Norplant Information



Citizens Petition before the Food and Drug Administration
requesting withdrawal for sale of Norplant

The undersigned submits
this petition under the Federal Food, Drug and Cosmetic Act to request
the Commissioner for Food and Drugs to withdraw Norplant’s approval
for sale in the United States.

Action requested

We request the Commissioner of the Food and Drug Administration to
withdraw the approval for sale of Norplant , a contraceptive system
which was initially approved for sale on 10 December 1990 and which is
manufactured by Wyeth-Ayerst.

Statement of grounds

1. Background of Norplant

Norplant consists of six small flexible capsules made of Silastic
tubing and filled with a synthetic progesterone, levonorgestrel. The
capsules are surgically placed subdermally on the inner side of a
woman’s upper arm where they are supposed to remain for five years and
then be removed surgically. Norplant is manufactured by Wyeth-Ayerst,
a division of American Home Products. Population Council holds the
patent for Norplant.

Norplant has been widely used in contraceptive programs around the
world. It is claimed that extensive clinical trials, involving some
55,000 women from 46 countries, have proven both the safety and the
efficacy of Norplant.1

2. Reasons for market withdrawal

There are three principle reasons the Commissioner of the Food and
Drug Administration should withdraw Norplant’s approval for sale in
the United States:

American women have been experiencing adverse health conditions
after beginning to use Norplant that are more serious and sustained
than the side effects cited by Norplant’s manufacturer at the time of
approval.

These possibly Norplant -related conditions have not
occurred only in the United States but are part of a larger and
continuing pattern of adverse health conditio ns for users worldwide
which stretches from relatively wealthy and medically astute American
woman to desperately poor women in nations like Bangladesh, Haiti, and
Brazil. These adverse health conditions pose a serious and as yet
unquantified health risk to American women because, as we document
below, data reflecting the reality of Norplant’s hazards to women were
simply not collected following its introduction into several
countries. It is unclear whether, and to what extent, these facts were
made known to the Commissioner of the Food and Drug Administration
prior to the Norplant’s approval in 1990.

The drug delivery system
known as Norplant, which introduces a constant, low-level of
progesterone into a woman’s body, may diminish their natural
resistance to HIV and other sexually transmitted diseases.

3. Detail of reasons for withdrawal

A.

Adverse health conditions among American women subsequent to
Norplant use American women have experienced serious adverse health
conditions after having Norplant inserted, including, but not limited
to, increased intracranial fluid pressure (pseudo tumor cerebri),
chronic blurred vision, leading to permanent vision loss or blindness,
and tumors in the brain and other organs.2,3 Other conditions
experienced by American women include hyper menorrhea (heavy and
sustained menstrual bleeding), serious acne, sustained nausea,
debilitating headaches, weakness or paralysis in one or more limbs,
endometriosis, ovarian cysts, weight gains of sometimes over 100
pounds, severe mood swings and irritability. Further, many have found
that having Norplant removed was a much more difficult procedure than
they had been originally advised.4

Representative Case histories:

Patsy Smith of Houston, Texas: As documented by the BBC, three
months after having Norplant inserted into her upper arm, Ms. Smith
began to experience increasing degrees of vision impairment compounded
by severe headaches. Concerned, she consulted Dr. Rosa Tang, a noted
neuro-ophthalmologist. Dr. Tang diagnosed Patsy as suffering from
pseudo tumor cerebri, which is a condition of increased intracranial
fluid pressure. This increased pressure had crushed Ms. Smith’s optic
nerves, leading to functional blindness in one eye and serious vision
loss in theother.

Noting that Ms. Smith’s condition had arisen subsequent to her
recent Norplant insertion, Dr. Tang decided to investigate the
possibility of a causal relationship. She wrote to all the other
ophthalmologists in Texas to ask if any of their patients on Norplant
had developed similar symptoms. Over 100 cases were brought to her
attention, including 40 women with some degree of vision impairment
and eight with conditions similar to her patient’s. Dr. Tang described
for the BBC the impact thenumbers had on her concerns about Norplant:

“[The survey result] was very surprising for me because I had not
seen any reports in the literature at this time of such a link between
Norplant and pseudo tumor cerebri and I was surprised of the fact that
there were so many patients that seemed to be having the condition
related to Norplant. I think that there is enough out there that there
is a possibility of a link between the two [and] that a larger-scale
study should be done if Norplant is to be continued.”5

Wanda Candelaria of Chicago, Illinois: Ms. Candelaria had Norplant
inserted in a Chicago hospital in February 1992. She bled on 572 of
the following 630 days, until she refused to further believe her
doctor’s reassurances that her body would eventually “adjust” to
Norplant, and insisted that it be removed from her arm.
During the
removal procedure the sensory nerves in her arm were damaged and she
has lost all sensation in an area extending from the insertion site
down to her elbow. She will likely require additional reparative
surgery.6

Lyne Triezenberg of Elwood, Illinois: Following the Norplant
insertion Ms. Triezenberg experienced vision loss so severe it
requires the use of bifocal glasses even though she is only 24 years
of age.7

Kim Colglazier of Elkert, Indiana: Four days after the insertion of
Norplant in August of 1992, Ms. Colglazier began to experience blurred
vision and within one week had permanently lost all sight in her right
eye. A Cleveland doctor she consulted about her condition diagnosed
her as having had a stroke resulting from the use “birth control.” At
the time the only method of birth control Ms. Colglazier used was
Norplant. 8

Patient A: Four weeks after having Norplant inserted in 1994, a 40
year old woman approached doctors complaining of blurred vision in her
left eye. She reported never having previously used hormonal
contraceptives. Her vision continued to deteriorate over several
months and was increasingly impaired in color and light sensitivity.
Magnetic resonance imaging indicated a homogenous mass crowding the
left optic nerve opening. The tumor mass was surgically removed and
was later found to be a meningothelial neoplasm which tested positive
for progesterone receptors. This and other incidents suggest that
hormones may stimulate meningiomas to grow.9

FDA “Medwatch” Data:

Writing recently in the medical journal Obstetrics and Gynocolgy,
Diane K. Wysowki, PhD, and Lahn Green, Rph, MPH, report that between
February 1991 and December 1993 the FDA received 5800 reports of
adverse health events involving Norplant use through its Medwatch
Reporting System. These events included pseudo tumor cerebri (39
cases), hospitalizations because of infections and difficulties with
removal (24 cases), strokes (15 cases), and thrombocytopenia (6 cases
– 1 death), among others.10

Wysowki and Green, who are employees of the FDA’s Division of
Epidemiology and Surveillance, maintain that it is difficult to track
incidents of adverse reactions to Norplant through the Medwatch system
because reporting is voluntary and depends therefore on a number of
uncontrollable factors.

Even so, they concluded that while “[n]one of the reporting rates
exceeded the expected rates of the disease . . . reporting rates for
stroke and pseudo tumor cerebri (which reflect the under reporting of
an unknown magnitude) were close enough to the expected rates (which
reflect all causes) to suggest that Norplant users may be at an
increased risk of developing these disorders.”11

This public expression of concern by FDA employees over the
possibility of adverse health conditions resulting from Norplant is
remarkable. Given the limitations of the data reviewed by Wysowki and
Green, it is likely that the incidence of pseudo tumor cerebri and
other adverse conditions are far higher than reported. The cases of
Patsy Smith and Patient A reported above, for example, were not
available to these FDA researchers at the time their article was
written.

Evidence from Norplant’s manufacturer, Wyeth-Ayerst:

There is evidence that Wyeth-Ayerst, Norplant’s manufacturer, is
aware of the link between their product and most, if not all, of the
adverse conditions mentioned above. This is strongly suggested by the
fact that on 24 July 1994 Wyeth-Ayerst promulgated a new set of
guidelines for doctors and clinics involved in the insertion of
Norplant. These guidelines list 23 new adverse medical conditions in
connection with Norplant, including pseudo tumor cerebri, stroke, and
arm pain and numbness. Not only were these adverse health conditions
not mentioned to most if not all of the women offered Norplant
insertion prior to 24 July 1994, it is alleged that they have still
not been offered to the hundreds of thousands of women currently
experiencing Norplant and further alleged that physicians or clinics
have not been required to inform perspective Norplant users of the new
information.12

Another indication that the manufacturer is concerned about the
adverse medical conditions associated with Norplant comes in the form
of a report that Wyeth-Ayerst has “quietly undertaken a major medical
inquiry into [Norplant’s ] long term health effects.”10 This report,
which appeared in the Cleveland Plain Dealer on 17 September 1995,
cites “internal documents” at Wyeth-Ayerst which expressed concern
over a “lack of information” about the health consequences of
Norplant, and in particular about its effect on young women ages
13-20.

The newspaper further reported that Wyeth-Ayerst in 1992 hired
Trudy Bush, a researcher at the University of Maryland School of
Medicine, to design a study to test the effect of Norplant on young
women. Ms. Bush is quoted in the story as saying that “The data the
company had [at the time of FDA approval] was for women in their 20’s
and 30’s, whereas Norplant was being used by adolescent women a lot.
We just don’t know what giving a 15-year-old five years of
progesterone will do.”

The Cleveland Plain Dealer also quotes Lisa Rarick, whom it
identifies as the FDA official who recommended approving Norplant in
1990, as having urged Wyeth-Ayerst to do more studies which included
“adverse events” on American women since “the original trials mainly
involved women older than 18 in some of the poorest countries.”

Rarick also recalled being concerned over “differences in reporting
of side effects” between women in the developing world and those in
the United States. Based on information which we have collected and
document in the next section, we believe those concerns are amply
justified.

B. Adverse conditions in United States linked to adverse conditions in developing world

The adverse medical conditions experienced by American women are
part of a worldwide pattern. Women in Bangladesh, Haiti and Brazil
have all reported problems with Norplant similar to those suffered by
American women, most often while taking part in allegedly “clinical”
trials for this drug delivery system. There is evidence which suggests
that the organizations responsible for administering Norplant “trials”
in the developing world (and collecting data from those “trials”) did
not inform women as to Norplant’s experimental nature, ignored women’s
problems with the contraceptive and failed to remove the capsules even
when asked repeatedly to do so. Disturbingly, these results of the
“trials” were later represented as “successful” and as an indication
of how well women around the world had accepted Norplant.

B 1. Norplant in Bangladesh.

The first attempt to market Norplant to Bangladeshi women came in
1981. Advertisements were placed in Bengali-language newspapers
entitled: “A new birth control method /NORPLANT/ a wonderful
innovation of modern science.” The advertisement went on to say that
Norplant was for women, can be implanted under the skin of the arm,
will “ensure sterility” for five years and that its effects are
reversible when removed. Nothing in the advertisement mentioned
anything about the product’s experimental nature, possible adverse
health conditions associated with the product, or other concerns.

Alerted to Norplant’s experimental nature, women’s groups in
Bangladesh protested its use.13 Over 150 concerned doctors,
pharmacists and health workers petitioned the Minister for Health to
stop the trial, which was subsequently “postponed.”14

In 1985 Norplant returned to Bangladesh again, this time in the
context of an explicit “clinical trial,” “to assess the acceptability
and effectiveness of this new method among Bangladeshi women” and”to
decide about the use of Norplant on a large scale in the family
planning programme.” Nothing was said in 1985 about the “trial” doing
anything to measure safety or adverse conditions from Norplant use.15

The 1985 “trial” was conducted in secret, without the public
announcements and advertising campaigns that had alerted Bangladeshi
women groups four years prior. The details of the “trial,”
particularly the negative impact it had on the very poor women who
were recruited to take part, would remain unknown today had it not
been for the efforts of a handful of social workers. Faced with almost
a total lack of cooperation and candor from the organizations
conducting the “trial” in Bangladesh, they went themselves into slum
areas and villages and located women who had been inserted with the
“five year needle,” as it was called in Bengali.

These social workers were able to obtain an informational handout
which was given to women who were considering Norplant. The handout
represented that Norplant is a 100 percent effective contraceptive for
five years; that it is “relatively easier” than other methods; that
its side-effects are “less than that of the pill;” that the user can
take out the Norplant whenever she wants; that after taking out
Norplant fertility returns in one year; that it is possible to carry
out normal movements and work when it is in the body; and that there
is no need to use any other method with Norplant. 16

The FDA regulation governing the evaluation of foreign clinical
studies states that such studies will be accepted provided “they are
well designed, well conducted, performed by qualified investigators,
and conducted in accordance with ethical principles acceptable to the
world community.” The regulation then cites verbatim the Helsinki
Declaration on Biomedical Research. The workers who discovered the
trial were aware of the acceptable international norms for such
research and carefully interviewed women who had been given Norplant
about their experience. The following are some of the discrepancies
between what the international norms declare should have occurred and
what actually happened in Bangladesh.

International norms

Practice among women contacted

Acceptors of the method under investigation should be informed that
it is on trial and that they are subjects of biomedical research. vs.
None of the women interviewed knew that Norplant was still on trial.
The only information given to them was that “it is one of the
contraceptive methods and lasts for five years.”

Research subjects must be throughly informed about known and
possible side-effects. vs. Only a few of the women interviewed were
told that there would be some “disturbance” in their menstrual cycles,
but these were told “there would be no more problem.”

After providing all information pertinent to the research project,
consent from theresearch subjects must be obtained. vs. The social
workers could not find information which showed any sign of seeking
informed consent from the women who are about to have the Norplant
capsules inserted.

A medical examination and screening of the research subjects should
be conducted before they enter the trial. vs. Only cursory medical
exams, weight and blood pressure checks, were offered to most
women.

Medical support should be given to researchsubjects once they enter
the trial. vs. Medical support ranged from vitamins to pain killers to
“unidentified prescriptions on plain white paper” to nothing at
all.

Source: Ubinig “Norplant, the five year needle: an
investigation of the Norplant trial in Bangladesh from the user’s
perspective,” Issues in Reproductive and Genetic Engineering, 1990
3(3):223-224.

B 2. Bangladeshi women in their own words

Despite assurances that the side effects of Norplant would be “less
than the pill,” a significant number of Bangladeshi women began to
experience severe adverse effects subsequent to insertion. In
interviews with BBC, here is how some of them described their
condition:17

“Suddenly [after having Norplant inserted] my body became weak,
quite suddenly. I couldn’t get up, couldn’t take care of my children,
couldn’t cook. I was bedridden”

“[m]y limbs felt like collapsing, as if they were being wrenched
apart. I couldn’t work or eat even. I had to lie in bed for 3 months.
I couldn’t do anything … I was bleeding all the time.”

“In 6 months [I went to the clinic] about 12 times. Yes, about 12
times. I went to the clinic and pleaded I’m having so many problems.
I’m confined to bed most of the time. Please remove it [Norplant ]’ My
health broke down completely. I was reduced to skin and bone. I had
milk and eggs when I could, but that did me no good.”

“I felt so bad, my body felt so weak, even my husband told me it
was all very inconvenient … [My husband] says he’ll get another wife
tomorrow. I told the doctors, Please take it out, I’m having so many
problems … I felt like throwing myself under the wheels of a
car.”

“I couldn’t see. I couldn’t look at things at a distance. I had
trouble focusing. You know in the village we light oil lamps. I
couldn’t look at them. They looked like the sun, as red and large as
the sun. If I looked into the distance, my eyes would water … If I
went out of doors, my eyes became absolutely dark. I couldn’t see
anything at all as if my eyes had become affected by blindness.”

B 3. Difficulties with removal

The difficulty that Bangladesh women experienced in having Norplant
despite earlier assurances that “users can remove Norplant whenever
they want,” is worthy of separate comment. Many women found that they
were expected to carry Norplant to term no matter what adverse medical
conditions they developed. In interviews with the BBC, here is how
some of the women and representatives of women’s groups described
their situation:18

“I went to the clinic as often as twice a week. But [the clinic
workers] said, This thing we put in you costs 5000 takas. We’ll not
remove it unless you pay this money.’ Of course I feel very angry. I
went to several other doctors and offered them money to take those
things out, but they all refused. I went to three or four of them and
they said that these can only be taken out by those who put them in.
They said that, if they tried they might go to jail.” [italics
added].

Farida Ahktar, a Bangladeshi woman’s rights activist, recounts
that: “One woman when she begged to remove it, said I’m dying, please
help me get it out’. They said OK, when you die you inform us, we’ll
get it out of your dead body’, so this is the way they were treated.
In a slum area people are living in a very small [area], like 5ft by
7ft where at least five family members are living and these woman are
working outside. The most important resource they have is their own
healthy condition.”

“We have … information where these women have told us that they
have sold their cow or the goat which was the only asset they had for
treatment because she had to get well, otherwise the family can’t
survive, so in order to save her, they had to, you know, sell the cow
or if they didn’t want to treat her then she suffered, so the family
was suffering either way. In every sense these people were totally
torn. Their economic condition were torn, their family happiness was
totally gone.”

When the Norplant trial ended in 1993, the organizations involved
announced that “Norplant is a highly effective, safe and acceptable
method among Bangladeshi women.” They claimed that less than 3%
reported significant medical problems.19 The report did not mention
women being denied removal of the implants or the problems with
adverse conditions. Dr. Nasreen Huq, a physician and consultant to the
government of Bangladesh on women’s health issues, subsequently
criticized the trial:

“I think the Norplant trials were bad science, really shoddy
science, because they were not recording the side-effects. They were
scolding women when they wanted to report side-effects, they were
scolding women if they came in at a time when they were not scheduled
to come in for a follow-up check. Their request for removal were
disregarded, were not even recorded during the trial. So how can they
tell us that it was an acceptable method for women and that this has
been scientifically tested out, you know? When continuation rates
reflect caution, reflect refusal to remove, reflect disregard of
women’s concerns, reflect disregard for women’s health, how can they
even accept that this has been the work of scientists?

“When you conduct a trial in this sort of setting, you are simply
taking advantage of them being poor. You’ve access, cheap access, to
subjects, and you can write it up as a successful trial. You’re not in
any way advancing science, you’re taking advantage of a situation in
which women are poor and they don’t want to have more children, and by
providing this method, or conducting this trial, you are not in any
way letting them out of their desperate situation. I mean, I have been
trained in science and I’m sorry, this is not science.”20

C. Norplant in Haiti

A Norplant trial in Haiti is also alleged to have been conducted in
a less than ethical manner. Medical Anthropologist Catherine
Maternowska, who was sent to Haiti on a Population Council fellowship,
witnessed serious abuses in the trial:21

“Side effects in the context of Haitian women’s lives are horrible.
With the Norplant users they were extremely sever. Bleeding could go
on for 18 months … Another bad side-effect was headaches … many
women collapsed from this method under sheer exhaustion. They could
not work so ill, theywere unable to function. Ms. Maternowska also
reported that Haitian women had difficulty having the implant
removed:

“One woman came in with an infection in her arm. She was a market
woman, she carried heavy loads on her head and when she came in asking
to get the insert out, the doctor complained and he complained and he
looked at me and he was used to having me in the clinic and he said,
Oh Cathy, look at this woman, she’s an animal, she wants her Norplant
out, she’s an animal. She has to be in the study and she wants it out
now. What’s her problem?’

“They proceeded to throw her li terally onto the table, lie her
down so that they could … take the N orplant insertion out. They
threw her head to the [side like] this and they gave her the
anaesthesia but before the anaesthesia had actually taken effect in
her skin they started pulling the inserts out and making incisions and
pulling the inserts out. Because [of] the infection in her arm it
looked painful, it was red, it was swollen, and the muscle and sinew
tissue had grown over the implants, they were pulling and she was
wailing, she was crying why, why,’ and they continued calling her an
animal. “I think it’s a sham, it’s disgusting, it appalled me that
this kind of research was going on. When someone’s looking for help,
looking for a solution to their poverty and what they find is
something that just makes their poverty worse, it’s a huge, huge
sadness.”

C 1. Norplant in Brazil

Lack of informed consent was also a problem in the Brazilian
Norplant trial where, in contravention of international standards
governing informed consent, only minimal information was offered about
possible adverse medical conditions:

“The scarce in formation as to possible harm caused by Norplant is
clear in paragraphs 4 and 5 [of the term of responsibility form]: I
understand that the Norplant implants are in general well tolerated
but it is probable that I [will experience] significant alterations in
my menstrual cycle, which include irregularity, intermenstrual
bleeding or even periods of no menstruation at all. It is possible
that other side effects may also occur, such as headaches, weight
gain, acne and other symptoms related to the use of hormones.”22

At the same time, an attempt seems to have been made to have the
patients take full responsibility for any adverse medical conditions
which they did experience:

“…[i]nstead of signing a document legally declaring knowledge of
risk, internationally known as informed consent, the women were given
a term of responsibility’ in the attempt to pass onto them the onus of
possible harm caused by Norplant. “23

Adverse conditions which appeared after Norplant insertion were
severe and often ignored

“According to the study done by Koifman and colleagues, the women
in Rio de Janeiro showed dramatic’ changes in weight. One woman gained
38 kg in 9 months … Another had immediate weight gain of 2 kg in the
first week, 3 kg in the second and also developed depression and
respiratory problems.”24

” Menstrual irregularities’ are treated in the same way. Behind the
term increased bleeding’ are hidden blood losses that would be
considered pathological if the classic gynecol ogical terms and
concepts, such as menorrhea and hypermenorrhea were used. Interviews
with Norplant users … indicate that many women had continuous
bleeding lasting more than 20 or even 30 days. The impacts of these
irregularities’ on these women’s day-to-day lives are ignored.”25

D. Progesterones similar to levonorgestrel may be linked to
increased risk for HIV

On 6 May 1996 the National Institutes of Health announced the
results of a study conducted at the Aaron Diamond AIDS Research
Center. In the study researchers placed progesterone pellets under the
skins of 18 rhesus monkeys and placebos under the skins of 10 others.
Large doses of simian immune deficiency virus (SIV) were then injected
into the vaginas of all the monkeys. Of the 18 monkeys with
progesterone implants, 14 were infected with SIV. Of the ten monkeys
with the placebo, only one was.26

This study suggests that progesterone and similar hormones, when
left at a consistently high level for a long enough period of time,
may so thin vaginal walls that they reduce the vagina’s ability to act
as a barrier to HIV and other sexually transmitted diseases. The
hormone delivery system which exposes vaginal tissue to significant
levels of hormones for the longest period of time is Norplant.

Contraceptive manufacturers and agencies of both Federal and local
government have urged women using hormone-based contraception to also
use barrier methods, such as condoms, for additional protection.
However, given that one recent study found the condom failure rates
around the world ranged as high as 13.3%27 it seems wise to consider
withdrawing from use a drug delivery system which may place women at
great risk of contracting HIV.

4. Conclusions

Significant numbers of American women have experienced adverse
medical conditions after having Norplant inserted. Some women have
become permanently disabled, notably those who have suffered serious
vision loss, suffered extensive scarring, or have partially lost the
use of the arm in which Norplant was inserted. A drug delivery device
which, in even a small percentage of cases, cause permanent disability
which is not correctable by its removal must be viewed with
considerable scepticism.

These adverse medical conditions have been experienced by women
abroad as well, sometimes, as we have documented, in the context of
Norplant trials which were conducted under unethical, dishonest and
inappropriate conditions. These trials make it clear that a
significant number of women experienced side effects which went beyond
those cited in the Norplant literature, including hyper menorrhea,
debilitating headaches, bodily weakness, vision problems, and other
troubling conditions. The under reporting of adverse medical
conditions from these trials is particularly troubling, as it suggest
that the trial sponsors were more concerned about Norplant’s speedy
introduction or approval than the health and safety of current or
future users.

There are other troubling aspects to Norplant’s history. It has
been reported that FDA officials, subsequent to approving Norplant,
urged the manufacturer to further investigate its long-term effects.
Given that Norplant is little more than a long-term drug delivery
system, this advice strikes the outside observer as somewhat odd.
Surely all questions about the medical wisdom of prescribing a
multi-year drug regimen should have been answered prior to approval.
Furthermore, two years after Norplant’s approval, the manufacturer
updated its own product guidelines to include a greatly expanded list
of adverse medical conditions.

Add to these concerns the recent simian study linking progesterone
to the thinning of vaginal walls with the consequential increased risk
of infection with HIV.

In our opinion, based on the information presented above, we believe that Norplant is a flawed drug delivery system which has:


  • An unacceptably high risk/benefit ratio, especially as compared to other progesterone- related drug delivery systems

  • The potential for causing serious disability

  • An unacceptably wide range of post-usage adverse health conditions

  • An unknown long-term health risk

  • A possible link with increased HIV risk

We respectfully request the U.S. Food and Drug Administration to
disapprove Norplant for sale in the United States.

Environmental impact

We claim categorical exclusion under 21 CFR Sec. 25.24.

Contrary information

On the American section the biggest element of contrary information
is the lack of information. FDA officials cited in the article in
Obstetrics and Gynecology, as well as in the Cleveland Plain Dealer
indicate that the question of cause and effect with Norplant and these
adverse health conditions is still, officially, up in the air.

On the question of the foreign trials there are some studies which
contradict some of the studies presented here. Although even these do
not contradict all of the information. Akhter et. al declare that a
study including follow ups with Bangladeshi women at 1, 3 and 6 months
indicated that roughly 59% of Bangladeshi women in the study
discontinued using Norplant before the study ended. Of those, 75%
requested removal for menstrual problems. 45.3% of those cited heavy
bleeding as the reason for their withdrawal. The study cites only a
small number 2.2% of other side effects.28

Some of the concerns about the trials in Brazil were addressed by
Anibal Faundes of the Population Council in Brazil. Faundes states
that there need to be a differentiation between a “pre-introductory”
study and a “clinical trial.” Because Norplant had already been
approved in Finland and clinical trials conducted in other places
“there was no need,” Fuandes says, for Brazilian women to have more
extensive medical examinations before starting Norplant. Further, the
terms or responsibility form outlined the major side-effects from
Norplant and should be considered enough for informed consent.29

Irving Sivan, Senior Scientist for The Population Council’s Center
for Biomedical Research took issue with some of the numbers offered by
the two FDA staff members in Obstetrics and Gynecology.30 Sivans
states that they have underestimated the total of woman-years of
Norplant use in the United States and thus found a higher than
appropriate ratio for the adverse conditions. The authors respond
however that, even if this were true, the more important number is
likely theunderreporting of cases and on this point we agree.

Certification

The undersigned certifies, to our best knowledge and belief, that
this petition includes allinformation and views on which this petition
relies, and that it includes representative data and information known
to us which are unfavorable to the petition.

Steven W. Mosher, David C. Morrison

Executive Director, Associate Editor


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