It is surprising that John McKemie can even walk.

His body has been poked, prodded and scanned.

“At least 20 to 25 different types of chemo,” McKemie said.

Twenty years ago he was diagnosed with CML leukemia, followed by skin cancer and prostate cancer.

It is patients like McKemie, who are staring death in the face, who are at the heart of a debate over who can buy drugs still being developed.

“My personal opinion is that each individual should have the right to do what they need to do to try and sustain life,” he said.

That argument is supported by a Virginia-based group called the Abigail Alliance, which believes “terminally ill patients, in consultation with their doctors, have a right to early access to experimental drugs  ... that show signs of safety and effectiveness.”

Standing in the way is the Food and Drug Administration, which decides which drugs go to market.

The FDA argues it already allows early access to drugs through clinical trials, many them offered at the Medical Center.

But critics say not enough patients qualify for those trials. 

FDA lawyers have said: “Broad access to experimental drugs could harm patients, and undermine the incentive for them to participate in clinical trials.”

“I want regulation that protects people from harm, but it does not protect sick people from progress,” M.D. Anderson Cancer Center Dr. Emile Freireich said.

Dr. Freireich has been an oncologist for half a century and is a passionate advocate for early access to drugs.

He said the FDA is too risk-averse.

“It’s wrong because people have to decide for themselves,” he said. “Do you want a law that says you can’t ride a car because your mortality is x?

“We all assume risk if we are informed, and we take the risk we choose to take,” Dr. Freireich said.

The debate over early access to drugs ultimately won’t be decided by doctors or the FDA, but by the courts and Congress.

The early access act has been on Capitol Hill for three years, slowly gaining support.  And the Abigail Alliance has sued the FDA, saying patients have a constitutional right to assume the risk of taking an unproven drug.

A decision is expected in a few months.

For McKemie there is only one answer.

“I do think we should expand the level of trials or expand the level of access to those patients,” McKemie said.

Is early access to drugs about false hope? Or the only hope?

The FDA errs on the side of caution, while critics say it’s time for the government to get out of the way of patients who have run out of options.