While we greatly respect Barbara Seaman's other work, she is wrong
in her assessment of Norplant ("Under
My Skin," January 8). Her article is factually inaccurate, and
her attacks on the Population Council are unfair and unwarranted.
The Population Council has long been an advocate of voluntary choice
of contraception, of balanced and complete information to patients
and providers, of ethical conduct of clinical trials, and of women's
reproductive health and rights.
Seaman should investigate the role of lawyers and journalists in
the "demise" of a safe, effective, long-acting contraceptive. With
a drumbeat of negative media over several years, it is no wonder
that many women think using the implant "would be bad for them."
Although many women have been involved in Norplant-related lawsuits
in the United States, not one class action lawsuit was ever certified,
and not one plaintiff has ever won her case.
Seaman contends that women were not told of possible side effects.
This was one of the issues addressed in the lawsuits in the United
States: In all cases, the court found that the distributor had adequately
informed physicians about the method; it is the physician's responsibility
to inform the patient.
In listing numerous possible side effects, Seaman also failed to
note that these are side effects common to all hormonal methods,
including the birth control pill. Without question, those women
who have troubling bleeding problems should choose to have their
implants removed, and the removals should be performed by competent
and trained providers. Those women who find Norplant use acceptable
should be able to obtain it and have removal on demand. Indeed,
satisfied Norplant users around the world are now using their second
set of implants.
Much is known about Norplant. At least 120 articles about efficacy,
side effects and acceptability have been published. Seaman's allegations
about the risk of ectopic pregnancy and the numbers of women who
have had difficult removals are exaggerations; the article also
ignores evidence about the safety of Norplant to infants of mothers
who began breastfeeding six weeks after childbirth.
The article confuses clinical trials, over which sponsors have
great control, with use following regulatory approval, over which
sponsors have little control. It blames the contraceptive method
instead of judges and legislators who ordered the implants used
coercively in the United States. It condemns the FDA for not requiring
patient informed consent forms until recently, although Norplant
has had such an informed consent since 1995.
The Population Council
encourages the use of modern contraception by women and men in the
exercise of free choice to regulate their own fertility. Adoption
of contraception should always be a voluntary, informed choice,
with the individual making the decision whether to use contraception,
which method to use, when to use it, and when to stop or try another.
While Norplant is not for all women, we at the Population Council
believe in expanding all women's contraceptive options, not restricting
Suellen Miller and Sandra Waldman
The Population Council
Barbara Seaman replies: I stand by everything I said.
I urge the Population Council to reconsider its policy of blaming
outside elements ("the feminists" ... "the media" ... "the lawyers"
... "the judges and legislators") when women turn away from flawed
birth control technologies. Full disclosure is the only way to go.
Women expect it now. And please ask Population Council scientist
and Norplant developer Sheldon Segal and his cronies to stop belittling
the women's health movement. It's almost 30 years since Segal attacked
me in his Family Planning Perspectives cover story "Is Contraception
a Male Chauvinist Plot?"
It's hard to take you seriously as a scientific organization when
you persist in putting your own defensive "spin" on your mistakes.
For example, a blue-ribbon study by the Columbia University School
of Public Health ("Determinants of Early Implant Discontinuation
Among Low-Income Women," Family Planning Perspectives, November/December
Our findings indicate that the impact of exposure
to negative media coverage was relatively modest. ... Another key
finding is that negative experiences associated with the implant
clearly play a role in a woman's decision to discontinue method
use. ... The most frequently cited main reasons for removal of the
implant were menstrual side effects (28%) and headaches (19%), findings
consistent with previous research. Approximately 10% of respondents
cited arm discomfort or infection and another 9% cited weight changes
(primarily weight gain) as their main reason for early removal.
Seven percent attributed discontinuation to mood changes, while
5% mentioned either hair loss, chest pains or negative media reports
as their main reason for removal.
Regarding factual inaccuracies, it's you, not me, who perpetuate
them, sometimes recklessly. For example, we know that hormone residues
are found in the breast milk of Norplant users, but we have no idea
what the long-range effects on the adult reproductive system of
the nursing infant might turn out to be. It's too soon to tell.
What's more, nursing mothers are unlikely to conceive, so why stick
them with a hormonal contraceptive? History may well look back on
this as a naive, ill-advised and shameful experiment, echoing the
use of diethylstilbestrol (DES) in pregnant women during the postwar
era, whose children's reproductive abnormalities--including cancer--were
not uncovered for 25 years.
You say that I "blame the contraceptive method instead of judges
and legislators who ordered the implants used coercively in the
United States." To the contrary, my article acknowledges that: "In
the United States, some judges, prison officials and state legislators
have tried to mandate Norplant for women convicted of child abuse,
as well as for poor women receiving welfare."
Fortunately, nearly all such attempts have been rebuffed or overturned
by cooler heads in our democratic society. The area where Norplant
users do perceive coercion is at the family planning clinic level.
Out of 687 low-income Norplant users interviewed in New York, Texas
and Pittsburgh over a two-year period, 40 percent anticipated or
experienced that "cost barriers" could get in the way of having
Norplant removed. The authors of that study, led by Drs. Debra Kalmuss
and Andrew Davidson at the
Center for Population and Family Health at Columbia University,
urge that "family planning clinics need to make clear that they
follow a policy of Norplant removal on demand, regardless of the
patient's ability to pay."
In support of his beliefs, Davidson helps administer the Norplant
Foundation Supply and Removal Program, which receives a couple
of thousand phone calls a month. Most want removals.