Stem cell debate: Innovation or safety?

Differences in body make-up

To Bernal, the difference in body make-up at the molecular level makes the process "very complicated." This complication extends to the design of clinical trials.

He said it would be hard to randomize groups and compare them, given that no two patients are the same. 

"It is exactly because each patient is different and exactly because only some get cured that we need randomized clinical trials," Dans countered.

TRIALS NEEDED. Dr Antonio Dans stresses the need for clinical trials, as they are designed to determine efficacy and safety of a drug. Photo by Rappler/Jom Tolentino

TRIALS NEEDED. Dr Antonio Dans stresses the need for clinical trials, as they are designed to determine efficacy and safety of a drug.

Photo by Rappler/Jom Tolentino

Drugs with special permits

To be sure, not all drugs administered to patients here have undergone clinical trials in the country. There are medicines provided with special permits that allow administration to a patient. 

Once the necessary permit is secured, the unregistered drug can be imported and used. 

Dr Tito King, head of the FDA division that grants these special permits, said the basic rationale is that the "welfare of the patient should not be held hostage by registration."

These special cases that allow the importation of locally unregistered drugs include: 

Drugs administered by hospitals for essential use are usually for rare diseases, where the local market is too small that no pharmaceutical company has invested in its sale in the country.

But do stem cell products fall within these categories? 

Last resort

Stem cell products are special, given their potential. But they are not part of the "standard of care," that is generally accepted as a mode of treatment. 

Often, they must be administered as a last resort when all other treatments have failed.

"Patients who come for this procedure are desperate for improvement, because of lack of significant improvement from the [standard] medication or treatment for many years,Lucero said. 

The criterion that may permit experimental stem cell therapies is "compassionate use" meant for terminally ill patients with a life expectancy of 6 months or less.

There are, however, stem cell transplant practitioners who offer stem cell therapy for conditions other than terminal illnesses such as diabetes, stroke, or even simply aging. (READ: 'Suspend deceptive stem cell transplant doctors')

PATIENTS' DIFFERENCES. Dr Samuel Bernal of The Medical City says no two patients are the same in the u0022molecular level,u0022 making clinical trials for stem cell therapy rather complicated. Photo by Rappler/Jom Tolentino

PATIENTS' DIFFERENCES. Dr Samuel Bernal of The Medical City says no two patients are the same in the u0022molecular level,u0022 making clinical trials for stem cell therapy rather complicated.

Photo by Rappler/Jom Tolentino

Give patients a chance

Members of the PSSCM say the treatment offers hope that cannot be ignored. 

"I inform them of the possibility. No promise of cure," said Lucero, adding that there is nothing wrong with administering the therapy so long as the patient agrees to it after being informed about its limitations. 

Another stem cell transplant physician, Dr Cristina Puyat, said the curative effects differ but there's qualitative improvement for sure.

"Some patients really get cured, [while] some don't. What definitely happens is that there's improvement in the quality of life. So, I think, patients should also be given the chance," she said.

To dissenters, however, this "chance" comes at the expense of ethics and protocol supposedly valued by the medical profession. – Rappler.com