First, to do patients no harm
I wish to comment on the raging “stem cell” controversy extensively discussed in Dr. Rafael Castillo’s Medical Files column in the Inquirer.
It has to be emphasized that stem cell therapy (SCT) remains a stem cell “hypothesis” (SCH) rather than a proven therapy, in the absence of evidence-based local data. As of this date, we don’t have any published clinical study in peer-reviewed scientific journals.
Local studies should be done with preferably a “sham” procedure as control to eliminate the so-called placebo or psychological “positive bias perception” effect. In a “sham” procedure, the patient undergoes exactly the same procedure but receives an inactive solution (placebo) instead of the therapeutically active or “test” solution. There may be some ethical issues with this procedure, but it should be weighed against the overall risk-benefit of the study.
SCT/SCH processing procedures, currently practiced “secret” formulations, should also be evaluated vis-à-vis a “gold standard” comparator since many factors can come into play, which can account for the perceived improvements felt after receiving SCT—as claimed in unpublished, nonpeer-reviewed reports. Patients may actually be spending so much for nothing.
Our SCT practitioners and regulatory officials should also note that even “autologous” cells processed in the laboratory may already behave as a “foreign body” if introduced back to the same patient. This can trigger some reactions which may not be noted immediately upon administration of the SCT but only after some time, such that these reactions are no longer attributed to the SCT. Hence, a study protocol, which will monitor such reactions for a given period of time after SCT administration, should be required.
Seasoned scientists would counsel us that whatever so-called “positive cell capabilities” noted in the laboratory cannot be assumed to happen when the stem cells are introduced back to the patient, because the cells have been introduced already to a different type of physiological “foreign environment.” Further studies are needed to explore possible changes in the “behavior” of the stem cells when infused back to the patient to obviate a rejection.
Patients should be made aware of these possible complications of SCT/SCH. If they can afford the steep price they are supposed to shell out for SCT, they must be educated enough to know what is the real score so they can make an informed and wise decision. All of us physicians should not only ask ourselves—what did we do wrong or did not do right? We should also make ourselves accountable for what we did not explain well to our patients.
Finally, I echo Doctor Castillo’s call in his column that the coalition of various medical organizations should regard the Department of Health-Food and Drug Administration as an ally, rather than an adversary, in the pursuit of appropriate health care and in weeding out unscrupulous and unethical practices. I agree with Doctor Castillo that the DOH-FDA and the doctors’ coalition can achieve more as one team, instead of being rivals belonging to dissenting factions.
Both sides must remember that medicine is not an exact science. Regardless of orientation, doctors and other health care givers share common laudable missions—to make patients well; and first, to do them no harm.
Dr. Ramon F. Abarquez Jr. is emeritus professor at the University of the Philippines College of Medicine.
