US panel urges more access to experimental drugs

[Guest guest]

US panel urges more access to experimental drugs

By Ault

BETHESDA, Md., Jun 08 (Reuters) - US advisers on Thursday urged regulators

and pharmaceutical companies to set up distinct ground rules so more

seriously ill cancer patients can try experimental drugs outside of clinical

trials.

A meeting of a Food and Drug Administration advisory panel was aimed at

addressing rising complaints that trials are hard to find and even harder to

get into.

Patients also charge that drug makers do not help them enroll in an FDA

program designed to ensure that the sickest can, as a last resort, try an

experimental therapy that might offer additional survival or better quality

of life.

The FDA advisers did not formally vote, but a majority said drug companies

should let very sick patients get experimental therapies as soon as there is

reasonable evidence they are safe and effective.

The FDA usually follows its panels' advice.

Most panelists suggested the end of the second phase of testing as a

benchmark. But they said patients should meet certain criteria before

getting the drugs. They cannot be eligible for clinical trials and must have

failed every available therapy, the advisers said.

A majority said drug companies also should think about granting requests to

seriously ill patients who are willing to try an experimental drug in lieu

of a therapy that may offer only a modest survival benefit.

Erwin, director of the Marti Cancer Research Foundation in

Vacaville, California, argued cancer patients should be able to receive a

drug in the earliest stage of study, known as Phase I, as long as they were

being treated at a trial site and monitored by a researcher.

But panelists were upset by that notion.

" I don't want to say we are horrified at this idea, but we are strongly

against it, " said Chairwoman Stacey Nerenstone, an oncologist at Hartford

Hospital's Helen & Harry Gray Cancer Center in Connecticut.

In Phase I, a drug's effectiveness and side effects are not well understood.

Giving a vulnerable patient a drug at that stage poses a strong risk of

harm, Nerenstone said.

Currently, the FDA leaves it up to drug companies to decide when individuals

can be given experimental therapies outside of trials.

But drawing the line has become more difficult with increasing reports of

" breakthrough " therapies that cause thousands of patients to call drug

companies at once, all demanding that they have a shot at a cure.

A May " 60 Minutes " broadcast on CBS television on the topic added more fuel

to the fire. Panelist Jody Pelusi, an oncology nurse at Phoenix Indian

Medical Center, said a physician at her clinic had to add staff for a day to

handle a barrage of phone calls from patients wanting to know why they had

not been told previously about some of the experimental drugs cited on the

show.