Experts warn against senator’s bill

Brownback seeks access to experimental drugs for terminally ill cancer patients

A bill sponsored by Sen. Sam Brownback is intended to help terminally ill patients, but a leading medical journal Thursday warned against the consequences.

Brownback, R-Kan., introduced the “ACCESS Act” in November, a bill that would give dying patients a chance to use experimental drugs to halt their disease – before the federal Food and Drug Administration has given final approval to those drugs.

“I have been pushing for us as a country to end deaths by cancer in 10 years,” Brownback said in a conference call Thursday with the Kansas media. “One of the keys to do that would be to get a lot more experimentation on drugs (that are still undergoing FDA clinical trials) … with patients who have no other option.”

But Thursday’s New England Journal of Medicine said such efforts would make it harder for researchers to know which drugs are effective.

“Only 11 percent of drugs – and only 6 percent of cancer drugs – that enter clinical testing are ultimately approved,” the journal reported. “The rest either prove to be too toxic or do not work.”

Dr. Richard Barohn, a neurologist and researcher at Kansas University Medical Center, said he worked with terminally ill patients and understood the desire to speed drug approval but had serious doubts Brownback’s proposal was the best solution.

“I run the ALS (Amyotrophic Lateral Sclerosis, or Lou Gehrig’s disease) clinic here … so I am very sympathetic with the urgency to find cures and treatments, and I’m involved in a lot of clinical trials trying to find treatments,” Barohn said.

But the doctor said clinical trials often turned up “horrible side effects” that were previously unknown. And giving them to patients so close to death might give false hope.

The “chances of a miracle drug that retrieves them from death is very low,” Barohn said.

Brownback’s bill – and a lawsuit against the FDA – is sponsored by Abigail’s Alliance, a Virginia-based advocacy group. Steve Walker, a member of the group, said Thursday his wife died of colon cancer in 2003, while the FDA was still awaiting approval on drugs that might have helped her.

He said the FDA is too “rigid and process-oriented.”

“We’re trying to change the system so it’s responsive to patients,” he said. “Once you know that a drug works, you need to make it available. The system doesn’t do that.”

Brownback’s bill has been sent to committee but given no hearing. He said Thursday that current “cocktails” of drugs that have curbed the deadliness of AIDS were made available to patients before final approval, saving lives and pioneering the treatment.

“It has worked for us in the past, particularly in dealing with the AIDS situation,” Brownback said, “and I want to apply it to cancer.”