that Burzynski is facing sanctions with the FDA and the Texas Medical Board, it is time that skeptics acted to make sure that this Teflon quack does not get off again. Please sign our new petition. The Skeptics for the Protection of Cancer Patients will see to it that your signature makes gets in the hands of lawmakers.

Sign our Change.org petition!

 

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Lobbying Congress for Action

*Congressional feedback submission form is at the bottom of this page* 

Now that Burzynski’s failure to help patients has been thoroughly documented by USA Today, it is important that skeptics and patient advocates seize the opportunity to press Capitol Hill to take action and investigate how it was that a quack like Burzynski was able to charge patients, their families, and their communities for an unproven and supremely unpromising therapy for decades.

To do this, you must write your representatives in the House and Senate and ask them to launch an investigation. We don’t mean “send them an email.” We need you to send in an actual physical letter to their office and follow it up with a phone call or a visit to their local office. Usually their contact info is on their office website. You may want to send your letters to your reps’ DISTRICT offices, as there may be delays of several weeks sending letters to Capitol Hill due to security screenings. Alternately you may fax them.

We are providing a couple of documents for your convenience, and we hope you use them. First, we have a draft letter to your congressperson you can use, but you should tailor it to your representative. Go to their website and find out which committees that they are on. If they are on a science, research, or oversight committee, you want to make the case that their committee has a stake in the outcome. Also, check their Wikipedia biography to see if they are a cancer survivor. This is crucial, as we will follow up on promising leads. Also, when you report in, note which staffer in the representative’s office you’ve been referred to and any details about them that you think might help us craft persuasive communications (for instance, a family member with cancer, if they mention it). You can send all that info to skepticsprotect [at] gmail [dot] com.

Besides your modified, personalized letter, we ask you to send along a physical copy the 483s, the FDA’s documentation of all the Clinic’s research protocol and ethics violations for the last decade. Lastly we ask you to include the most recent warning letters that were sent to Burzynski and to his Institutional Research Board. We want those documents and the horrors they contain in the hands of our representatives. And we want them to act.

In your letter, ask for an investigation and remember to set aside time on your calendar in two weeks to call your representative and follow up. Ask specifically if they will support an investigation of how the FDA allowed Burzynski’s research to go unimpeded for decades despite ample warnings and horrific site reviews.

Please check the Childhood Cancer Caucus to see if your representative is a member. Burzynski has claimed that his antineoplastons can cure even the most devastating and difficult childhood brain tumors, including brain stem tumors. His track record of experimentation on children–and his lack of results to show for it–should be investigated, and these congresspersons will be crucial.

The key committee regarding this matter in the House is the Committee on Oversight and Government Reform, and we certainly recommend that you look and see if your representative is on that committee. But you can also approach the committee itself (or the Subcommittee on Energy, Health Care and Entitlements) for an investigation into the FDA’s continued approval of Burzynski’s catastrophically flawed trials. Send your documents here:

Committee on Oversight and Government Reform
2157 Rayburn House Office Building,
Washington, DC 20515
Phone: (202) 225-5074 Fax: (202) 225-3974

In the Senate, your best bet is the Committee on Health, Education, Labor and Pensions. If your senator (listed below) is on one of these committees, please take special action and write to them.

Committee on Health, Education, Labor and Pensions
428 Senate Dirksen Office Building
Washington, DC 20510

Democrats by Rank

Tom Harkin (IA)
Barbara A. Mikulski (MD)
Patty Murray (WA)
Bernard Sanders (I) (VT)
Robert P. Casey, Jr. (PA)
Kay R. Hagan (NC)
Al Franken (MN)
Michael F. Bennet (CO)
Sheldon Whitehouse (RI)
Tammy Baldwin (WI)
Christopher S. Murphy (CT)
Elizabeth Warren (MA)

Republicans by Rank

Lamar Alexander (TN)
Michael B. Enzi (WY)
Richard Burr (NC)
Johnny Isakson (GA)
Rand Paul (KY)
Orrin G. Hatch (UT)
Pat Roberts (KS)
Lisa Murkowski (AK)
Mark Kirk (IL)
Tim Scott (SC)

During the upcoming winter recess, you might want to stop by your representatives’ district offices. From experience, I know that these offices are congenial places and the staff is genuinely interested in hearing from constituents. It would be positively outstanding of you to sit down with a staff member and walk them through the FDA documents.

When you have contacted your reps, fill out this form to report on your interaction with your representative so we can follow up in the best way possible. One submission per congressional office contacted, please. Send questions and supporting documents to rjblaskiewicz [@T] gmail [d0t] com.

(*UPDATE* We are getting reports that people who are submitting their letters via the web are generally not able to attach the documents and are being shrugged aside. This is why we are asking you to send the documents via snail mail.)  

To skeptics outside of the US who want to help, you can write about Burzynski. We have a page that shows how to boost good information into the searches that Burzynski ranks well in. Please use those same strategies to link to the USA Today article. Another possibility is for skeptics with expertise in languages other than English to contact Susan Gerbic’s Guerrilla Skepticism on Wikipedia to see if they need anyone to translate the Burzynski page into those languages–Burzynski appeals to desperate people all over the world. If you know someone who could translate his page into Chinese, for instance, that would be wonderful.

Any questions can be can be directed to skepticsprotect [at] gmail [dot] com. You can leave tips in the comments of this page.

Thank you in advance for all you are going to do.

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Action Needed! Burzynski Infomercial to Appear on Colorado Public Television

On March 7th, PBS station CBT12 in Colorado is going to air the hagiographic Burzynski: Cancer is Big Business. CBT12 is notorious for using conspiracy theories to raise money at pledge time. It’s a cheap tactic. Last year, they aired the AE911 Truth movie during pledge week. It’s lucrative. Most conspiracy theorists, while they openly distrust mainstream media outlets, seem to yearn for the respectability that comes from being broadcast on them. And when their stories appear on CPT12, and I say this because the station continues to push this garbage, it seems that the conspiracy theorists reward the station.

I have come to expect the exploitation of ignorance on the part of CPT12. When it’s a truther movie, well, it makes PBS look bad, but that’s about it. But this movie has led so many people into Burzynski’s clutches, gotten so many patients entangled in his unpublishable trials and quack “gene therapy”, that I can say with a high degree of confidence that CPT12 is BANKING ON ITS VIEWERS’ LIVES.

Worse, at the breaks in the film, Eric Merola, the guy who contacted my employer in December, will be appearing alongside a spokesperson for the clinic to talk to the station’s fundraising director. This is unacceptable. Nonetheless, CPT12 has taken down misleading alt med propaganda before, so it is worth taking a strong stand and lobbying that they follow precedent and take this down.

Most importantly, one should contact Colorado state legislators who are also cancer survivors and alert them to this upcoming travesty, including state senator and esophageal cancer survivor Rollie Heath (rollie.heath.senate@state.co.us(303) 866-4872, fax: (303) 866-4543) and state representative and breast cancer survivor Dianne Primavera (dianne.primavera.house@state.co.us(303)-866-4667).

You might also contact the station, and demand that they either change their schedule or have an independent physician appear with Burzynski’s toadies. You know, because it’s a medical issue and a movie director and PR guy can’t add anything meaningful to the discussion.

Shari Bernson (she’s the host between breaks)
Director of Development
sbernson@cpt12.org

Willard “Wick” D. Rowland, Jr
President & CEO
wrowland@cpt12.org

Station:  (303) 296-1212
Toll-Free:  1-800-727-8812
Fax:  (303) 296-6650

Also, please register a complaint with the PBS ombudsman about the movie being aired at all and this weird little station’s repeated tarnishing of the name of public broadcasting:

http://www.pbs.org/ombudsman/feedback.html

We are making only reasonable, responsible requests. PLEASE follow through and contact the station and the PBS ombudsman.

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PRESS RELEASE

BURZYNSKI CRITICS HAND CONTROVERSIAL DOCTOR A “BIRTHDAY PRESENT”

Skeptical group says the 70-year old peddles unproven cancer treatments to desperate patients

For immediate release:
January 23rd, 2013

Challenge Delivered on Wed, 23 Jan 2013

Challenge Delivered on Wed, 23 Jan 2013

HOUSTON —This morning, a group calling itself Skeptics for the Protection of Cancer Patients (SPCP) has delivered controversial cancer doctor Stanislaw Burzynski a birthday present: a $13,000 donation in his honor to St. Jude Children’s Research hospital. The SPCP says that St. Jude’s is a well-respected, compassionate institution that does real research into childhood cancers, unlike the Burzynski Clinic, which has never produced the results of a single large scale peer-reviewed clinical trial in a reputable journal in over 30 years, despite apparently having treated thousands of patients with so-called “antineoplastons”.

The group claims that the Burzynski Clinic has charged the most desperate cancer patients hundreds of thousands of dollars to participate in trials of his unproven therapy – trials that have not only ignored the ethical prohibition against charging patients to participate in trials, but have also failed to publish meaningful results demonstrating the effectiveness of the treatment. Hundreds of patients, driven to desperation by their disease, have resorted to begging in the press for money to receive the treatments only to die penniless.

In their letter, the SPCP challenges Dr. Burzynski to counter some of the harm done in his name and  “acknowledge the generosity of cancer survivors, their families and their communities around the globe by matching the total amount contributed to St. Jude, thereby doubling the total gift toward childhood cancer research.” The letter also tells of a former pancreatic cancer patient who created a website (http://burzynskiscam.com/) to document his experiences at the hands of the Burzynski Clinic, only to receive legal threats and intimidation from a clinic supporter – threats that the clinic and Dr. Burzynski have yet to adequately address.

“Dr. Burzynski’s patients are literally dying for a cure. As they undergo his endless and apparently unpublishable medical ‘trials,’ they lose precious time and often empty their bank accounts, leaving their families in grief and debt,” said SPCP founder Robert Blaskiewicz. “The most compassionate thing Burzynski could do would be to close his doors for good, but we’re asking for the next best thing: to open his pocketbook and fund legitimate cancer research for once.”

The birthday card and accompanying letter were delivered to the Clinic on Wednesday, Stanislaw Burzynski’s 70th birthday. The letter is available, in full, on request.

###

The Skeptics for the Protection of Cancer Patients is a group of cancer survivors, family and community members, devoted to advancing ethical, promising, and transparent cancer research. For more information, visit thehoustoncancerquack.com or the SPCP Facebook page.

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Happy Birthday, Dr. Burzynski!

birthday-quack

In honor of Dr. Stanislaw Burzynski’s 70th birthday on January 23rd, 2013, the Skeptics for the Protection of Cancer Patients are fundraising for St. Jude Children’s Hospital. Our goal is to raise at least $30,000 by Burzynski’s birthday, the approximate cost of entering one of his clinical trials of antineoplaston therapy. On his birthday, we will deliver a present to the Clinic, a challenge to Dr. Burzynski to match the total sum donated by skeptics, science advocates, and others who value good research into devastating forms of childhood cancer. The more you give, the more we ask of Burzynski.

Please visit http://www.crowdrise.com/fightchildhoodcancer/ and donate to St. Jude, a fantastic organization that does not turn away patients who cannot pay. 

Check out what the Amazing Randi has to say about his experiences with cancer treatment:

What else can you do to help?

WRITE ABOUT BURZYNSKI!!! Here are some awesome ways, including Google strategies, to get reliable information about antineoplastons and ethical clinical trials into the hands of potential Burzynski patients.

LEARN ABOUT BURZYNSKI!!!

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