Rejoinder to the stem cell ‘tempest’By Rafael Castillo M.D.
Philippine Daily Inquirer
First of two parts
Last Wednesday, the leaders of close to 30 medical organizations, composed of specialists from various fields, gathered at the office of the Philippine College of Physicians (PCP) to reassert their recommendations to the Department of Health (DOH) and the Philippine Food and Drug Administration (PhilFDA) to regulate stem cell treatment (SCT) in the country.
As we said in a previous column, many local practitioners are “jumping the gun” and, unfortunately, sprinting in the wrong direction with their unscrupulous administration of stem cells left and right for various medical conditions. Their medical practice has not been established as safe and effective for this experimental treatment.
Some medical colleagues were quoted as saying that these medical organizations that are sounding the alarm don’t realize that they are killing this promising treatment of the future. I don’t think so. They’re in fact protecting this potential form of treatment from practices that would compromise the safety of patients on the long term, and give it a bad name.
More local experience
In previous columns, we’ve encouraged more local experience on stem cell treatment under a research protocol—which is also one of the strong recommendations of the PCP and other medical organizations—so we could gain expertise on it and contribute to the world literature. Unfortunately to this date, there is only one published case report (a single case) in a peer-reviewed international journal.
It is estimated that for the last five years, at least 3,000 Filipinos were given stem cell treatment locally in the big centers and small stem cell clinics which have sprouted like mushroom in Metro Manila and other key cities in the country. It’s difficult to explain why there is no published report—other than the lone case report—of what has happened to all these patients given this experimental treatment.
The DOH and the PhilFDA should oblige all these centers to report the outcomes of all patients given the treatment. Obviously, no research controls were done to ascertain that whatever effect noted could be attributed to the treatment but if all data are faithfully reported—which I trust the big medical centers would—the PhilFDA can have an idea if there are any red flags with regard to safety that should merit a more thorough investigation.
Good clinical practice also dictates that for all investigational drugs like SCT, continued monitoring of these patients must be done long after the course of treatment had been completed since side effects or adverse reactions, including cancer, might only develop after several years.
Hopefully, Health Secretary Ike Ona and PhilFDA director Kenneth Hartigan-Go would strongly consider the suggestions of the various medical organizations to revise the DOH administrative order to further strengthen its regulatory impact on a rational stem cell practice in the country. Kenneth is also a current officer of the PCP, and I’ve always known him as a very intelligent and idealistic doctor, so I’m sure he knows where the doctors are coming from. With the two hats he’s wearing, he’s in a good position to bridge the gap between the doctors and the DOH.
It’s just too bad that emotions have gotten in the way between both sides. This only blurs the issues and draws both factions further apart. Pride and bruised egos have to be set aside and the issues have to be discussed in an objective and dispassionate manner.
When groups bond together, there is a risk of developing a so-called “mob mentality,” which could make an alliance unfavorably aggressive rather than just being constructively assertive. Demands may be made without giving the other party the chance to study carefully and consider what are being recommended.
Calls have even made for Secretary Ona to step down. Although I agree that the health chief might have committed some lapses in judgment, such as agreeing to be honorary chair of a stem cell society group that claims to be the specialists on stem cell treatment and to have the competence to accredit doctors who would be given the title of “Fellow” or specialist, this should not eclipse all the good things he has done for the DOH and healthcare delivery in the country. His overall performance is still on the high positive side. But Secretary Ona should also remember that sometimes there are isolated but defining situations like this which can draw the line where he really stands on matters of public safety. We pray that he be enlightened and properly guided when he makes the final decision(s) on how to regulate stem cell practice in the country.
The same goal
It’s sad that the DOH and the medical organizations have been pictured in various media as straddling the fence when it comes to the stem cell controversy. The way I see it is that both sides actually have the same goal—to eliminate irrational and unscrupulous practice of stem cell medicine in the country—but they somehow differ in the details of the methodology to achieve it. I know there have been several dialogues already, but they just need to talk more with cooler heads around, and perhaps get the media out of it for an agreed period to show good faith toward each other.
The medical groups have already made their recommendations, most of which I strongly support, but we should leave it to the DOH and the PhilFDA to make the final decision on what regulatory policies are to be implemented to regulate local stem cell practice. Perhaps someday, it’s very likely that the health secretary and the PhilFDA director will come from the ranks of our current leaders of the medical organizations and then they’ll be accorded the same respect and courtesy.