Breaking News
We MUST help little Thomas Navarro!
The FDA is still denying Thomas the treatment his parents want him to have. And, unbelievably, NO ONE in the US government is more powerful than the FDA.
To Help Thomas, Click Here: www.citizens.org.
For the Story on the Press Conference and Photos, Click Here: www.naturalhealthline.com.
Update: April 2000
Please, take 5 minutes of your valuable time to find out how you can call and write your US senators and representative, Reps. Thomas Bliley, Jr. (especially Rep. Bliley whose hands this bill lies in right now), and Michael Bilirakis. Tell tell them they must support the "Thomas Navarro FDA Patient Rights Act," Bill HR 3677. Congressman Dan Burton, Chairman of the House Oversight Committee on Government Reform is the author of the bill. He introduced it in a press conference on February 16, 2000. For more on this bill and many more stories on Thomas, see Thomas's website.
YOU Really CAN Make a difference
in a little boy's life!
It seems the US government and the press care more about a Cuban boy, who is healthy and has two homes, than about an American boy, who is dying and has been away from his home for over 3 months because the FDA refuses to just say "Yes."
Four-year-old Thomas Navarro, his little brother, Patrick, and their parents have been in a hotel room in Houston, Texas, since before Thanksgiving, for months now, waiting for the FDA to just say "Yes." This cannot be permitted to go on. The Navarros should be allowed to choose a nontoxic, FDA-approved, clinical trial over toxic chemotherapy and radiation for their little boy. Thomas must be given antineoplastons and allowed to go HOME before it is too late for him.
THOMAS NAVARRO NEEDS YOUR HELP TO GET THE TREATMENT HIS PARENTS WANT FOR HIM
Little Thomas Navarro of Tucson, Arizona, and his family are in the midst of battling for his life. Thomas has medulloblastoma and had surgery in September to remove the tumor. However, this type of cancer always recurs. So, Thomas' parents chose to take him to Dr. Burzynski, instead of subjecting their little boy to combination chemotherapy and radiation and their life-threatening and long-term side effects. These toxic treatments offer no cure. Also, because he has no tumor, Thomas is ineligible to be treated in one of Dr. Burzynski's clinical trials. The Navarros want their son treated under Special Exception status. [Obtaining a Special Exception is another problem the Navarros face.]
See below for how you can help join the protest against what is being done to this little boy. Thomas needs your help to battle his cancer. The Navarros need your help to fight their way to the Burzynski Clinic, to obtain the freedom of choice every American deserves, and to choose quality of life for their son.
See Thomas' website for the whole story.
Dear Members of the Burzynski Patient Group,
In the past, our patient group has asked for your help, and you have always come through. We truly appreciate it. I know everyone is busy because of the holidays but as we make plans with family and friends, little Thomas Navarro and his family are waiting in a hotel room in Houston, Texas, since before Thanksgiving! They are waiting for the FDA to allow Thomas to participate in a clinical trial that may save his life. We need you to write to the president, vice president, congressmen, and senators, as listed at the end of this letter.
Four-year-old Thomas Navarro of Tucson, Arizona, has a medulloblastoma brain tumor, which also is called a PNET tumor. This is the same kind of tumor that Dustin Kunnari was diagnosed with at the age of 2 ½ years. As you may know, Dustin is in remission and off treatment with antineoplastons. He is a healthy 8-year-old. Unfortunately, if the FDA gets its way, Thomas will not be as lucky as Dustin. Thomas will have to undergo chemotherapy and radiation therapy, and may end up dying or living with severe physical and mental deficits.
After Thomas had the tumor removed surgically, his parents, Jim and Donna, decided their son’s best chance for survival was Dr. Burzynski’s antineoplaston therapy. However, Thomas’s doctors in Tucson did not agree. Currently, if the Navarros return to Arizona, Thomas will be taken away from them. It seems his doctors feel it is better for Thomas to be taken from his family and subjected to chemotherapy and radiation therapy, rather than have the treatment his parents have chosen. This is true even though these doctors know that the treatments they are recommending are experimental, because these therapies have never been approved by the FDA for use in young children. However, unlike antineoplastons, these therapies are extremely toxic.
Because the brain tumor is not measurable and because Thomas has not had chemotherapy and radiation therapy, he cannot be enrolled in Dr. Burzynski’s Protocol BT-12 for medulloblastoma. Furthermore, the FDA refuses to give Thomas the status of being a "Special Exception." Over the past 3 months, Jim and Donna have fought the FDA for their son’s life. They just want Thomas to be treated with antineoplastons. Dr. Burzynski has complied with all of the FDA’s requests, to no avail. (Everyone agrees the requests are just stalling tactics.) Senator John McCain, a presidential candidate, has been in daily contact with the FDA on Thomas’s behalf. Still, the FDA feels it can continue to deny the Navarro’s request.
We don’t know what it will take to get the FDA to change its angry mind. This agency continues to wreak its vengeance on innocent children in attempts to get to Dr. Burzynski. This must stop. Even though Dr. Burzynski’s results with medulloblastoma are very good--and far better than anything traditional medicine has to offer--the FDA has the power to say "No." The FDA can come up with excuses endlessly. But we can do something about it, and we must do it NOW.
A US Congressman once told our patient group that individual members of congress do not have much power, but if we can get lots of people to write and call them regarding a certain issue, then they are forced to take some kind of action.
Please keep in mind that children are alive today because of your help. All of you have allowed the Burzynski Clinic to remain open and have succeeding in the incredible effort to have Dr. Burzynski vindicated in court. Because of you and your efforts, he is now conducting 72 clinical trials for cancer, one for HIV, and one for autoimmune diseases. His results are very exciting, and he plans to apply for approval for antineoplastons in the near future, hopefully in the year 2000. We are trying to make the year 2000 Dr. Burzynski’s year, and Thomas Navarro’s year!
But Thomas is not an isolated case. There have been many children in the same situation. Some of these parents have been forced under court order to subject their children to chemotherapy and radiation therapy, even though they knew in their hearts it was WRONG. You can make a real difference in a child’s life. Don’t let the FDA allow Thomas to die! Thomas has no time to lose.
Please write a short letter to the President and send copies to the Vice President and all of the congressmen and senators listed on the last page. I’ve provided you with their addresses; all you have to do is cut them out and paste them on an envelope. Here are some suggestions on what to write, if you feel awkward using your own words:
Even experts admit that conventional treatments for medulloblastoma usually cause severe and permanent mental and physical harm, other types of cancer, and even death.
Chemotherapy and radiation therapy are experimental because they have never been approved by the FDA for use in young children.
Why cannot Thomas have an experimental treatment that causes no harm at all and that has proven to be effective in a number of children, instead of therapies that surely will harm him permanently?
Thomas’s parents must have the freedom to choose the medical treatment they want for their son. It is they and their son who will have to live with the consequences of that treatment.
Doctors complain there are not enough patients enrolling in clinical trials. Here we have parents literally begging and for months to have their son enrolled in an FDA-approved clinical trial.
Thomas’s case is one reason it is so important for Congress to pass the Access to Medical Treatment Act. This act currently is languishing in Congress because of the special interest groups that oppose it. (After all, why should citizens of the Land of the Free have freedom to chose what they want over doctors who know what is best for everyone?) This act would allow doctors to treat patients with any non-FDA-approved therapy as long as the patient is informed the treatment is not approved and of its side effects.
Please give this letter to everyone you know. Ask them to write to save Thomas’s life. You really can make a difference in this child’s life and, just maybe, Thomas can go home for Christmas.
We have beaten the FDA before. We need to do it again--and again, and for as long as it takes.
Have a happy and healthy Year 2000, be thankful that your family is not in the Navarros’ position, and pat yourself on the back for doing a wonderful thing!
Rita Starr, Burzynski Patient Group
FAX: 305-535-2509
E-MAIL: pwalter@nni.com
__________________________________________________________________________________________________________
In addition to writing to congress, please phone, fax, or e-mail the following people:
Richard Pazdur, FDA
Phone: 301-594-2473 Fax: 301-594-0493
Jane E. Henney, FDA Commissioner
Phone: 301-827-2410 E-Mail jhenney@oc.fda.gov
Donna Shalala, Secretary of the US Department of Health and Human Services
Fax: 202-690-7595
The members of congress listed below have helped in the past. They know the Burzynski story and are more likely to help than are other members of congress.
PLEASE WRITE, CALL, FAX, OR E-MAIL ALL OF THE FOLLOWING (If you can't contact all of them, contact a few in the order listed. The most effective way is writing a letter; you can write to just one person and copy the rest, but put a sticky on the copy stating it is an urgent matter. Also, you can fax the letter. Calling is also very effective. E-mailing is the least effective because of the huge amount of e-mail the congressmen and senators receive. But rather than do nothing at all, please e-mail.):
1. The Honorable John McCain
241 Senate Russell Building
Washington, DC 20510
Phone: 202-224-2235
Fax: 202-228-2862
2. The Honorable Dan Burton
2185 Rayburn House Office Building
Washington, DC 20515
Phone: 202-225-2276
Fax: 202-225-0016
3. The Honorable Thomas Harkin
731 Senate Hart Building
Washington, DC 20510
Phone: 202-224-3254
Fax: 202-224-9369
4. The Honorable Joe Barton
2264 Rayburn House Office Building
Washington, DC 20515
Phone: 202-225-2002
Fax: 202-225-3052
5. The Honorable Arlen Specter
711 Senate Hart Building
Washington, DC 20510
Phone: 202-224-4254
Fax: 202-228-1229
6. The Honorable Richard Burr
1513 Longworth House Building
Washington, DC 20515
Phone: 202-225-2071
Fax: 202-225-2995
richard.burrNC05@mail.house.gov
7. The Honorable Peter DeFazio
2134 Rayburn House Office Building
Washington, DC 20515
Phone: 202-225-6416
Fax: 202-226-3502
8. President Bill Clinton
The White House
1600 Pennsylvania Avenue, NW
Washington, DC 20500
Phone: 202-456-1414
9. Vice President Al Gore
The White House
1600 Pennsylvania Avenue, NW
Washington, DC 20500
Phone: 202-456-2326
Fax: 202-456-7044
An Effective Cancer Therapy that Challenges Convention
is what Dr. Julian Whitaker is saying about Dr. Burzynski's antineoplaston therapy. Dr. Whitker long has been a supporter of Dr. Burzynski.
Julian Whitaker, MD, has practiced medicine for over 25 years, after receiving degrees from Dartmouth College and Emory University.
See the October 1999 issue (Vol. 9, No. 10) of Dr. Julian Whitaker's newsletter, Health & Healing. Tomorrow's Medicine Today for the complete article.
Subscription price is $69/year. Contact customer service at 1-800-539-8219 for subscription information, or check out Dr. Whitaker's website at www.drwhitaker.com.
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Cancer Class Action Suit
Dr. Lew Brenneman, MD, PhD, is an immunologist who has treated chronic diseases including cancer and autoimmune disease for 20 years. He has done research with Linus Pauling at Stanford University and has testified as an expert witness in numerous lawsuits. Over the years, he became distressed by the devastation of chemotherapy and radiation therapy on his patients. Dr. Brenneman believes that a class action suit against the pharmaceutical industry will force change. (Taken from Dr. Brenneman's website.)
If you are interested, see his website: www.cancerclassactionsuit.com
The Burzynski Patient Group received this information from a concerned member; we have not investigated this information and have no experience with Dr. Brenneman. If you choose to contact him, please give us your opinion: pwalter@nni.com.
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A R C H I V E
Insurer is Sued Over Ads for HMO
Aetna US Healthcare says it cares for clients' health. A California group says the company cares for profit.
Summary of a Philadelphia Inquirer article, April 20, 1999, written by Karl Stark
On April 19, 1999, a California consumer group filed suit against Aetna US Healthcare. The Foundation for Taxpayer and Consumer Rights is a nonprofit advocacy group in Santa Monica, California. It alleges the giant HMO systematically misleads patients by stating in ads that members' health is its first priority. It is alleged in the suit that Aetna's real goal is to generate shareholder returns. The suit also alleges that Aetna uses financial incentives to reward doctors who give less care.
"In crucial areas, what Aetna's all about is making money," said Ed Howard, senior counsel for the consumer group. "Aetna has embarked upon a campaign to eliminate the ability of doctors to have any kind of meaningful say in how medical care is provided."
The group says its suit against Aetna is the first federal racketeering suit to be filed against an HMO since the US Supreme Court ruled that consumers could sue insurers under the RICO (Racketeer Influenced and Corrupt Organizations) Act. The ruling came down in January of this year. If successful, a suit won under the RICO Act could bring triple the amount of damages.
The consumer group's suit closely follows similar charges made by the American Medical Association against Aetna in the past 2 years.
Basically, the suit alleges false advertising. Many of Aetna's advertisements are quoted in which it states that its main goal is improving and maintaining the health of its members. The suit says that Aetna is more interested in cutting medical costs. It is charged that doctors who sign contracts with Aetna are paid more if they have over750 patients; that doctors receive incentives when patients do not use emergency rooms and hospitals; and that secret contracts between Aetna and its doctors hurt patient care.
Also, because HMOs cannot be sued by members of plans regulated under the federal Employee Retirement Income Security Act, ERISA, Aetna encourages its doctors to give more treatment to members of non-ERISA plans.
Aetna spokeswoman Jill Griffiths declined comment on the suit because company officials had not yet seen it.
- - - International Conference on Integrative Medicine (ICIM) - - - Seattle, Washington, April 30 to May 2, 1999
The International Conference for Integrative Medicine will be held at the Washington State Convention Center from April 30 through May 2. The Health Broadcast Network (HBN) will cybercast this event live: www.HealthBroadcastNetwork.com. About 30,000 people are expected to attend the associated Health Expo. The Burzynski Patient Group will have an information booth at the Expo.
About 50 media groups, including PBS, will be covering the event. On the Internet, the major search engines, such as Yahoo, will be advertising for HBN. A large, worldwide viewing audience is expected.
Dr. Burzynski will speak Saturday afternoon, May 1, about his phase II clinical trials of antineoplastons in brain stem gliomas.
In a separate Breakout Session Saturday morning, May 1, members of the Burzynski Patient Group will speak.
Dr. Stanislaw R. Burzynski will speak on his phase II trials of antineoplastons in brain stem gliomas. Dr. Burzynski is one of the most prominent unconventional pharmacological practitioners of our time. He is completely committed to the open scientific evaluation of his therapy. Over the past 20 years, Dr. Burzynski has treated over 4000 patients with antineoplastons. He has authored over 150 scientific papers and has 52 patents on antineoplastons. Antineoplastons are proving to be effective in the treatment of brain tumors and other types of refractory cancers.
The International Conference on Integrative Medicine (ICIM) is intended to be a working forum focusing on the challenges and opportunities of integrated care. To answer the many questions integrative medicine poses, Bruce Takata, Project Director, says that "We have done our best to present speakers and create an agenda that is substantive in content, comprehensive in scope, and diverse in orientation."
The mission statement of the ICIM is "to provide an informative, stimulating, and compelling series of sessions to encourage and inspire an ongoing dialogue among individuals and groups committed to the positive evolution of health, healing, and well-being."
Studies have indicated that the public's use of and expenditures on alternative medicine have increased dramatically over the past 10 years. The goal of the ICIM is to enhance participants' understanding and application of concepts and issues related to the integration of complementary and alternative medical therapies into conventional medical treatment. Topics include treatment strategies, access issues, scope of practice, research findings and challenges, and philosophical issues in medicine.
University of California at San Francisco Charged with Misleading Parents of Young Cancer Patient
TRIAL UPDATE (as of April 1999): The trial has been postponed until August 15, 1999
The courthouse is San Francisco County Superior Court, 400 McAllister Street, San Francisco, California.
On March 15, 1999, in San Francisco, an important case goes to trial. It is about patients' rights and doctors' responsibilities. The parents of a 6-year-old identical twin with a brain tumor are suing the University of California at San Francisco (UCSF) Medical Center. Ric Schiff, a San Francisco police sergeant, and his wife Paula claim that UCSF over-radiated their little girl. Moreover, doctors steered the Schiffs away from an experimental cancer therapy, which these doctors knew to be effective. The court will consider the potential conflict of interest, medical ethics, and issues of informed consent as they affected one little girl's life.
The tragic story began 6 years ago when 4-year-old Cryssie Schiff was diagnosed with a malignant brain tumor. Doctors told the Schiffs there was no cure. After an initial surgery, they were given only two options: do nothing and watch their daughter die, or agree to massive chemotherapy and radiation treatments. However, the doctors did not disclose the potential devastating side effects.
Desperate, the Schiffs asked UCSF doctors if there was any other treatment that could help Cryssie. They were told "No." The Schiffs reluctantly agreed to the recommended treatment.
At issue is whether UCSF doctors told the Schiffs the whole truth. After Cryssie endured conventional therapy, her cancer remained. The Schiffs continued their research and found a promising experimental therapy that they would later learn UCSF did indeed know about. Cryssie's parents started her on antineoplastons, naturally occurring substances believed to control cancer. Cryssie soon was in remission, and with antineoplaston treatment she did will for the next one and a half years.
Unfortunately, this story has no happy ending. Even though the Schiffs found a treatment to control their daughter's brain cancer, the irreversible damages of massive radiation and high-dose chemotherapy led to her death. An autopsy showed Cryssie died free of cancer.
The Schiffs' grief turned to outrage when they learned that UCSF had previously treated two patients with brain tumors who were cured on antineoplastons, the same therapy the Schiffs had found on their own that had worked for Cryssie. To add insult to injury, the Schiffs also learned that UCSF had begun to research and conduct clinical trials on a compound remarkably similar to antineoplastons. The substance, phenylacetate, is a component of antineoplastons. A former government researcher had learned about phenylacetate while working with Dr. Burzynski.
Dr. Burzynski's antineoplaston therapy has been the subject of many news reports and a recently published book, The Burzynski Breakthrough, by Tom Elias. In early 1997, Dr. Burzynski was acquitted of numerous federal charges brought against him by the FDA in a high-profile court case in Houston, Texas.
The trial in Houston did not allow a discussion of the effectiveness of antineoplastons but, instead, focused on matters of interstate commerce. The upcoming Bay Area trial promises to center on whether this treatment works for some types of brain cancers.
Witnesses at this trial will include Dr. Burzynski, noted radiation therapists, oncologists, and former patients cured by antineoplastons. Dr. Julian Whitaker, a well-known health advocate, also will testify.
Dr. Burzynski has now completed a number of FDA-approved clinical trials for the treatment of brain cancer and is expected to apply for federal drug approval soon.
Since Cryssies's death, the Schiffs have spoken about their ordeal before Congress on several occasions and testified for the rights of cancer patients.
See David Doherty's story for more about UCSF.
An Open Response to the National Council Against Health Fraud
Their newsletter contains the following article
A Burzynski Research Institute (BRI) company press release announced on May 24 that its Antineoplastons A10 and AS2-1, when used in combination, produced either complete tumor elimination or greater than 50% reduction in tumor size in 43 of 178 patients (24.1%). An additional 72 patients (40.5%) experienced stable disease, meaning that their tumors did not progress or shrink more than 50%. The two largest groups of patients suffered either from glioblastoma multiforme (36.5%) or astrocytoma-type tumors (32%). These results are exciting, the report said, because conventional treatments are generally considered ineffective against such tumors. BRI now believes it has enough data to apply for FDA approval.
Comment. The study was forced on BRI by the government as part of an action taken more than 2 years ago. It will be interesting to see how other researchers respond to the BRI data. Information on brain tumors from the National Cancer Institute does not agree with the BRI statement that conventional therapy is ineffective.* It can also be asked if the nature of the BRI produces any kind of a selection effect of the type of patients that are enrolled. For instance, does the travel and effort involved eliminate sicker patients in favor of those who may be surviving longer due to the nature of their diseases? There is also the matter of replication by another cancer research facility that doesn’t have the emotional or financial self-interest of BRI. At this point, we can only hope that an effective treatment for brain tumors has been found. If it has, it will be a shame that it took action by the government, and so much time to get the testing done.
*PDQ State-of-the-Art Cancer Treatment Summary for Health Professionals: Childhood cerebral astrocytoma, 7/97.
RESPONSE
Now, if I may, I’d like to point out the untrue (perhaps fraudulent) statements in the newsletter comment:
This is not true. The study was, in fact, "forced" upon the government (FDA) by patient lobbying and congressional investigation. What the government (FDA) tried to do was close Dr. Burzynski down by taking him to federal criminal court for "crimes" he did not commit. The patients had to lobby Congress to keep the Clinic open. After a congressional investigation, the FDA agreed to allow the patients to continue receiving antineoplastons under an existing Investigational New Drug Permit (IND 43,742). Burzynski submitted 69 protocols (for various cancers), and the FDA reluctantly approved them. It was only the pressure from the patients that kept the Clinic open at that time. Burzynski was completely cleared in federal court of the ridiculous crimes of which they accused him.
I can point to many researchers and oncologists, all of whom agree that the current treatments for GBM’s and astrocytomas are ineffective. The NCI doesn’t use the same definition for "effective" that the general population uses. Shrinking a tumor for 2 months is hardly a sign of an effective treatment if the patient dies 2 months later from the tumor or side effects of the treatment.
This statement shows only the ignorance of the person writing the comment. First, the Karnofsky score (an indicator of the health of a patient) is a criteria used to approve entry to virtually all clinical trials on BTs. Patients with scores that are too low are generally not allowed into clinical trials. To quote from the protocol of the FDA-approved Phase II Study of Antineoplastons A10 and AS2-1 in Children with Low Grade Astrocytoma: "Patients must have a performance status of 60% to 100% on the Karnofsky Performance Scale" in order to be admitted into the study. This is an FDA requirement.
Second, no institution treating brain tumors could claim the same success on any similar sized group of brain tumor patients, regardless of the selection criteria they used. Whether Burzynski is using inappropriate selection criteria is irrelevant next to the fact that he is getting dramatic responses with a treatment that has none of the conventional side effects.
This is a matter alright. However, with the BRI data and the weaker data on independent phenylacetate trials, let’s approve it for use now with brain tumors and get it out there so the results can be replicated. An independent trial should also be run comparing Burzynski’s antineoplaston treatment with phenylacetate alone. Currently, some form of Dr. Burzynski's treatment should be offered to every astrocytoma patient as a first-line treatment.
Burzynski’s treatment is more effective and less harmful than anything currently approved. Please get the facts straight on this issue. The NCI reviewed the success of this treatment in 1990 and found it to be effective. The NCI started clinical trials then canceled them after receiving a large grant from Elan Pharmaceutical to conduct phenylacetate trials instead (one component of antineoplastons). Phenylacetate alone is not as effective. Now the government is facing a review of Burzynski’s trials (which were forced upon them) and they have egg all over their face for delaying the progress on this effective treatment while, for some reason, pursuing phenylacetate instead.
Don’t imply that Burzynski has been holding up this treatment when he has had to spend incredible resources fending off FDA attacks. This is all very thoroughly documented in the court records.
The victims here: lots of kids with astrocytomas since 1990.
I’m surprised that an organization that speaks out against fraud would produce such blatant misstatements and erroneous representations of historical facts. We will believe the press release and ignore the comment.
Is the rest of this newsletter as inaccurate?