WHO FACT SHEET by MikeJenny

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									WHO FACT SHEET                      TETANUS TOXOID CONTROVERSY, PHILIPPINES



Introduction
A situation arose in 1995 wherby tetanus toxoid being administered in the Philippines
immunization programme became discredited. We provide on this web site two versions
of the story:
     The WHO summary report "Concerns for the safety of Tetanus Toxoid in the
        Philippines 1995."
     An in-depth report provided by a team of Philippine social scientists led by Pilar
        Ramos-Jimenez.

Concerns for the safety of Tetanus Toxoid in the Philippines 1995
In the spring of 1995, an international « pro-life » organization spread rumours that the
tetanus toxoid vaccine (TT) being administered to women of childbearing age by
immunization programmes in developing countries was laced with a contraceptive
hormone. In a press release circulated via the internet to its affiliates in more than 60
countries, the organization, Human Life International (HLI), said tests of TT carried out
in Mexico had shown it to contain the pregnancy hormone, human chorionic
gonadotrophin (hCG). Tests in the Philippines performed by local hospital labs using
pregnancy test kits also reportedly showed the presence of hCG in TT. The organization
alluded to reports that "millions of women in Mexico and the Philippines have
unknowingly received anti-fertility vaccinations under the guise of being inoculated
against tetanus". It charged the WHO and UNICEF of using these women as
"uninformed, unwitting, unconsenting guinea pigs" in several countries with high
population growth rates, notably Mexico, Nicaragua, Philippines and Tanzania.
With support from WHO/GPV's Vaccine Supply and Quality unit (VSQ), six independent
labs in five countries ran tests on TT from seven different manufacturers, including those
supplying the four countries affected directly by the HLI campaign. All the tests were
negative. GPV director Dr Jong-Wook Lee declared in a WHO statement issued in July
1995 that the HLI rumours "are completely false and are totally without any scientific
basis".

The facts, according to the GPV
 Immunization of women of childbearing age with between two and five doses of TT
   protects their future offspring against neonatal tetanus. In a drive to eliminate this
   often-fatal diseases as a public health problem throughout the world TT immunization
   has been stepped up over the last four years in many countries.
 A small trial of contraceptive vaccine using hCG coupled to tetanus toxoid to enhance
   immunogenicity was reported by Indian researchers in 1994 (WHO was in no way
   connected with this trial). This report could have triggered the HLI campaign.
 The reported presence of hCG in the Mexican and Philippine tests of TT was clearly
   shown by subsequent lab tests to be below the limits of accuracy of the test kits used
   and was probably related to interference from the adjuvant and preservatives used in
   the vaccine. The findings of the Mexican and Philippine tests were called "an artifact
   rather than a true value" by Professor Salvatore Mancuso of the Vatican's Catholic
   University of the Sacred Heart. The subsequent tests conducted in several national
   control laboratories revealed no undeclared substances in the vaccine.

And the damage done
 At the height of the HLI campaign, TT immunization suffered in all four countries. A
  Manila court injunction (now lifted) banned the use of TT in immunization campaigns
  in the Philippines. TT immunization was also halted in Nicaragua. In Mexico, the
  Secretary of Health was charged with genocide. And from Tanzania came a plea by
  the health ministry for WHO assistance in combating HLI's campaign.


                WHO FACT SHEET: TETANUS TOXOID CONTROVERSY, PHILIPPINES Page 1 of 7
   The EPI believes levels of TT coverage among women in the four countries may well
    have fallen and neonatal lives may well have been lost as a result of the HLI's so-
    called pro-life campaign.

Causes and Consequences of the Tetanus Toxoid Controversy in 1995
(A social science perspective)
This paper presents the findings of a study on the tetanus toxoid controversy that took
place in early 1995 in the Philippines. It reviews the historical development of the
controversy and describes its consequences in terms of coverage of tetanus toxoid
vaccination among women of reproductive age.

Historical background of tetanus toxoid
Tetanus toxoid was first introduced into the national immunization programme in 1979.
During this time, TT was given only to women in pilot provinces. The inclusion of TT in
the immunization programme was implemented nationally in 1980. Under this
programme, pregnant women (particularly those women who are having their first
pregnancy or those who received the TT for the first time) had to have at least two TT
shots before giving birth. The schedule then was to give the first shot anytime during the
second trimester of the pregnancy, and the second would follow one month after. The
third TT would be given three months after the second vaccine. The remaining two doses
would be given at one year interval regardless of whether a woman is pregnant or not.
Completing the five doses of TT provided the woman with a lifetime immunity against
tetanus and it would likewise protect her children in future pregnancies against neonatal
tetanus (NT).

TT was produced and supplied by the Biologicals Production Services (BPS) of the
Department of Health. In 1995, the BPS temporarily ceased producing these vaccines
when its property in Alabang was sold to Filinvest, a private development corporation.
The national government through the DOH intended to build a bigger and more
sophisticated facility for BPS at the University of the Philippines in Los Baños.

The performance of the TT in the country has been slow since its inclusion in the
programme in 1980. A survey of immunization coverage conducted in 1982 showed a
coverage rate of 45%. A significant decline was noted in a 1985 survey because it was
found to be only 18 per cent. However, EPI health service statistics on the same year
showed a performance rate of 55 per cent. This figure was higher than the target set for
TT in 1985 which was only 50 per cent of women in the reproductive age (EPI Review,
1986).

Since 1986, the Department of Health's target for TT increased to 80 per cent of women
in the reproductive age. This goal was similar to the Universal Child Immunization's
(UCI) initiative for fully-immunized children (FIC) which was also 80 per cent. In 1990,
the mid-decade goals of DOH on child survival included elimination of neonatal tetanus.
Elimination of NT is described as NT case of less than 1 per 1,000 live births. The table
below, however, indicates that the coverage for TT2+ since 1987 until 1996 had not
attained the 80 per cent target. It was also noted that performance for this vaccine was
highest on the first year of the NID (1993) at 70 per cent.
                          Philippine TT2+ coverage, 1987–1996
                                 YEAR       TT2+ COVERAGE
                             1987           28.9
                             1988           37.2
                             1989           43.6
                             1990           42.3
                             1991           53.7
                             1992*          16.8
                             1993           70.0


                WHO FACT SHEET: TETANUS TOXOID CONTROVERSY, PHILIPPINES Page 2 of 7
                          1994             69.3
                          1995*            57.5
                          1996             47.0
                                  * partial report only
          (Source: File of the Maternal and Child Health Services, DOH, 1997)

Tetanus toxoid and the NID
In 1993, the Department of Health launched the first National Immunization Day (NID).
The NID was aimed primarily at eradicating poliomyelitis by giving additional doses of
OPV. To maximize the presence of young children and their mothers, other vaccines
were also included. These vaccines were measles vaccine and tetanus toxoid. The NID
was intended to reach the remaining 20 per cent of the country's population who were
not reached by routine immunization. These include women and children in the far-flung
or isolated barangays, the indigenous peoples, urban slum-dwellers and those caught in
armed conflicts.

The coverage rate for TT during the first round of the NID in April 1993 reportedly
reached 86 per cent. The succeeding NIDs showed that TT coverage rates ranged from
20 per cent in round two in 1995 and 74 per cent in round one in 1994.
             NID Coverage for Tetanus Toxoid, Philippines, 1993-1995
                                       TT Coverage
                              First round                          Second round
 Year                   Number              per cent           number        per cent
    1993               1,966,167              86.0            1,512,947        66.0
    1994               5,681,934              74.0           4,460,312*        58.0
    1995               5,035,153              67.0            1,481,689        20.0
    * partial report as of August 1994 only (Source: File of MCHS-DOH, Manila 1997)
The rise in the number of women who received TT was not only shown in the NID but
also in the routine immunization. The 1993 TT coverage of 70 per cent at the health
centers was the highest. However, a decline was noted in 1995 and 1996 following the
controversy surrounding the TT.

The TT controversy
In 1995, the Roman Catholic Church mainly through the Pro-Life Philippines, which is
headed by a nun named Sr. Pilar Verzosa, raised an issue against TT. Pro-Life is a
religious movement which campaigns against abortion and the use of modern
contraceptives.

The controversy started on 7 February 1995, a week prior to the first round of the NID
for that year, when the Department of Health received a copy of an "alert memo" which
was being circulated in Southern Philippines particularly in Cotabato City. The
memorandum claimed that TT could cause abortion. The memorandum was issued by
Simbahayan Commission of the Archdiocese of Manila – Marriage and Family Life
Ministries and it was addressed to the Diocesan Family Life Coordinators (Tagle in BW,
March 20, 1995:P4). It stated that Pro-Life Philippines found that TT contained a sex
hormone called HCG (human chorionic gonadotropin). When introduced into non-
pregnant women, the hormone would induce the production of antibodies that would
attack the HCG normally produced by the woman when she gets pregnant. The
normally-produced HCG is needed to maintain the pregnancy and when this is attacked
by the HCG antibody, it would allegedly result to abortion.

In an interview with Sr. Pilar Verzosa, she mentioned that their group became concerned
about TT immunization in the country after reading reports from Mexico that the TT used
for the immunization programme was contaminated with HCG. Corollary to this, they
also heard reports about the development of an anti-fertility vaccine which was being
tested on women in Sweden and in India. Furthermore, they were concerned when the

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EPI targeted on women of reproductive age in its TT immunization and it did not include
men. She also said that there were reports of adverse effects. This raised their fears that
the TT, particularly those which the DOH imported, would contain anti-HCG.

The DOH started importing TT in 1995 after the BPS stopped its vaccine production
following the purchase of its property in Alabang by Filinvest, a private real estate
development corporation. An excerpt of the interview is presented below:
   The first time that they had Tetanus Toxoid immunization, I thought it was just another
   one of the activity, just like they were giving the iodized salt. It used to be the children
   only. And then, when it got to be women 14-44 years old, there was already a question or
   doubt in my mind. But this was affirmed when we were getting reports from dioceses,
   parishes, people saying, " is there something bigger than that?" Since the DOH is
   connected with family planning, population control, so they wanted to know why only
   women were being given. When the men would line up, they would be told, "we don't have
   supplies for you, only for the women. And secondly, they (women) started complaining of
   infected arms and then miscarriages or premature deliveries or even defective babies.
   These reports started to come in on the third NID. So, on the fourth immunization, we got
   all the more concerned when a Mexican report told us that the TT we have was
   contaminated with beta HCG. So, I started asking around. I read my books and I said,
   "that's great, HCG is actually the hormone a pregnant woman has". So, it should really
   enhance even the pregnancy. And then, I got these WHO reports – the testing were done
   in India, Sweden, Canada – that beta HCG was being put with TT or with diphtheria or with
   cholera immunization as a ride on. And since its beta-HCG, the women develop an
   antibody against the baby. So that, as soon as the baby comes in and its hardly a month
   old, there's something in her blood that shuts it off. And the woman will not produce HCG
   that is needed by the baby to maintain its pregnancy.


In March 1995, barely a week before the second round of NID for that year, different
religious groups went to court and asked for an order to temporarily restraints DOH from
giving TT. These groups were: Council of the Laity in Manila (CLM), Family International
Foundation (FIF) and the Catholic Women's League (CWL). They alleged that the TT that
the DOH utilized for its campaign contained BHCG. The petition was filed before Judge
William Bayhon of Branch 23 of the Manila Regional Trial Court. An excerpt from their
petition (Borlongan, MB March 19, 1995: 11) is as follows.
   The tetanus vaccine being administered to women of child-bearing age has been tested
   positive for human chorionic gonadotropin (HCG) which has no business being part of the
   tetanus toxoid. In a laboratory analysis conducted by the Nuclear Department of the
   Makati Medical Center, it was found to be an abortifacient.


The report from the Makati Medical Center showed very minimal traces of HCG in the TT
(from 1 to 7). The aforementioned religious groups sent TT samples apparently from the
stock of DOH. Samples from the same stock were sent by the DOH to St. Luke's Medical
Center and it showed zero levels of HCG (Today, 31 May 1995:9).

The differences in the result, according to Sr. Pilar, are due to the different testing
methods used by Makati Medical Center and St Luke's Hospital. The Makati Medical
Center group used the nuclear test but the kind of test utilized by St. Luke's Hospital was
not explained. The conflicting test results which were initiated by DOH and Pro-Life
Philippines added to the confusion. A week after the filing of the petition, a group of
international experts as well as scientists from the World Health Organization (WHO)
gave the assurance that the TT used in the EPI was safe.

A neutral body was also asked to test the TT from the DOH. The test was conducted at
the Institute of Sciences in Health in Maryland, U.S.A. According to Dr Veronica Chan,
Dean of College of Public Health in the University of the Philippines-Manila, the test
showed negative or negligible traces of HCG. This, she added, could not cause any harm
on the unborn child or on the woman. (Proceedings of the Symposium on Vaccine
Technology and Production in the Philippines, September 1997).
                 WHO FACT SHEET: TETANUS TOXOID CONTROVERSY, PHILIPPINES Page 4 of 7
Apart from the issue of being an abortifacient, the Pro-Life also questioned the increasing
number of complaints of adverse reactions to TT. In separate interviews with health
providers in the cities and provinces, it appeared that there was actually an increase in
the number of women who complained about various adverse reactions to TT such as
numbness at the injection site, intense pain, and even abscess at the injection site.
However, the government health provider-informants explained that the needles used in
the NID which they suspected of being poor in quality, i.e., there are breaks in the
needle which caused the TT to leak into the subcutaneous tissues. The TT is supposed to
be injected intra-muscularly in the deltoid muscle.

It was also noted that these reactions occurred only when the Philippines started
importing TT. A staff from MCHS-DOH explained that this might be due to the increased
efficacy of the imported vaccines. The increased strength or improved efficacy of the
imported vaccines may have also caused women to be more sensitive or reactive to it.
To defend the TT against the controversy, Dr. Juan Flavier, who was already a senator
then, delivered a privilege speech before the Senate on 9 August 1995 to explain some
facts about TT. He reiterated the safety of the vaccines as certified by the WHO and
UNICEF. He said that if Pro-Life allegations were true, there would have been an
epidemic of abortions in the country.

Despite the DOH's efforts to defend the TT, the petition made by the religious groups
resulted in the issuance of the temporary restraining order (TRO) asking the DOH to
refrain from giving TT to women. As a consequence, there was a dramatic drop in the TT
coverage of the NID in 1995 – from 67 per cent in February to 20 per cent in March. The
TRO was lifted on April 4, 1995 (DOH TT Advisory, 1995).

Women's complaints against TT
The issues about TT have also resulted to filing of complaints by some women against
DOH. In Davao City, a woman alleged that she had an abortion after receiving the shot.
She filed a case against the City Health Office for allegedly causing the abortion with the
injection of TT. This incident was shared by the nurse EPI-coordinator in Davao City.
   There was one case reported in Toril. But I think it was presented to the DOH. She
   complained that she had abortion after TT injection. The case was investigated. The case
   was dismissed in court. Concurrently, we intensified our information campaign – we have
   distributed hand-outs, information with regards TT. The DOH also sent an advisory where
   they placed the answers to all probable questions about TT. So, we cleared the issues in
   the community. The controversy just died down.


A doctor was said to have assisted the woman in making the legal move which they filed
in May 1995. In August, the woman and her husband issued a public apology to the City
Health Office of Davao and retracted their complaint (David, PDI August 16, 1996: p9).
The doctor who helped them file the complaint joined the City Health Office of Davao and
was reportedly assigned to a station in a remote barangay.

In Baguio City, a woman complained that she contracted meningitis after receiving TT.
But it was later found that she was already sick even before receiving the shot. Despite
the false claims, the DOH provided assistance in the form of medicines and subsidy for
the food and incidental expenses while the woman was staying in a government hospital
in the city (Mendoza on Today, March 28, 1995, p.12.).

The aftermath of the TT controversy
While the Roman Catholic Church hierarchy and the DOH were having their battle in
court, a number of many women appeared convinced that TT could cause abortion
following the Catholic hierarchy's public pronouncements against TT. During the focus
group discussions with older mothers and mothers of FIC and partially-immunized
children, the women respondents from high or low-immunization coverage sites were

                 WHO FACT SHEET: TETANUS TOXOID CONTROVERSY, PHILIPPINES Page 5 of 7
inclined to believe that TT could indeed cause abortion. Some of the remarks are as
follows:
A woman reportedly had an abortion after receiving TT,
the pregnancy was on its eighth month when aborted.
I heard that TT can cause abortion.
I heard that TT can cause sterility.
A woman collapsed immediately after receiving TT.
My arm became numb and tired after TT injection.
They are giving TT immunization to control our population, I heard that there were many who had
abortion after receiving the TT. That was the time of Secretary (now Senator) Flavier.

Despite the alleged fears, one respondent from a rural, high performing area said that
she would continue to get TT injections because she was afraid that the health personnel
in their health center would not help her during child birth. She also said that she had to
go to the health center for her prenatal check-up, so she could not really avoid getting
the injection.

Health provider's view about the TT controversy and its effects
During the personal interviews with the health providers in the field, they observed a
declining coverage rate of the TT immunization. The provincial Health Office of one
province reduced its target from the national benchmark of 80 to 60 per cent of women
of reproductive age. Despite the reduction, the PHO claimed that they were still not able
to meet their 60 per cent target. This performance was attributed by the PHO to the
massive anti-TT immunization campaign that was launched by the Roman Catholic
hierarchy. At the regional level, it was estimated that the coverage for TT2+ went down
from 80 per cent to as low as 20-25 per cent. As shown in the FGD results, women from
all over the country have actually heard and probably believed the Roman Catholic
hierarchy's campaign against TT immunization.

One health personnel from a regional health office, however, debunked that the
controversy caused the reduction in the TT coverage. She said, many of the women
must have already completed their TT immunizations of five doses from the NID sessions
that were conducted since 1993.

Also beginning 1995, the DOH issued an order that TT should only be given to pregnant
women during the later period of the second trimester. This was done to avoid getting
blamed in case of abortion. According to a regional nurse EPI coordinator, the health
providers began using a different approach in assessing TT coverage in 1995. By
obtaining the mother's history, the health worker was able to assess if the newborn baby
is protected from neonatal tetanus. If the mother received at least two doses of TT, then
the baby is considered protected from neonatal tetanus. Health workers are now utilizing
this new approach rather than relying on the TT coverage results.
Many health providers believed that the controversy against TT would have a negative
impact on the health of women and children. They have this to say about the TT
controversy.
   Sometimes, people can become unreasonable. We could not even find water in its purest
   state – hydrogen and oxygen only. There would really be some degree of impurities in the
   process of preparation (of the TT). I think there is a degree of paranoia in these groups,
   they exaggerate. They exaggerate their being against the family planning programme.

   Neonatal tetanus – we've got a problem with neonatal tetanus because before the
   controversy with regards to the injection of TT we only had a few cases of neonatal
   tetanus. In fact, this was not one of the ten leading causes of infant mortality anymore.
   Unlike the previous years when it is one of the ten leading causes. I think last year (1996)
   it was already included as a leading cause of morbidity in our region. So, we have to
   emphasize our tetanus toxoid immunization, not only to pregnant women but also to
   women of childbearing age.



                 WHO FACT SHEET: TETANUS TOXOID CONTROVERSY, PHILIPPINES Page 6 of 7
At the height of the TT controversy, the Department of Health issued an advisory to the
health personnel to help them answer questions about TT. The health providers
interviewed revealed that this advisory helped them a lot in explaining the TT to the
people and to the church leaders in their community. At least two health providers said
that they had provided information to the Catholic Church leaders particularly the parish
priests, to help neutralize the controversy.

TT and the measles problem
The impact of the tetanus toxoid controversy was not limited to the uptake of TT, but it
also affected the coverage for measles vaccination. From a peak of 114 per cent in
February 1995, the coverage for measles during the NID dropped to about 30 per cent in
March 1995. As Senator Flavier said, "When mothers do not go for TT immunization,
they also do not bring their children for measles" (personal interview, 1997).

Acknowledgements:
This text is abstracted from: The Social and Cultural Dimension of Immunization
Practices in the Philippines by Pilar Ramos-Jimenez, Cristina A. Rodriguez, Oliver L
Patino, and Maricel B. Lim. Published by Social Development Research Center, College of
Liberla Arts, De La Salle Universtiy, Manila, Philippines, August 1998. The project was
part of the Social Science and Immunization multi-country study coordianted by the
Royal Tropical Institute and the University of Amsterdam.
1
  The coverage exceeded 100 per cent because there may have been some discrepancies
in computing for the target population. The population used may have been lower than
the actual number of children in the communities




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