Why Does The FDA Deny Access To Alternative Cancer Treatments?

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http://www.ouralexander.org/war1.htm

 

 

" War on Cancer " : Why Does The FDA Deny Access To Alternative Cancer

Treatments?

 

by Michael Horwin

 

This article originally appeared in the Fall 2001 edition of the

California Western Law Review, Volume 38, Number 1. The copyright of

this article is owned by the California Western Law Review. All

rights are reserved and it may not be reproduced or transmitted

without written consent of the California Western Law Review. It is

presented here because the author obtained special permission.

 

(The following is the introductory section of the article without the

original footnotes;

to read the entire article with footnotes, download this Word

document.)

 

Dedicated to my son Alexander Roy Horwin. He was denied a potentially

life saving treatment by the FDA on September 21, 1998. He died on

January 31, 1999. He was 2 1/2 years old and had his entire life

before him.

 

 

 

" I love purple.

I love yellow.

I love red.

Daddy, I love everything. "

 

 

Alexander Horwin walking the halls of the Hematology-Oncology floor

of Children's Hospital Los Angeles, looking at the brightly colored

paintings on the walls while undergoing his second chemotherapy

session in November, 1998. He would die in his mother's arms three

months later at the age of 2 ½ years old.

 

 

In February 1994, two and a half year-old Dustin Kunnari was

diagnosed with a deadly brain tumor called medulloblastoma , which

was the size of a golf ball. The neurosurgeon skillfully removed 75%

of the tumor, but surgery alone was not an adequate treatment and

Dustin's parents were referred to a chemotherapy trial. The doctors

informed the Kunnaris that the side effects of the chemotherapy could

include " bone pain, hearing loss, irreversible damage to the kidney

and bladder, destruction of the immune system, learning disabilities,

sterility, and, leukemia. " " In addition, the doctors could not name a

single child who had done well following any of these treatments. " To

Dustin and his family, this " cruel regimen with so little hope " was

less than promising.

 

In April 1994, the Kunnaris traveled to Houston to consult with

Stanislaw Burzynski, M.D., Ph.D. Dr. Burzynski used an innovative and

nontoxic therapy to treat brain tumors. Because Dustin still had some

tumor left in his brain, Dr. Burzynski explained that the efficacy of

his therapy could be determined rapidly. If, after six weeks, the

remaining tumor had shrunk or disappeared then the treatment was

working. If the treatment failed, the Kunnaris could have the

orthodox oncologists administer the more toxic therapies—chemo and

radiation. For six weeks Burzynski's treatment,

called " antineoplastons, " was administered to Dustin. After this

trial period was over, Dustin had a MRI (magnetic resonance imaging)

of the brain at a local hospital. Consequently, the Kunnaris were

rewarded with good news: the remaining tumor in Dustin's brain was

gone. The boy stayed on the antineoplastons, but a year later, a

second tumor appeared approximately one inch in diameter. Dr.

Burzynski increased the dose of his therapy and the second tumor

dissolved. Today, over seven years from his initial diagnosis, Dustin

is a normal, healthy, cancer-free boy with no side effects from the

treatment.

 

In August 1998, four years after Dustin was originally diagnosed, my

son, two-year-old Alexander Horwin was diagnosed with

medulloblastoma, the same tumor as Dustin Kunnari. Alexander was a

strong, handsome and intelligent child with curly brown hair and big

brown eyes who could already speak English and French. He loved

exploring the ocean and its mysterious tide pool animals with his

Daddy. And he loved riding fast in his stroller along the boardwalk

as his Mommy roller-bladed behind him.

 

Surgeons removed the entire tumor, but told us that without further

treatment, this cancer would return and take Alexander's life. Like

the Kunnaris, we looked for the best treatment for our son, one that

was the least toxic and offered the greatest potential for survival

and quality of life. After extensively researching the medical

treatment options, we also chose Dr. Burzynski's therapy for

Alexander. This time, however, the outcome would be different.

 

After bringing Alexander to Dr. Burzynski in Houston on September 21,

1998, we were stunned to learn that the FDA would not allow us to use

this therapy. Dr. Burzynski explained that the FDA controlled his

protocols and required children like Alexander to first undergo

the " standard treatment " of chemotherapy and/or radiation. Once the

cancer returned on the standard treatment, then Burzynski could treat

our son.

 

This news seemed inconceivable to us. After enduring two brain

surgeries, Alexander was now tumor-free and ready for the best cancer

therapy that would stop the disease from reoccurring. There we sat

before Dr. Burzynski in a brightly lit examination room in his

clinic. In that clinic was the medicine that could potentially save

our son's life. The doctor was willing to treat Alexander. We,

Alexander's parents, wanted the treatment. Alexander wanted to be

well again. But even though all of the parties in interest were

willing, our decision had no weight or value. Instead, a decision

made by a bureaucrat two thousand miles away would trump the

determination of the parents and the doctor. This bureaucrat had

never met Alexander, and did not know anything about our son's

medical history. He did not love Alexander and yet his decision was

final.

 

With no other treatment options available, we returned to Los Angeles

and reluctantly agreed to have chemotherapy administered to

Alexander. We were devastated to learn that if our son was one of

the " lucky ones " to survive, the side effects of chemotherapy could

include:

 

Low hemoglobin, low white blood cells, low platelets, infection, need

for blood transfusion, need for platelet transfusion, pain, nausea,

vomiting, hair loss, skin injury, heart damage, lung damage, liver

damage, kidney damage, loss of hearing, small stature, hormonal

problems such as low growth hormone or low thyroid hormone,

infertility, second cancer, intellectual decline, worsening of

neurological symptoms, ineffectiveness, and death.

We continued to look for other options outside of the United States.

Three months after starting chemo, and while receiving the

third " round " of this therapy, Alexander started complaining of

pain. " Mommy, I have pain here and here, " he repeated pointing to his

head and back. On January 11, 1999, a CT scan of Alexander's head was

done at Children's Hospital in Los Angeles. The doctors assured us

that they could see " nothing " and sent us home. Alexander's pain

persisted. Finally, on January 18, 1999, we demanded an MRI. To our

horror it revealed thirty new tumors throughout Alexander's head and

spine. We were told that Alexander had a " few days perhaps " to live

and he was discharged home from the hospital with decadron, morphine

and hospice care. Having endured chemotherapy and having the cancer

return, Alexander now met the FDA requirements and qualified for Dr.

Burzynski's therapy. Our son was so sick that we charted an air

ambulance to fly him from Los Angeles to Houston. But the cancer was

too widespread. My son, Alexander Horwin, died on January 31, 1999.

He was only two and a half years old.

 

Although Dr. Burzynski's therapy has been in limited use since 1976

and has cured a significant number of people with malignant brain

tumors when he has been permitted to do so; his therapy is still not

FDA approved. In 1983, Dr. Burzynski approached the FDA to initiate

the approval process. In 1993, Burzynski's Investigation New Drug

application (IND) was finally accepted and clinical trials began.

Today, however, after eight years of trials, the therapy is still not

FDA approved. In fact, between 1994 (when two and a half year-old

Dustin Kunnari was diagnosed) and 1998 (when two year-old Alexander

Horwin was diagnosed), the FDA tightened its criteria regarding which

children can be treated with the non-approved protocol. Since 1996,

these criteria have required that children with operable brain tumors

must first undergo chemotherapy and/or radiation and have the cancer

return before Dr. Burzynski can treat them. Even then, the FDA must

personally accept the patient onto the protocol before the therapy

can begin. If the FDA says " no, " there is no appeal. Unfortunately,

Alexander was diagnosed after 1997, and therefore, the FDA required

that he first be treated with chemo and/or radiation before he could

avail himself of Dr. Burzynski's nontoxic therapy.

 

The FDA is charged with determining what drugs are approved for

interstate commerce and under what circumstances non-approved drugs

may be accessed. An examination of the FDA's position in relation to

cancer sufferers, especially children, will reveal that this agency

has consistently and steadfastly come between patients and the non-

FDA approved treatments recommended by the patient's medical doctor.

The juxtaposition of the stories of the children introduced supra—

Dustin Kunnari, who was fortunate enough to be treated and who is

alive and healthy, and Alexander Horwin, who was not treated, allowed

only orthodox therapy, and who died five months after being diagnosed—

raises a number of disturbing legal issues that will be discussed in

this note.

Part I will introduce our nation's war on cancer and discuss how well

the war has been waged. Part II will survey how the law has

consistently limited patient access to non-FDA approved cancer

therapies. It will discuss the role of the FDA and the perspective of

the U.S. Supreme Court. Part III will focus on the Access to Medical

Treatment Act. Four Congresses have attempted to pass this

legislation that would allow patients access to non-approved

therapies, but the FDA has successfully argued against its passage

each time. The agency's medical-policy positions will be identified

and critiqued.

 

Parts IV through VII focus on solutions. Overcoming the FDA's policy

arguments is essential to having the Access to Medical Treatment Act

passed which would allow children to have access to the therapy that

has the best chance of saving their lives. Therefore, these medical-

policy suppositions will be critically examined. In Part IV, the

assumption that standard cancer therapies are always best will be

challenged. In Part V, the importance of requiring thorough clinical

testing of new cancer drugs will be considered. Part VI will discuss

whether bureaucrats should be placed in a position of trumping the

medical decisions of a patient and their physician. Part VII will

address the unsuspected role that economics may be playing in the

multi-billion dollar cancer industry. Finally, Part VIII will

conclude by arguing that the current state of the law in respect to

cancer therapy is antithetical to our country's core values.