new news - history of the medical establishment revisited Part 2

[Guest guest]

02:00 AM Oct. 15, 2002 PT

 

The FDA does have two programs to allow terminal cancer patients to

access non-approved therapies currently in trials: the

Investigational New Drug Application (IND) and a " single-

patient, " " emergency " or " compassionate IND. "

 

The FDA approves these applications on a case-by-case basis.

 

 

 

" The FDA doesn't necessarily decide based on the drug; it is based

on the protocol of the scientific research, " said Laura Bradbard, a

spokeswoman for the agency.

 

But in most cases, patients can participate in these programs only if

no comparable treatment alternative is available.

 

" What does this mean? There is no case law on point, so currently it

means whatever the FDA decides, " wrote Michael Horwin in his

article " War on Cancer " : Why Does the FDA Deny Access to Alternative

Cancer Treatments? published in the California Western Law Review.

 

Horwin, previously a health-care administrator, was so outraged by

his son's and other children's treatment that he became an attorney,

hoping to change the law.

 

Critics say patients and physicians, not the FDA, should have the

power to make decisions about personal health care.

 

" If we're talking about protecting the public at large, that's quite

a different matter from one sole party who is going to die by all

accounts and really needs the greatest sympathy and protection from

the government, " said Jonathan Emord, a principal at the law firm

Emord and Associates in Washington, D.C.

 

But some doctors say the FDA provides a valuable service and is quick

to approve exceptions for terminal cancer patients.

 

Dr. Thomas Wagner, head of cancer research at the Greenville Hospital

System in South Carolina and a professor of molecular biology at

Clemson University, described a scenario in which one of his patients

died in pain and penniless because of a so-called " natural healer. "

 

" The FDA is a much more benevolent organization than people seem to

understand. In every case with every protocol there are exceptions, "

Wagner said.

 

In his experience, Wagner said, the FDA has been efficient about

approving experimental drugs in special circumstances, although he

said traditional therapies tend to get approved more often.

 

The Horwins and others have lobbied for change, partly in the form of

the Access to Medical Treatments Act (AMTA).

 

The bill hasn't made much progress.

 

" The AMTA must be passed by Congress, though -- the same Congress

that over the years created most of the problems in the first place, "

Chowka said. " It's not surprising therefore that the AMTA has been

languishing in Congress for almost a decade. "

 

Some critics say that chemotherapy drugs remain the status quo

because they represent a multi-billion-dollar monopoly.

 

According to the National Cancer Institute, 1.3 million Americans

will be diagnosed with cancer this year.

 

" Alexander lived only five months after being diagnosed and yet his

medical bill totaled nearly $250,000, " Horwin said. " If you take even

one-half of $250,000 and multiply it by 1.3 million people, the

dollars are staggering. "

 

Since 1971, the National Cancer Institute has spent $44 billion

searching for a cure.

 

However, between 1973 and 1991, the cancer death rate increased,

according to the National Cancer Institute. From 1991 to 1998, the

death rate decreased, but there was no overall percentage change in

the death rate between 1973 and 1999. Researchers predict that the

overall cancer burden in the United States will increase.

 

" Our son is dead, but he generated over a quarter of a million

dollars in revenue for the cancer industry within five months. As my

wife and I said when we testified in front of Congress on June 7,

2000, cancer victims, especially children, should not be used as

profit centers, " Horwin said.

 

Jack and Mariann Kunnari faced the same tragic situation as the

Horwins four years earlier.

 

Their son Dustin was diagnosed in 1994 with medullablastoma. Doctors

recommended surgery, radiation and chemotherapy, and told them about

the devastating side effects.

 

Since doctors said Dustin had only four months to live, the Kunnaris

wanted to keep him as comfortable as possible in that short time.

 

" We just wanted him to have a quality of life, " Mariann Kunnari

said. " If he lived a year we would be happy with that -- even if he

lived six months. "

 

Like the Horwins, the Kunnaris found Dr. Burzynski. When they told

their doctors they were thinking about this option, they were warned

there was a chance social workers would step in and force Dustin to

receive the traditional therapies.

 

" As if it isn't stressful enough to choose the best possible

treatment for your child, " Kunnari said. " Then to be threatened with

having him taken away so they could give him a treatment that could

kill him -- it was unbelievable. "

 

But the Kunnaris were lucky. The FDA tightened its regulations in

1997, saying patients had to try approved therapies without success

before going to Dr. Burzynski. But in 1994 the Kunnaris were not

bound by this rule.

 

Dustin received Burzynski's treatment for four years. Eight years

later, Dustin is tumor-free, healthy and off medication.

 

" You would never know he was sick, " his mother said.

 

 

 

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