IPPF and Depo-Provera: what about informed consent?

When we inject harmful drugs into the arms of poor women in Afghanistan, Bangladesh, Mali, Sudan, and Tanzania, do we tell them of the drug's serious side effects?

I'm talking about the contraceptive Depo-Provera. (revealed through an access to information request to DFATD on the $6 million funding to IPPF for the Maternal, Newborn, and Child Health initiative)

IPPF (through DFATD) purchased 18,000 units of this drug in one year (2013-2014), and injected over a half million shots of it into these women since 2012. (1)

So what are the drug's side effects?

Depo-Provera doubles the risk of breast cancer in women (2), causes severe bone loss forcing Pfizer to put a black box warning (3) on the drug. The drug also has horrible side effects for women coming off the drug, as reported by women themselves. (4)

Are we telling them of these risks? What about informed consent (5)? Laura Shea of the Women's Health Network wrote a 22 page paper on this drug. She discusses Bone Density loss, and the other side effects. She also comments on its use in developing countries.

"Many women’s groups have opposed the use of injectable contraceptives like Depo Provera in developing countries because Depo Provera poses particular health concerns for poor women, who may have low bone density due to poor nutritional status. These women are already vulnerable because access to local health care facilities is often inadequate or non-existent, and the right to informed consent is often overlooked..."

And just last month we learned that Depo-Provera is linked to a 40% higher risk of HIV.

So what is Canada doing about this? We team up with the Bill and Melinda Gates Foundation, who also provides Depo-Provera to poor countries. (7)

One of the mantras repeated over and over again throughout the hundreds of pages of documentation I've received from DFATD on the IPPF funding, is how IPPF is helping "remote, under-served, poor, and vulnerable populations" in these countries.

Really?

Does IPPF inform these women of the very serious side effects of these drugs? Do they explain the risks in the women's own language? Do these women benefit in any way from informed consent?

I couldn't find any references in the mountain of documentation I received, that referred to informed consent in any way. Yet IPPF tells us they are helping "remote, under-served, poor, and vulnerable populations". With Canadian money.

(1)  

(2) A study of Depo-Provera

"found that for women between 20 to 44 Years of Age, continued use for 12 months or longer was associated with a 2.2-fold [95% confidence interval (CI), 1.2–4.2] increased risk of invasive breast cancer."

(3) Pfizer's black box warning:

"Women who use Depo-Provera Contraceptive Injection may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible. It is unknown if use of Depo-Provera Contraceptive Injection during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk of osteoporotic fracture in later life. Depo-Provera Contraceptive Injection should be used as a long-term birth control method (eg, longer than 2 years) only if other birth control methods are inadequate (see WARNINGS)."

(4) Coming off Depo-Provera can be a woman’s worst nightmare April 4th, 2012 by Laura Wershler

Side effects as reported by women themselves (682 comments)

Depo-Provera: Does this Contraceptive Choice Support the Health and Well-Being of

Adolescents and Young Women? (From a paper written by Laura Wershler for Canadian Woman Studies in 2005)

"One acknowledged outcome of Depo-Provera use is the time delay (three to 18 months or longer) after the last shot for a full return to fertility. This recovery time can be, for some women, fraught with distressing health problems for which no apparent treatment protocol exists. Weight gain is extremely common and more extreme in teenagers than adult women. Many women discontinue the drug for this reason. The depressive effects of DepoProvera are well known. Severe depression, anxiety, and paranoia have all been reported. Some women experience symptoms while on it, others experience depression after stopping the drug. Hot flashes, vaginal dryness, and other menopausal symptoms experienced by some women are directly due to the "bottomed-out levels of estrogen and testosterone" (Rako 1 10) that are also responsible for loss of bone density. Loss of desire for sex and loss of sexual sensitivity are also subsequent to hormonal depletion. Herein lays the irony of DepoProvera use by young women. The drug induces the hormonal profile of a menopausal woman and with it the potential to experience the full constellation of symptoms (once thought to be all in women's heads) that can so diminish the quality of life for women in mid-life and beyond. As a contraceptive choice for teenagers and young women, DepoProvera provides them the opportunity to experience loss of libido, vaginal dryness, unmanageable weight gain, depression, bone loss and other unpleasant outcomes in exchange for pregnancy prevention. These negative side-effects cause many women to stop using the drug, but others tolerate them, often not aware their symptoms are related to their choice of contraceptive. The other irony? Women who tolerate Depo-Provera best are most likely to take it long-term and, therefore, are most at risk for significant and potentially irreversible bone loss... "

(5) Reflections on Depo Provera: Contributions to Improving Drug Regulation in Canada 

"International use as a population control measure 

Historically, family planning programmes typically limited contraceptive choice to those methods that resulted in either: 1) permanent sterilization, or; 2) temporary sterilization as in the case of Depo Provera. Even before its approval as a contraceptive, Depo Provera was promoted by family planning programmes and population control agencies, predominantly in the so-called “developing” countries, because it was identified as a highly effective, provider-controlled technology that promised to drive down birth rates among poor women. Many women’s groups have opposed the use of injectable contraceptives like Depo Provera in developing countries because Depo Provera poses particular health concerns for poor women, who may have low bone density due to poor nutritional status. These women are already vulnerable because access to local health care facilities is often inadequate or non-existent, and the right to informed consent is often overlooked..." (emphasis mine)

(6) Depo-Provera Linked to Higher HIV Risk Researchers Find 

"Depo-Provera is associated with an increased risk of HIV infection in women, according to a review of research in Africa.

Women who receive the so-called “birth control shot” have about 40 percent higher odds of becoming infected with HIV, compared to women using some other form of birth control or no birth control at all, researchers reported."

(7) The Globe speaks to Stephen Harper and Melinda Gates about maternal and child health

"...And Mr. Harper, do you see that the same way, that reproductive health needs to be a part of the initiative? 

[Stephen Harper] Yes, there’s actually a myth that we don’t fund any family planning or maternal health. That’s not true. We do. We, specifically as a result of a vote in Parliament do not fund abortion services but we fund other forms. And yes, I do happen to believe that’s an essential part of the continuum."

Jadelle not purchased for Tanzania - instead purchased for Mali

Remember Jadelle? Well it's back.

I recently received more information from CIDA/DFATD about the $6 million funding to IPPF.

In my current ATIP, it looks like my writing about Jadelle before (see page 181 below) triggered some questions from DFATD to IPPF, about Jadelle.

DFATD asked IPPF:

"Could you please provide us with more information on the contraceptives that your Tanzanian member uses as part of the project we fund?

The response (in part) from IPPF was that:

1. IPPF has not purchased Jadelle and distributed it to Tanzania
2. UMATI has not purchased Jadelle with Canadian funds
3. Canadian funds have not been used to ensure service providers and insert and remove Jadelle [sic] (see page 178 below)

Interesting. But what is even more interesting is that on another page located withing the semi-annual report, I discovered that Jadelle was purchased and used in Mali.

In the IPPF semi-annual report (April-September 2013) it was revealed that IPPF purchased a quantity of 4,000 Jadelle implants for Mali. On the same report, sure enough there is no Jadelle listed for Tanzania. (I'll post those pages later.)

(Update April 25, 2014, More information on this drug here
"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")

Note: On my last CIDA/DFATD ATIP, I had questioned them to find out specifically what was being funded under the "Approved Activities" (1) for the five countries Afghanistan, Mali, Tanzania, Bangladesh and Sudan. I was told that "no records related to your request exist." This time I received some of the details of that request. I'll blog more about that later.

CIDA does IPPF site visits in only two of five countries

It seems DFAIT's (formerly CIDA) due diligence criteria of making field visits to ensure that the $6 million funding to IPPF does not include abortion services, didn't happen in three of the five countries involved.

This latest ATIP request to DFAIT was based on an email I had received previously from a CIDA media person that stated:

"Field visits to projects and regular monitoring by CIDA field representatives also provide key information that permits CIDA to determine and assess whether the implementing organization is performing or delivering services in accordance with the terms and conditions of the funding agreement."

So I asked for:

"all information regarding these field visits to the five countries benefiting from the $6 million funding to IPPF."

This is what I received.

There were site visits to Bangladesh between February 12, 2012 and Feb 23, 2012.

And this note:

"All partners were very pleased to have a CIDA officer visit. Some have been receiving funding for several years but have never had the opportunity to welcome a CIDA officer."

Sounds like this is the first time CIDA had done any checking as to how our funds are being used in Bangladesh in several years.

We know that FPAB [IPPF's member association in Bangladesh] does menstrual regulation in Bangladesh, but supposedly no Canadian funds are being used for this. But then we read this comment in the report under their "advocacy program":

"...the management team indicated that FPAB does a lot of advocacy work. Advocacy is part of everything they do, either at the policy making level through activities targeting the MoHFW (Ministry of Health and Family Welfare) or at the district and grassroots levels, whenever there is an opportunity during formal meetings with local authorities and religious leaders at training sessions etc. They envision this staying the same over the next few years."

Would that mean then, advocacy for menstrual regulation and abortions? One would assume so, since it is a well known fact that IPPF wants to make abortion legal everywhere and never shies away from telling us so.

The "background" portion of the information does make one reference that abortion services will not be funded under the initiative.

Pages 76 and 77 identify a site visit to Tanzania, but it says virtually nothing about how the funds are used here. It does say that:

"IPPFAR [IPPF Africa Regional Office] also mobilizes resources for its MAs ([member Associations], and advocates for sexual and reproductive rights at the county, regional and international level."

There's that "advocacy" word again.

And you may be asking, what about the due diligence that our money is not being used for abortion services is Afghanistan, Mali and the Sudan? Good question. My ATIP revealed this:

"Please note, no records were found for Afghanistan, Mail or Sudan."

Apparently those field visits and regular monitoring to three of the five countries to "determine and assess whether the implementing organization is performing or delivering services in accordance with the terms and conditions of the funding agreement." never even happened.

(Note: this ATIP was for the first Annual Progress Report for the project: 27 January - 31 March 2012, and for the Mid-year Report: 1 April - 30 September 2012. There will be additional reports for each year of the funding.)