The Canadian Coalition on Depo-Provera
c/o Women's Health Clinic
3rd floor 419 Graham Ave
Winnipeg, Manitoba
R3C O3M
December 6, 1991
The Honorable Benoit Bouchard
National Minister of Health and Welfare
House of Commons
Ottawa, Ontario K1A 0A6
Faxed to: 613 952:7746
Dear Sir:
We are writing you to express our extreme concern about the possible impending
approval of depot-medroxyprogesterone acetate (Depo-Provera) as an injectable
contraceptive.
The Canadian Coalition on Depo-Provera, comprised of a broad range of women's,
community, health, professional, consumer and development organizations,
as well as many individuals across Canada, have made repeated submissions
to the Health Protection Branch expressing concern about this highly controversial
drug and requesting a more public process of evaluating the drug. For example,
the Association for Community Living and the Canadian Nurses Association
have statements to this regard. This call was also supported by many politicians
from all parties, including a past Manitoba Minister of Health.
In 1988, The Honorable Jake Epp, then-National Minister of Health and Welfare,
announced that Upjohn, the manufacturer of Depo-Provera, had not demonstrated
long-term safety of the drug for contraceptive use and that Depo-Provera
was not approved for contraceptive use in Canada. We are unsure if this correspondence,
particularly dating between 1985 and 1988, is available to you, and would
be happy to provide copies.
The issues of concern central to this debate remain. Indeed, there has
been further documentation of the need for caution. Studies from New Zealand
raise the concern of increased breast cancer rates in Depo-Provera users
under the age of 25. Studies from the World Health Organization, drawing
from data in Thailand, Kenya and Mexico, also suggest risk among women under
35 years who have used Depo-Provera for shorter periods of time. Data from
Costa Rica stress the need for further research before decisions are made
about contraceptive use.
This is extremely alarming given that breast cancer rates in these countries
are significantly lower than the 1 in 10 risk Canadian women are currently
experiencing.
We are also concerned about recent research which shows a decrease in bone
density in Depo-Provera users thereby increasing their risk factor for osteoporosis,
a disease which is a significant health problem for Canadian women. Other
possible health risks, for example to women with diabetes, have not been
studied.
Therefore, we believe it is absolutely crucial that long term safety in
regard to health risks as they exist for Canadian women be addressed before
this drug is considered for approval as a contraceptive.
Although the controversy has focused on questions of long term safety,
other issues remain. The drug has significant side-effects, such as irregular
periods, amennorhea, weight gain, decreased libido and depression. Many women
stop using the drug due to side effects that are troubling and debilitating.
In addition, it takes over 6 months for the drug to be excreted.
As an injectable contraceptive, Depo-Provera gives women less control over
its use. As a result, society must be particularly vigilant that patients'
rights are protected, and that informed consent procedures are in place
and monitored. Drugs approved for use by the Health Protection Branch may
be prescribed by physicians for any use they deem fit. There is currently
no requirement that their patient be informed that the drug they are receiving
has not been approved for that particular use.
The evaluation of drugs used to treat disease requires a balance between
the effects and side effects of the drug, and the disease's effects and sequelae.
This case has been eloquently argued by the various People With AIDS coalitions.
But a drug used as a preventative intervention with well populations
must have significantly more stringent criteria for safety.
Depo-Provera has been approved for use in Canada in the treatment of endometriosis
and selected cancers. Therefore, it is available in special need medical
situations. But it is also currently being prescribed to teenagers, the physically
and mentally disabled, immigrant, Native and Inuit women without their informed
consent. All too often, Depo-Provera is prescribed to treat social problems
in these situations rather than medical ones. This raises many ethical and
legal concerns. It is important to note that this drug does not protect from
STDs or AIDS, therefore still requiring a discussion between the client and
her physician about motivation, self-esteem and assertiveness.
It is crucial that a mandatory reporting system be created when physicians
prescribe this drug as a contraceptive. This would ensure the ability to
do follow-up should women need to be contacted for screening at some later
date.
To summarize:
1. Depo-Provera should not be approved for use as a contraceptive at the
present time.
2. Strict protocols should be followed when prescribing drugs for unapproved
uses. These protocols should include:
informing the client of the drug's status and the concerns about long term
safety and obtaining a written release. This is essential to a legal and
ethical informed consent being obtained. These releases should be used as
a basis for a mandatory reporting system which would track the drug's use
and allow for follow-up if necessary. In regard to Depo-Provera, this system
needs to created immediately.
3. Research dollars should be allotted to the study of the medical, ethical
and legal issues we have posed here.
4. The drug approval process should be a much more public one. In the case
of long acting contraceptive technologies, such as Depo-Provera, the discussion
cannot be solely a medical one. The complexities of the social and ethical
issues needing discussion is reflected in the broad mandate now pursued
by the Royal Commission on New Reproductive Technologies. Indeed, we suggest
that many of the issues being addressed by that Commission have relevance
to Depo-Provera and should be reviewed.
We urge the government to stand by their decision of 1988, and to remain
committed to protecting the health and safety of Canadian women.
We would appreciate a response immediately. In response to the numerous
requests that we have been receiving for information about the status of
this drug, we will be making these issues public shortly.
Thank-you for your consideration in this matter.
Sincerely,
Madeline Boscoe, R.N. Sari Tudiver, PhD.
Canadian Coalition on Depo-Provera
