Health Canada to allow ‘morning after pill’ without doctor’s prescription
By Barbara McAdorey

Health Canada announced on May 18 it was moving forward with its plans to amend the Food and Drug Regulations to allow the ‘morning after pill’ (MAP), also known as ‘emergency contraception’ (EC), to be sold in Canadian pharmacies without a doctor’s prescription. It would get Schedule II status, meaning it would still be dispensed by a pharmacist ‘behind-the-counter,’ but a visit to a doctor to obtain a prescription would not be necessary. Canadians will be able to give input on this proposal during a 75-day consultation period, beginning May 22.

Dr. Will Johnston, president of Canadian Physicians for Life, expressed concern that such a move could endanger the health of Canadian women and girls and raises serious issues regarding informed consent.

“Physical and clinical examinations by a physician are essential to good healthcare: to counsel patients on how to reliably avoid pregnancy, to determine sexually-transmitted diseases and abusive or coercive relationships, and to discuss health risks,” said Dr. Johnston. “MAP does not protect against STDs and instead of preventing a pregnancy, may terminate it. Such serious issues cannot be adequately addressed at a pharmacist’s counter.”

CNSNews.com reported in January that the Australian Medical Association, which had previously supported the government’s approval to distribute MAP without a doctor’s prescription, was now urging the government to reverse its decision because pharmacists themselves had raised concerns. “AMA ethics committee chairwoman Dr. Rosanna Capolingua said pharmacists were not prepared to deal with the sensitive matters arising when a customer wants the morning-after pill,” CNSNews reported. Dr. Capolingua said that the idea of a pharmacist being able to have a serious discussion about such sensitive matters as unprotected sex and on the need to use appropriate contraception in future, was “absurd.” Pharmacists complained, “we don’t understand the side effects to be able to do this.”

Health Risks

MAP is a multiple dose of an oral contraceptive, levonorgestrel, which is found in the birth control pill. Manufacturers have reduced the hormone content of oral contraceptives due to serious side effects and health risks. “Now women are being encouraged to use these same pills, in multiple doses, as post-coital ‘contraception,’” Dr. Johnston said. “The potential long-term impact of these high hormone doses, especially when used repeatedly, is worrisome and not being adequately addressed.”

Wendy Wright, Senior Policy Director of Concerned Women for America, says there has been a lack or absence of scientific studies on: MAP’s long-term effects; repeated usage of the drug; effects on adolescents; and the high hormone dosage.

“A drug’s safety at one dose or range of doses does not mean that the drug is equally safe at a much higher dose,” she said (see “Talking Points on the MAP, www.cwfa.org). “Yet proponents stake their arguments on decades of use of the birth control pill, a lower dose – which is not available over the-counter.”

On May 6, the US Food and Drug Administration rejected a plan to allow MAP to be sold over-the-counter at American pharmacies, citing a concern that it might be unsafe for girls under the age of 16.

Ms. Wright says that all studies presented to the FDA were based on unscientific, anecdotal evidence and focused on the drug’s efficacy in decreasing birth rate, not on the drug’s effect on women.

Barr Pharmaceuticals Inc, the manufacturer of the levonorgestrel MAP, Plan B, was unable to provide the FDA with any data on whether girls under 16 could use the drug safely without a doctor’s input. Barr has this posted on its website: “Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 as for users 16 years and older.” (www.go2planb.com/section/prescribing_info/) If such data can be produced, Dr. Steve Galson of the FDA would reconsider the decision, Reuters reported.

What studies did Health Canada rely on to decide to approve MAP’s distribution without a doctor’s prescription? Why did Dr. Galson and Health Minister Pierre Pettigrew come to different conclusions about the safety of MAP for girls under 16 years of age?

Yet some people believe Health Canada has not gone far enough and believe MAP should be available over-the-counter, meaning that even a pharmacist would not be involved. “The paternalistic requirement for consultation with a pharmacist is unwarranted,” writes Rebecca J. Cook, law professor at University of Toronto, in the National Post. “Authoritative and widespread evidence demonstrates that women can safely and effectively self-diagnose, self-select and administer EC?” She then goes on to say, as if to give evidence for this sweeping statement, that “over-the-counter availability of EC in France has been highly successful, contributing to the country’s decreasing abortion rate.”

There are three problems with this ‘evidence’: firstly, she doesn’t cite the source of her information, meaning it is doubtful it is based on any scientific study; secondly, the outcome she is discussing is the decline in abortion rate, which has nothing to do with the health risks of the drug on women and girls; and thirdly, even if it were a scientific study, and even if it were relevant, one could quote another study which showed different results. In Glasgow, Scotland, where MAP prescriptions increased 300 percent from 1992 to 1999, the number of abortions did not decrease. (“Deconstructing Rosie,” by Susan E. Wills in the National Review Online, March 21, 2002.)

Issues of Conscience

This is the same woman who wrote in the February, 2004 issue of the Journal of Obstetrics and Gynecology (Canada), when discussing the topic of physicians’ conscientious objections to prescribing ‘emergency contraception’ and referring for abortions, that “Physicians who feel entitled to subordinate their patient’s desire for well-being to the service of their own personal morality or conscience should not practise clinical medicine.”

What about Canadian pharmacists who oppose dispensing MAP for religious/ethical reasons? The Department of Health in the May 22 issue of the Canada Gazette under “Regulations Amending the Food and Drug Regulations (1272—Levonorgestrel)” says in section 21 that pharmacists will “have the right to refuse to dispense medication for moral reasons but they would be expected, as a standard of care, to refer the woman to another pharmacist, a physician, or health facility where the medication could be readily obtained.” (See http://canadagazette.gc.ca.partI/2004/20040522/html/regle1-e.html)

A pharmacist who believes MAP to be dangerous to the health of a woman and her unborn child, believes this to be true regardless of who dispenses the drug. “Passing the buck” to some other pharmacist does not make the drug any less dangerous, so such a pharmacist, if true to his or her conscience, cannot refer. One wonders how assisting (by referral) someone else to carry out an unethical act is not itself unethical.

MAP as Abortifacient

One of the biggest controversies surrounding ‘emergency contraception’ relates to how it works. The Department of Health says in the Canada Gazette that levonorgestrel “acts as an EC by preventing the release of an egg from the ovary, preventing fertilization of the egg or preventing the fertilized egg from attaching to the wall of the uterus.”

This latter mechanism causes an abortion, but Health Canada does not describe it that way because it erroneously defines “pregnancy,” as beginning after implantation – the same erroneous view held by the World Health Organization. Yet embryologists are in 100% agreement, says biochemist/biologist Dr. Dianne Irving, that a new human life begins at fertilization, not implantation. Health Canada further obscures this truth by referring to this young embryonic human life as a “fertilized egg.”

“Potential users of MAP must be told that this drug may abort a pregnancy so that they can make an informed decision,” says Dr. Johnston. Playing “fast and loose” with the English language, wrote Dr. Johnston in a recent editorial “patronizes the woman who must make an ethical judgement, by assuming that she can’t handle the truth.”

It is doubtful a pharmacist behind a counter in a busy shopping mart will be able to adequately address this important and sensitive issue with an uninformed adolescent, thereby precluding the young woman’s ability to give informed consent.

In her testimony to the FDA, Dr. Irving said that “there are many women and men who, although they may personally condone genuine contraception, would not personally condone or desire abortion. These people have the right to know what the objective scientific facts of human embryology are so that they may make a truly informed decision as to whether or not to buy or take levonorgestrel or any other contraceptive or ‘emergency contraception.’”

Sexually Transmitted Diseases

While Health Canada indicated that a label on the package would indicate that MAP does not protect against sexually transmitted infections (STIs), Health Canada does not seem to have addressed the problem that easier availability of MAP would likely lead to an increase in STIs/STDs.

A study by David Paton, Professor of Industrial Economics at Nottingham University Business School in the UK, entitled “Random Behaviour or Rational Choice? Family planning, Teenage Pregnancy and STIs,” found that between 1998 and 2001 in England, an increase in family planning services and availability of EC without a doctor’s prescription was associated with an increase in STIs (rate of 93.08 in 1998 increased to 119.27 in 2001). This seems to confirm the theory that because easier access to EC enables young people to reduce the risk of pregnancy, it acts as an incentive to engage in risky sexual activity.

In what we should take as an ominous warning that easy access to EC could also lead to coercion of women, Paton states, “This effect may be reinforced if the knowledge that (EC) is available weakens a woman’s bargaining power at the time when effective decisions over sexual activity are taken (Akerlof et al, 1996).”

Exploitation of Women

In her testimony to the FDA, Ms. Wright discussed the results of a study published in the December, 2003 issue of Social Science and Medicine, entitled “Supplying emergency contraception via community pharmacists in the UK.” Pharmacists and users of the MAP expressed major concerns about the easy access. One concern female pharmacists expressed, says Ms. Wright, is that “easy access to the morning-after-pill would result in men coercing women, particularly young or less assertive women, into having sexual intercourse against their will.”

Ms. Wright also includes an example from the June 10, 2002 edition of the Bangkok Post. MAP has been available over-the-counter in Bangkok for the past 15 years, and random studies showed that men are the most frequent buyers. “They buy the pills for their girlfriends or wives so that they don’t have to wear condoms and feel they’re at no risk of becoming a father afterwards,” said Nattaya Boonpakdee, program assistant at the Population Council (an agency dedicated to promoting and developing contraception and abortion methods.) “Some women I’ve spoken to said that they didn’t even know what they were taking; that the guy just said it was a health supplement.”

The article notes, “Although many feminists believe that the morning-after pill gives them more control over their own bodies, it would seem, judging from the few studies conducted so far, that it is actually being used by men to exploit women.”

That such an exploitation of women could happen in Canada is evidenced by the case of a Montreal man who was sentenced May 18 to one year in jail for aborting his girlfriend’s 14-week old unborn child by inserting a drug into her vagina without her knowledge because she refused to have an abortion (see story page 8).

Referring to the above example in her testimony, Ms. Wright said, “Providing over-the-counter access to the morning-after pill, which needs only to be swallowed, will ensure that it will be slipped to women without their consent or knowledge.”

There is no reason to believe that such abuses won’t also occur when distribution is from behind-the-counter – or will pharmacists in Canada be forbidden from selling MAP to men?

The Health Minister has a duty to put the health and safety of Canadian women before political ideology and commercial interests. Such a duty mandates that the proposal to dispense the ‘morning after pill’ without a doctor’s prescription be rejected. — BM