A 'daughter vaccine'
A 'daughter vaccine'
Updated 00:52am (Mla time) Jan 08, 2005
By Rina Jimenez-David
Inquirer News Service
Editor's Note: Published on page A13 of the January 8, 2005 issue of the Philippine Daily Inquirer
THERE'S an exciting medical experiment going on that holds particular promise for all the world's women, and the Philippines is part of this groundbreaking research. The experiment is the ongoing "Patricia" clinical research trial for the development of a vaccine against cervical cancer, the fifth most common cause of death from cancer in women worldwide.
In the Philippines, the most common cancer afflicting women is breast cancer (we have the highest rate of breast cancer incidence in all of Asia), but more women die from cervical cancer. The reason for this, say medical authorities, is that many women with cervical cancer come for consultation only when it is too late, or not at all. Which is ironic, if not tragic, because cervical cancer is so far the only form of cancer whose cause is known and detectable. It is also easy to diagnose even at an early stage and develops over time, which means a woman diagnosed early enough has time to get treatment and even get cured. And so far, cervical cancer is the only form of cancer for which a vaccine is being developed.
The lead investigator for the "Patricia" trial in the Philippines is Dr. Genara Manuel-Limson, an obstetrician-gynecologist and gynecologic oncologist (or specialist in cancers of a woman's reproductive system), based at the Makati Medical Center. Asked why she agreed to head the clinical trial in the country, Dr. Limson said it was the "chance to address the high morbidity (illness) and mortality rate of cervical cancer in the Philippines." She added: "Eighty percent of all cervical cancers in the world occur in Asia, and of those cases, 75 percent are in the Philippines."
Dr. Limson's associate, Dr. Glenn Benitez, says his "dream" is for "cervical cancer to go the way of hepatitis B," which has been largely controlled through widespread use of vaccines.
* * *
DOCTORS Limson and Benitez stress that the "Patricia" trial, which is taking place in 14 countries, has been approved by both the US Food and Drug Administration and the local Bureau of Food and Drugs (BFAD). The ongoing trial is on its third phase, having begun in 1982, and Dr. Benitez says that if all goes well and the results are satisfactory, we could be looking at the vaccine becoming available in as little as five years.
Aside from Makati Med, other trial sites are the Calamba Medical Center, San Pedro (Laguna) Medical Center, and De La Salle University-Cavite, with other medical establishments to be accredited soon.
For the trial to be successful, though, volunteers are needed. If you are a woman aged 15-25 years, in good health, and not pregnant and not intending to become pregnant in the next eight months, then you're qualified to be a volunteer. Volunteers, according to handouts prepared by the vaccine manufacturer GlaxoSmithKline, will receive "three doses of a vaccine over a six-month period." For research purposes, the trial consists of "double-blind" samples, that is, neither the dispenser nor the receiver knows who among the volunteers will be receiving a dose of the experimental vaccine or a "control" vaccine against hepatitis A infection, which causes liver disease.
* * *
IN ALL, a volunteer will have to commit to 10 scheduled visits over the course of four years, during which she will not only receive the vaccines, but will also be regularly monitored, by some of the country's top ob-gyns, for her obstetrical and gynecological health.
Some of the procedures a volunteer will have to undergo include regular blood tests and pelvic exams to check not only how well the vaccine is working, but also if the volunteer has contracted an HPV infection, if she has contracted a different sexually transmitted infection, or if she is at risk of developing cervical cancer.
"If any of these is the case, you will receive free medical treatment to address the problem," the handouts declare.
Strictly speaking, the experimental vaccine is directed at preventing infection by the human papillomavirus, or HPV, which is a "very common" infection transmitted during sexual intercourse (against which even the condom offers no protection!), and two types of which -- T16 and T18 -- have been linked to two-thirds of all cervical cancers. "So if we succeed in vaccinating young women from just these two types of HPV," asserts Dr. Limson, "then we would have prevented 75 percent of all cervical cancers!"
Overall, some 13,000 volunteers are needed from around the world. Notes the handout: "The global nature of the clinical research trial is important -- it will show how well the vaccine works in women from many different ethnic groups and cultures." And, I might add, enjoying varying standards of health care, too.
* * *
THIS experimental vaccine has been dubbed a "daughter vaccine," in anticipation that parents will be the ones most motivated to make it available to their daughters who, should the trials prove successful, will no longer run the risk of developing cervical cancer once they become sexually active.
Unfortunately, in the Philippines, some hang-ups about sex and medical experimentation are standing in the way of a successful trial. Dr. Wen del Rosario, a member of the clinical research team in Laguna who first alerted me to the ongoing trial, says there is still some controversy over making the vaccine available to, say, 13- or 14-year-old girls. "It's like you're anticipating that they will be having sex soon," she says.
Dr. Limson also admits that it has been difficult for her team to attract volunteers, who are discouraged by friends and family who claim that "you will only be experimented upon."
"I think it points to a prevailing cynicism and lack of trust among our populace," she says.
Updated 00:52am (Mla time) Jan 08, 2005
By Rina Jimenez-David
Inquirer News Service
Editor's Note: Published on page A13 of the January 8, 2005 issue of the Philippine Daily Inquirer
THERE'S an exciting medical experiment going on that holds particular promise for all the world's women, and the Philippines is part of this groundbreaking research. The experiment is the ongoing "Patricia" clinical research trial for the development of a vaccine against cervical cancer, the fifth most common cause of death from cancer in women worldwide.
In the Philippines, the most common cancer afflicting women is breast cancer (we have the highest rate of breast cancer incidence in all of Asia), but more women die from cervical cancer. The reason for this, say medical authorities, is that many women with cervical cancer come for consultation only when it is too late, or not at all. Which is ironic, if not tragic, because cervical cancer is so far the only form of cancer whose cause is known and detectable. It is also easy to diagnose even at an early stage and develops over time, which means a woman diagnosed early enough has time to get treatment and even get cured. And so far, cervical cancer is the only form of cancer for which a vaccine is being developed.
The lead investigator for the "Patricia" trial in the Philippines is Dr. Genara Manuel-Limson, an obstetrician-gynecologist and gynecologic oncologist (or specialist in cancers of a woman's reproductive system), based at the Makati Medical Center. Asked why she agreed to head the clinical trial in the country, Dr. Limson said it was the "chance to address the high morbidity (illness) and mortality rate of cervical cancer in the Philippines." She added: "Eighty percent of all cervical cancers in the world occur in Asia, and of those cases, 75 percent are in the Philippines."
Dr. Limson's associate, Dr. Glenn Benitez, says his "dream" is for "cervical cancer to go the way of hepatitis B," which has been largely controlled through widespread use of vaccines.
* * *
DOCTORS Limson and Benitez stress that the "Patricia" trial, which is taking place in 14 countries, has been approved by both the US Food and Drug Administration and the local Bureau of Food and Drugs (BFAD). The ongoing trial is on its third phase, having begun in 1982, and Dr. Benitez says that if all goes well and the results are satisfactory, we could be looking at the vaccine becoming available in as little as five years.
Aside from Makati Med, other trial sites are the Calamba Medical Center, San Pedro (Laguna) Medical Center, and De La Salle University-Cavite, with other medical establishments to be accredited soon.
For the trial to be successful, though, volunteers are needed. If you are a woman aged 15-25 years, in good health, and not pregnant and not intending to become pregnant in the next eight months, then you're qualified to be a volunteer. Volunteers, according to handouts prepared by the vaccine manufacturer GlaxoSmithKline, will receive "three doses of a vaccine over a six-month period." For research purposes, the trial consists of "double-blind" samples, that is, neither the dispenser nor the receiver knows who among the volunteers will be receiving a dose of the experimental vaccine or a "control" vaccine against hepatitis A infection, which causes liver disease.
* * *
IN ALL, a volunteer will have to commit to 10 scheduled visits over the course of four years, during which she will not only receive the vaccines, but will also be regularly monitored, by some of the country's top ob-gyns, for her obstetrical and gynecological health.
Some of the procedures a volunteer will have to undergo include regular blood tests and pelvic exams to check not only how well the vaccine is working, but also if the volunteer has contracted an HPV infection, if she has contracted a different sexually transmitted infection, or if she is at risk of developing cervical cancer.
"If any of these is the case, you will receive free medical treatment to address the problem," the handouts declare.
Strictly speaking, the experimental vaccine is directed at preventing infection by the human papillomavirus, or HPV, which is a "very common" infection transmitted during sexual intercourse (against which even the condom offers no protection!), and two types of which -- T16 and T18 -- have been linked to two-thirds of all cervical cancers. "So if we succeed in vaccinating young women from just these two types of HPV," asserts Dr. Limson, "then we would have prevented 75 percent of all cervical cancers!"
Overall, some 13,000 volunteers are needed from around the world. Notes the handout: "The global nature of the clinical research trial is important -- it will show how well the vaccine works in women from many different ethnic groups and cultures." And, I might add, enjoying varying standards of health care, too.
* * *
THIS experimental vaccine has been dubbed a "daughter vaccine," in anticipation that parents will be the ones most motivated to make it available to their daughters who, should the trials prove successful, will no longer run the risk of developing cervical cancer once they become sexually active.
Unfortunately, in the Philippines, some hang-ups about sex and medical experimentation are standing in the way of a successful trial. Dr. Wen del Rosario, a member of the clinical research team in Laguna who first alerted me to the ongoing trial, says there is still some controversy over making the vaccine available to, say, 13- or 14-year-old girls. "It's like you're anticipating that they will be having sex soon," she says.
Dr. Limson also admits that it has been difficult for her team to attract volunteers, who are discouraged by friends and family who claim that "you will only be experimented upon."
"I think it points to a prevailing cynicism and lack of trust among our populace," she says.
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