Group worried over Dengvaxia scare on clinical trials

MANILA, Philippines — The Philippine Clinical Research Professionals Inc. (PCRP) has expressed concerns over the possible impact of the Dengvaxia vaccine controversy on the country as a venue for clinical trials.

PCRP founding member Jennifer Olive Arellano said sponsors for clinical trials might veer away from the Philippines as host country, to the detriment of patients who are looking for alternative treatment.

PCRP is a private organization that screens and polices clinical trials being held in the Philippines.

“There are patients who may need advance and new treatment, especially for cancer, and they usually turn to clinical trials as alternative,” she told The STAR on the sidelines of the “SalinSiyensiya” forum for the media of the Research Institute for Tropical Medicine on Friday.

Arellano noted that many patients, after exhausting available treatments, are inclined to participate in clinical trials in the hope that a new medicine could provide a cure.

She added they are worried “about miscommunication that the clinical trial (for Dengvaxia) was not finished yet when it was introduced in the Philippines” because it could harm the country’s reputation.

Grace Mendoza, another PCRP founding member, said the Dengvaxia controversy might also put in question the “capability” of the Philippines to do clinical trials and turn off foundations, philanthropists, pharmaceutical firms and other sponsors.

She also claimed the controversy might scare away participants in clinical trials. 

At present, the Philippines has a registry of clinical trials that patients can look at if they are searching for alternative treatment. 

Mendoza stressed there are stringent standards that must be followed before and while a clinical trial is being conducted in a country. 

But the Dengvaxia issue may send a message that the Philippines did not follow such standards, thus tainting the country’s image in the international clinical research community.

“It will really have an impact because drug research is very competitive. It means that sponsors will place their clinical research in a country which they think is capable. If they think there will be a problem here, they will go to other countries,” she added.

Downward trend

Arellano also said prior to Dengvaxia, there was already a downward trend in clinical trials in the Philippines because sponsors find the country’s regulatory approval as “not that fast.” 

She expressed concerns that the Dengvaxia controversy might give sponsors more reason to leave the Philippines out.

“If the development of a drug is being hurried up, they will prioritize countries that could speed up the approval process, plus the fact that now, there are concerns (about Dengvaxia), sponsors are worried that the approval process will be longer,” she added.  

The controversy on Dengvaxia vaccine that was given to thousands of Filipino students broke out after its manufacturer, Sanofi Pasteur, said it should not be administered to patients who never had dengue because it might lead to more serious ailments.

While no deaths could be linked directly to the vaccine, the developments that followed Sanofi’s announcement, including congressional hearings and filing of charges, have affected the immunization programs of the country, health officials said.