Canadian women have fewer options than their counterparts abroad when it comes to birth control choices. Creative Commons photo by Flickr user vociferous.

Sitting up on the examination table, I can hear my sterile paper gown crinkling with every movement. The gynecologist sits a few feet away, looking up at me, and I feel like a stage performer as I explain the reason for my visit. “I’ve tried and hated almost every type of hormonal birth control,” I tell her. “I want to know about non-hormonal options.” She nods when I reveal I’m in a long-term, monogamous relationship; she tenses up when I say I’m interested in an IUD or a diaphragm.

My request was uncommon. Hormonal contraception is the unequivocal norm for most young Canadian women, and research for other options is virtually non-existent in this country. Birth control is low on the health agenda, and this oversight is putting Canadian women at risk.

In the last decade, I’ve sampled nearly ten kinds of hormonal contraception. By the age of 19, I had tried five different types of oral contraceptive. Puberty came with a prescription for the pill to help control heavy periods. In university, hormonal contraception threw me into an emotional frenzy. Going from the pill to the Depo-Provera injection to the Nuva Ring, I experienced symptoms that included an obsession with my weight, loss of my sex drive and intense mood swings. As a responsible young adult in long-term relationship, I was a good candidate for a vaginal barrier method or an intrauterine device (IUD), but I was unaware of those options and they were never mentioned. Campus physicians continued to advocate hormonal methods, convinced they could find “the right match.” Still, my body was completely uncooperative. I assumed I was the problem.

My latest attempt, a consultation with a gyno, earned me a prescription for a diaphragm. After trying more than a dozen pharmacies, I discovered that diaphragms are nearly non-existent in Canada. A call to the manufacturer revealed that in 2010, less than 100 devices were distributed across the country.

Finally turning online, research led me to the FemCap, a highly recommended new version of the cervical cap. An American product, it’s said to be comfortable, reusable, purchasable online and most importantly, hormone-free. I included the recommended organic spermicide with my order, because it’s not available in Canadian pharmacies.

When my gadget came in the mail, my boyfriend and I watched the unintentionally hilarious instructional video, which features a real vagina and animated sperm whose mission to fertilize is thwarted by the FemCap. To be sure, I ran the device by my family doctor. She’d never even heard of it, but she was enthusiastic. After giving it her seal of approval, she asked to keep the instructional pamphlets I brought in.

Advancement in non-hormonal birth control is not a popular field of research and statistics show Canadians are particularly unaware. The United Nations’ 2009 report on contraceptive use says the world’s most popular form of reversible birth control is the IUD. This is the method of choice for 14 per cent of the world’s women. While the report shows the pill is the most popular option for most developed countries, on the global scale only nine per cent of women rely on it. In Canada, one in every five women uses oral contraceptives. The condom is second in popularity with 15 per cent, followed by traditional techniques like the rhythm method at nine per cent. The IUD and vaginal barrier methods (including the diaphragm and the FemCap) are each used by only one per cent of women. In contrast, a whopping 13.5 per cent of European women report using an IUD and 14 per cent rely on natural family planning.

So why are Canadian women so dependent on hormones?

Cindy Weeds, the coordinator of women’s programming at Planned Parenthood Toronto, explains that North American women have normalized the consumption of hormonal birth control. “Often we see women who come in and all they know about is the pill,” she says. Whether this is the cause or the effect of the current contraceptive landscape is difficult to say. Proliferation of hormonal methods is cyclical: as these contraceptives become more accepted, the industry becomes more profitable and advertising increases. This ensures the products stay on the radar and gain approval, re-launching the cycle. “Certain kinds of pills are really heavily marketed, particularly to young women,” says Weeds.

One of the consequences of this consumption cycle is a decrease in demand for non-hormonal products, reducing their supply and leading to a dearth of available information.

Fear of pregnancy is also a consideration. The pill boasts a 99.9 per cent rate of effectiveness, while the diaphragm has a failure rate between four and eight per cent, a margin of error too risky for many.

In Canada, advancements in the study of contraception are not a priority: little research is done to develop any new methods of birth control, let alone non-hormonal alternatives. Since 2008, the Canadian Institute of Health Research has spent $916,226 on birth control-related research, none devoted to new developments. In contrast, research devoted to pregnancy and conception received more than $20 million in funding, 22 times the amount allocated to birth control. And for example, while $14,000 was given to a British Columbia conference focused on sexual health education, $20,000 was allocated to finance events honouring the oral contraceptive’s 50th anniversary.

Women will often accept the side-effects of hormonal birth control because their fear of conceiving is so great. But, as Amy Sedgwick, owner of Toronto sex and health store the Red Tent Sisters, says, “there’s really no other comparable situation where millions of healthy people are taking a daily drug.” Numerous studies warn of the effects of hormonal contraception. The pill is said to impair muscle gain and increase women’s risk of heart attack, stroke and cervical cancer. Studies have also shown that women who use hormonal contraception are more susceptible to mood disorders and sexual dysfunction, and prolonged use of Depo-Provera, the hormonal injection, has been linked to bone-density loss.

Birth control has been lauded as a bastion of feminist liberation and empowerment, but our dependence on hormonal methods is worrisome. As women wait longer than ever to have children, they are relying on these drugs and devices for increasing periods of time, sometimes decades. Considering the volume of research revealing frightening long-term effects, hormonal birth control should be dispensed with a plan and a well-thought-out exit strategy. Most importantly, non-hormonal alternatives should be discussed, and used, in Canada.

Hormonal birth control disconnected me from my body and made me feel uncertain about my wellbeing. Using the FemCap has kept my health and sanity intact, and disturbing instructional video aside, my partner is a big fan. Just don’t make him watch it again.

Apo-TriAvir, the generic HIV/AIDS drug. A Canadian law making its export easier is likely finished in parliament. Image courtesy Apotex.

In March, Canada came improbably close to establishing a system to deliver drugs cheaply and quickly to poorer countries. In a vote of 172 to 111, the House of Commons passed Bill C-393, which would have streamlined Canada’s Access to Medicine Regime, a program to provide low-cost generic drugs to the global south. It wasn’t to be: the senate stalled, waiting for the vote of non-confidence that precipitated a spring election. That vote came four days later, effectively trashing the bill.

CAMR allows generic drugmakers to export cheaper versions of brand-name drugs to developing countries, without needing the permission of the patent-holders. “We have tremendous capacity to help address a particular need,” says Richard Elliott, executive director at the Canadian HIV/AIDS Legal Network. But CAMR’s cumbersome red tape kept manufacturers away. Says Elliott: “To leave in place a regime that is not working would be harming millions of people who need access to medicines.”

The program had only been used once since it was introduced in 2005. In 2007, Apotex, the largest Canadian-owned generic drug company, shipped enough HIV medication, Apo-TriAvir, to treat 21,000 patients in Rwanda [PDF]. Apotex says the final shipment went out in 2008. “We’re not likely to repeat the process under the current regime,” says Bruce Clark, Apotex’s senior vice-president of scientific and regulatory affairs. “It’s not just our decision, it’s a practical reality that no second country has made a request under the regime because it’s so complicated.” Bill C-393 would have simplified that process, but its future looks doubtful.

When C-393 passed in the House of Commons, it was supported by 26 Conservative MPs; 25 of those were re-elected, but the bill’s prospects in the new Conservative-dominated parliament look dim. “We saw what Harper did in the senate with the bill,” Elliott says.

On May 5, Elliott discussed CAMR’s future with other major advocacy groups. They’ve decided it’s not time to give up, but it will take time to re-assess the political climate before drafting some next steps. “The legal landscape is more challenging now than before,” he says. “But it’s worth trying to gather some intelligence and make a more informed assessment as to what the prospects might be before moving forward.”

Even with such slight optimism, Elliott expects the earliest the bill could be re-introduced—if at all—would be this fall.

Compiled by Dylan C. Robertson & Victoria Salvas

This election means death. Not only have Ottawa scrums, filibusters, and drawn-out committees been killed, pieces of legislation making their way through parliament have all met a harsh end as politicians take to the campaign trail.

Before a bill becomes law, it is introduced in either the House of Commons or the Senate. Subsequently the bill goes through readings where it is introduced, given a number code and debated. It can be read again, amended then passed, from the House to the Senate but only becomes law if it is given Royal Assent by the Governor General.

But bills are stopped in their tracks when an election is called. We tracked down the people who pioneered five of the most important bills that died on the order paper when the writ dropped. We asked what they thought of the abrupt death of their projects and if they’ll attempt rebooting them.

While government bills (titled C- with a number under 201) can be reintroduced at an advanced phase with the consent of the House, private members’s bills and motions are entered in a lottery to determine their Order of Precedence, meaning the order in which they can be re-introduced. Only 30 members per session have their motions considered, although the list is replenished if all motions are dealt with.

Here’s a look at the five bills that may or may not rise again:

1. Cheaper HIV Drugs:

Bill C-393, An Act to amend the Patent Act (drugs for international humanitarian purposes), was introduced by then NDP MP Judy Wasylycia-Leis in May 2009. After she left to run for mayor of Winnipeg, the bill was adopted by another NDP MP, Paul Dewar.

The bill, which came to be known as “the AIDS drug bill” would’ve allowed generic drug makers to supply their products to developing countries, so they could fight diseases like tuberculosis and malaria, and help the world’s 15 million AIDS victims. Apotex Inc. had promised to make much-needed antiretrovirals for children, should the legislaiton pass. The bill, which was passed earlier this month by the House of Commons, was sabotaged by its review committee and then by the Conservatives’s attempt to effectively whip the senate, feeling it would hinder Big Pharma.

“It’s pretty outrageous,” said Richard Elliott, executive director of the Canadian HIV/AIDS Legal Network. “This bill had a lot of potential, and we pushed really hard to get it to pass. We had a lot of support from MPs in all parties.”

Dewar said he plans to reintroduce the bill. “We have to abolish the senate though, first,” he laughed. “That’s my plan. Well I’m just joking… but not really.” Dewar noted the bill was lucky to be successfully transferred after Wasylycia-Leis’s leave, as it is not an automatic process. “It was revived when actual co-operation broke out in the House of Commons,” he said. “Through unanimous consent, I was able to pick the bill up. “I’m ready, able, and willing to carry it forward after the election,” said Dewar, who hopes it ranks high in the order or precedence. “There’s so much public support for it. I don’t think they could get away with this again.”

2. Civilizing parliament:

Private Member’s Motion M-517 proposed a reform of Question Period. Conservative MP Michael Chong’s pet project aimed to civilize parliament’s most savage — and ironically unproductive — 45 minutes each sitting day.

The motion sought to strengthen how much discipline a speaker can give, lengthen the alloted time for each question and answer, and aimed at “examining the convention that the minister questioned need not respond.”

“Parliament needs to be reformed and I think the reform of parliament should begin with the reform of Question Period,” said Chong. If passed, the motion would have also stipulated who should be asked questions, most notably dedicating Wednesday exclusively for questions to the Prime Minister, and requiring ministers be present for two of the other four days. Chong noted that he was listed in the Order of Precedence for the first time in six years, and said he would re-table his motion in the rare chance he was listed for the next session. “I’m disappointed that the committee didn’t have a chance to deal with it before the election.”

Chong explained that while many members add motions and bills to the order paper solely to generate publicity for an issue, he fully intends to enact this reform. “I’ll continue to work on this issue through whatever mechanisms are available to me after the election,” said Chong. “Because this problem isn’t going away and I think Canadians want it to be addressed.”

3. Protecting trans rights:

Bill C-389, An Act to amend the Canadian Human Rights Act and the Criminal Code (gender identity and gender expression), was a private member’s bill sponsored by NDP MP Bill Siksay. Introduced in early 2009, the legislation would have make it illegal to discriminate based on gender identity, and aimed to protect transgender individuals by amending the Human Rights Act.

These amendments would have also been made to the Criminal Code, rendering these acts of discrimination hate crimes. The House passed the bill in February, against Stephen Harper’s wishes. However, the fact that it received “unanimous support from the Bloc, several Conservatives, and the Liberals bodes well for the next parliament” says Siksay. The MP is confident in the future of the bill; passing it again will demonstrate the governments’ “commitment to human rights.”

4. Improving First Nations’ water:

Bill S-11 Safe Drinking Water for First Nations Act, was introduced in May 2010 and would have developed federal regulations for governing water provision, disposal and quality standards in First Nations communities.

An issue that has received much attention recently is the issue of providing First Nations reserves with safe drinking water. An assessment from 2001-2001 found that three quarters of the drinking water systems in First Nations communities were at risk.

Despite the dire situation on many reserves, many First Nations leaders criticized the bill, feeling they were left out of the creating of the legislation and not offered funding to get it off the ground. The Assembly of First Nations felt that the bill presented lofty goals but sparse plans for financial investment and support, which in the long run, could leave reserves in worse condition.

5. Copyright reform:

Bill C-32, An Act to amend the Copyright Act, was the third attempt at copyright reform killed by an election call, dragging on a 14-year effort.

The bill sparked controversy for attempting to criminalize the use and promotion of software that circumvents digital locks, generating high-profile criticism, a minister’s comment that critics were “radical extremists,” and an indutry-led astroturfing campaign. But the bill also aimed at tackling online piracy, and making it legal to transfer music from CDs to iPods.

MP Tony Clement, who introduced the bill as Minister of Industry, told us he plans to reintroduce the bill if re-elected. “It’s just another example of important legislation that has now been discontinued because of the opposition parties passing a motion of non-confidence,” said Clement. “This is a very necessary piece of legislation to help regularize certain habits of consumers and also protect artists from wealth-destroying pirates. “I’m hoping that if we get a majority government, we can actually concentrate on the issues like C-32 and privacy protection and other aspects of the digital economy.”

Photo by Joanna Pecha

On March 18, 2000, Terence Young was at home catching up on the weekend paper when his 15-year-old daughter, Vanessa, came to ask his permission to go out with some friends that evening. Exhausted and not relishing the idea of another conversation about Vanessa’s curfew time, Young asked her to wait until after dinner. There was nothing remarkable about it.

But as Vanessa turned to leave, she suddenly went limp and collapsed, her head making a loud thump on the carpeted floor. Young ran to her, calling out to ask whether she was okay, thinking momentarily that it could be a joke, an overdramatic gesture by his teenage daughter. It wasn’t. As she lay motionless on the floor, Young frantically felt for a pulse, finding the spot on her neck where his first-aid training had taught him to press his fingers, but there was nothing. An ambulance rushed Vanessa to the hospital, and an exhausting, haunted night followed as the family kept vigil in intensive care. The next day, Vanessa Young died.

Her cause of death was later determined to be cardiac arrest, caused by the effects of Vanessa’s bulimia nervosa and possibly an undiagnosed underlying heart defect. But there was another factor: Vanessa had been prescribed a drug called Cisapride—better known by its trade name, Prepulsid—to assist her digestion and prevent vomiting. Terence Young was later to learn the drug had been linked to irregular heartbeats and other cardiac problems. In July 2000, Janssen-Pharmaceutica Inc., a subsidiary of drug giant Johnson & Johnson, voluntarily pulled Prepulsid from U.S. pharmacy shelves. In August 2000, Health Canada pulled it from the Canadian market. On April 24, 2001, a coroner’s jury concluded that Vanessa Young’s arrhythmia and cardiac arrest resulted “from the effects of bulimia nervosa in conjunction with Cisapride toxicity and possibly an unknown cofactor such as congenital cardiac defect.”

The potential danger of Prepulsid was known, but key information about the drug didn’t make it to the right people at the right time. Eventually the right decision was made—but it was too late for Vanessa Young.

Canada’s drug-approval process suffers some serious flaws. The proceedings lack transparency; scientific data often goes fully or partially unpublished; once on the market, approved drugs seldom receive long-term monitoring for adverse effects; compared to other countries, drug labelling is less rigorous; and the whole process is paid for, in large part, by the same companies it is supposed to be regulating.

To be fair, Health Canada, the ministry responsible for approving pharmaceuticals, is often in a difficult position: patients and doctors want effective treatments made available quickly, but the department’s job is to thoroughly test drugs for safety, which takes time. Speeding drugs to market and protecting public health are two mutually exclusive goals, afflicted at every stage by interests that are often financially, and sometimes emotionally, vested. And at every stage, the pharmaceutical companies themselves are there, embedded in the approval process.

The result is a system with conflicting loyalties, bizarre blind spots, and, sometimes, dangerous outcomes. Why is it that Canada lags so far behind in providing an open, accessible drug-approval process? I sought out some of Canada’s leading experts on health policy and drug safety to try and understand what in our drugapproval system is broken—and how we can fix it.

Part of the problem of understanding Canada’s drug-approval process is that so much of it takes place behind closed doors.

“The way that we deal with drug approvals is actually quite different than the U.S., in that theirs is a much more open process,” says Dr. Barbara Mintzes, assistant professor in the department of anesthesiology, pharmacology and therapeutics at the University of British Columbia. When the U.S. Food and Drug Administration, for instance, approves a drug for the market, the full review report is published online. Expert advisory committee meetings are open to anyone and transcripts are published on the FDA’s website. The public is invited to submit input, and scientific reviewers’ comments are also made public. Almost none of that happens in Canada.

Dr. Joel Lexchin, a professor at the School of Health Policy and Management at York University in Toronto, agrees that lack of transparency is a problem.

“The FDA demands that drug companies submit the raw, clinical data,” says Lexchin. “Then they will do their own reanalysis of the data to make sure that the way the companies analyzed it is appropriate.” Drug trials in the U.S. are also catalogued with redacted information in an online registry. “Not only do you know what trials were started but you’ll be able to see what the results of those trials are,” says Lexchin. “Health Canada doesn’t require the posting of trial results.” In contrast, the comments of Health Canada researchers reviewing drug company applications are never made public. In fact, the public may not even find out that a drug is under review.

“The drug-approval process in Canada is secret,” says Mintzes, “in that when a drug is being considered for approval, there’s no announcement to the public by Health Canada to say that’s happening. It’s up to the company whether or not they want to publish the clinical trials [they submit] and often they will decide to publish only a subset of their studies.”

Health Canada’s approval process, then, is a kind of black box: drugs go in one end, and some emerge at the other, but what exactly transpires inside to influence that decision is unclear. (Health Canada’s only response to interview requests for this story was to refer me to its website.)

Many critics say that money exerts too big an influence on approvals. The biggest culprit is user fees, in which pharmaceutical companies pay the government to fund the approval process. User fees were introduced in 1995, partly in response to federal budget cuts, based on the idea that, because they benefit from having their drugs for sale, drug companies should shoulder some of the cost of approving them.

“I think this is a mistake,” says Lexchin. By 1999, the Therapeutic Products Directorate, the Health Canada department responsible for assessing drugs’ safety and efficacy, got close to 70 percent of its budget from the companies it was supposed to be regulating. Today, Lexchin claims, it’s about a third, though recently proposed regulations from Health Canada aim to cover 50 percent of TPD’s budget with user fees. At that level, critics question who’s actually setting the agenda—the pharma companies or the public interest?

“User fees are totally inappropriate,” says Terence Young, Vanessa’s father, who is also a Conservative MP in Oakville, Ontario, and founder of the advocacy and research group Drug Safety Canada. “They create a situation where a drug reviewer feels that the company is like a client, that they should be working fast to get this drug approved because these companies are paying up to 50 percent of the cost of having drugs reviewed for approval. That is an inappropriate relationship.”

After the death of his daughter, Young became a fierce critic of the pharmaceutical industry and wrote about the civil and classaction lawsuits subsequent to Vanessa’s death in his book Death by Prescription. He echoes the sentiment—common enough to have become cliché—that drug companies have put profits above patients.

“Big Pharma’s profits are multiples, in most cases, of other industries,” says Young. “You cannot overstate their influence on modern medicine. We spend more money on pharmaceuticals, both prescription and non-prescription, than we do on doctors.”

In Canada, the effect of user fees is not just that it makes the drug companies clients of Health Canada, expecting value for money; the user-fee structure also influences approval deadlines. The 2004 User Fees Act gives Health Canada a set timeline to approve new drugs; if the agency misses its deadline, there are financial penalties: user fees for the following year are cut. “If you go, say, 20 percent over deadline, then next year the user fees are going to be cut by 20 percent,” says Lexchin.

That pressure to approve, says Young, inevitably influences the decisions of Health Canada reviewers. “Drug reviewers should not feel that their job depends on, in any way, approving a drug,” he says. “You approve a drug when you believe it’s effective and safe,” he says. “You don’t approve it by any given date. And if it’s doubtful, you don’t approve it.”

Lexchin and Young both argue for the elimination of user fees, to make the whole process publicly funded and cut down on industry influence. Young proposes a mandatory levy on pharmaceutical companies so they still fund the process, but without the strings attached.

Once a drug is on the market, additional problems crop up: follow-up research on drugs is relatively rare, and drug labelling is inconsistent.

With few exceptions, once a drug reaches the market and is being prescribed routinely by doctors, there is no system evaluating the long-term effects or adverse reactions for prescription drugs.

“Health Canada, at this point, doesn’t have the ability to require companies to undertake post-market trials; all they can do is ask companies to do it,” says Lexchin. He draws attention to a Health Canada policy called Notice of Compliance with Conditions that approves the drug but requires further testing. “They will approve it on the requirement that companies undertake additional trials to show that what looks promising actually is promising.”

But there’s no reporting on the progress of meeting those conditions. “You have drugs that were approved nine years ago under this policy that still haven’t met their conditions, and you can’t find out why because it’s considered confidential,” says Lexchin. “With the cancer drug Iressa, the trials showed it didn’t work, but Health Canada still left it on the market.”

Lexchin believes it’s probably still on the market because some cancer doctors think that, although it doesn’t work statistically, it might work on individuals. “We’re always dealing with statistics,” he says.

Monitoring of adverse drug reactions across the country is largely confidential. Young says it’s meaningless: “Health Canada never insists follow-up studies be done; they don’t even call the drug company back and say, ‘Did you do those studies?’ Because they get approval, and it’s open season.”

Pharmaceutical labels are notoriously difficult to read, and potential side effects or drug interactions get lost in a sea of technical and legal language. “They’ll say, ‘See look, here on page 19, right near the bottom it says you shouldn’t take it with grapefruit juice, so don’t say we didn’t warn you!’” says Young. “The labels are written by lawyers, for lawyers, to confuse. They should issue effective safety warnings in plain language so patients and doctors will know when a drug is safe.”

To try and reform some of the problems he and many doctors see with the Health Canada drug-approval regime, Young has tabled a private member’s motion to create an independent drug agency that focuses purely on safety. “If Air Canada had a crash of one of their planes, you wouldn’t ask Air Canada to investigate the crash. So when a drug company has a crash of its drug, like Prepulsid, why would we ask them to investigate their own crash?” he asks. “Prescription drugs used as prescribed in hospitals with no error are the fourth leading cause of death in our society. That’s why everybody has an interest in this.”

While the picture is troubling at the federal level, experts say provincial drug-review bodies do a better job of sorting pharmaceuticals by safety and efficacy. Because the provinces bear most of the cost of providing health care through provincial health plans, they have traditionally done a better job of prioritizing drugs that actually work well, since they don’t want to pay for ineffective treatments. Even so, the provincial bodies suffer some of the same problems of transparency and accountability.

Once Health Canada has approved a drug, the second level of screening is the Common Drug Review, a body funded jointly by the federal government and the provinces. There, a group of experts examines new drugs coming to the market. The provinces, though their processes vary, are responsible for deciding what drugs will go on pharmacy shelves, how much they will cost, and how to best use provincial dollars to pay for them.

“What they will do is look at that drug and compare it to other treatments in its class. They will determine whether the drug is costeffective to be used by the provinces,” says Alan Cassels, a drug policy researcher at the University of Victoria’s faculty of human and social development.

“Health Canada might review a dozen cancer drugs and say they’re all safe and efficacious. But that doesn’t help the provinces decide if they should fund it or not,” says Cassels. “And that’s really the information the provinces need in order to make decisions about whether they should be covered.”

“Health Canada’s standard of efficacy is so low that all you have to do, because of so-called commercial rights, is prove that your new drug works slightly better, even one percent better, than placebo and you can get it approved based on efficacy,” says Young. “The provinces, on the other hand, because they’re concerned with money and the cost of the drug, they actually demand a higher standard of efficacy than Health Canada.”

Two projects are trying to address some of these problems, to make at least part of Canada’s drug-approval process more transparent and open to the public.

Set to launch this spring, the pan-Canadian Oncology Drug Review, or PCODR, is a national review board specifically for cancer drugs. Funded by the provinces (except Quebec, which opted out) PCODR will make recommendations to the provinces on which cancer treatments would be most effective to fund. Notably, the PCODR review process will be much more open and transparent than the current structure.

“I’m very pleased that PCODR is going to include patient representatives,” says Dr. Chuck Blanke, head of medical oncology at the B.C. Cancer Agency and PCODR steering committee co-chair. “Everything is going to be as transparent as possible. Reviews will be posted on the website and there will be invited commentary from pharmaceutical companies, but also from patients and patient-advocacy groups.”

The Therapeutics Initiative is another example of an effort to pry open the approvals process. The initiative acts as an independent drug bulletin. Researchers look at the clinical trial evidence of safety and effectiveness of drugs after they’ve been approved for marketing, and the “independent” part is what’s key. “With independent drug bulletins, there’s a commitment not to have any financing or advertising from pharmaceutical manufacturers,” says Mintzes, who does research for the group.

Mintzes agrees that the provinces generally have a more transparent, better-informed drug-approval process. The Common Drug Review, she says, has improved the situation because provinces can share the cost of research, eliminating expensive duplication. “I think it’s been a big advance, and useful particularly for the smaller provinces, not having to review the same scientific data separately. Recommendations are posted on the Common Drug Review website, so it creates a situation of greater trust.”

Time constraints remain a problem, however. “Clinical reviewers are being asked to do a full systematic review within a short time frame of six weeks,” says Mintzes. “That’s a pretty short period of time for the depth of the report being expected. They get the same pressure from industry in terms of drug approval for marketing—pressure for the decisions to be made very quickly.”

And like at the federal level, technical details are still bound by confidentiality agreements. “Which is crazy,” says Mintzes, “if you think that this is evidence of potential for benefit or harm of a pill or medicine that a person is actually going to take. Those people, and the doctor who is recommending it, and the whole community, should have access to the full body of scientific evidence.”

Pharma companies generally come across as the villain in these stories, and for good reason: these are large, multinational corporations that reap huge profits exploiting government-aided monopolies on life-saving drugs. Stories abound of Big Pharma wining and dining doctors to cajole them into prescribing more. Of flying them to Caribbean resorts for what in the industry are called “continuing medical education” sessions, but which are actually just marketing junkets. Of drug-company sales representatives quietly persuading doctors to prescribe “off-label,” for conditions the drug wasn’t originally intended.

But experts say that what the pharma companies don’t do can be just as harmful to patients.

Fewer than 10 percent of new drugs are considered “breakthroughs” that substantially improve efficacy or attack a disease with a novel approach. The rest of the business consists of making slight tweaks to already-successful compounds. “It’s always these ‘me too’ drugs,” says Cassels. “You have a product, and if you modify a few molecules you can come up with your own version that’s almost the same but different enough so that you can get your own patent. ‘Me too’ drugs … are much less expensive to develop.”

“There are lots of diseases out there that we just don’t understand enough about,” says Lexchin, “and putting all your money into looking for drugs that are actually going to cure something—when you’re dealing with processes that are not well understood—is a big gamble that drug companies don’t want to take. So they’re going to go for, in general, the easy processes for new drugs, rather than looking for these real major breakthroughs.”

Frustratingly, there have been breakthroughs in Canada that, because they aren’t patented—and therefore are unlikely to be highly profitable—struggle to find funding even to finish clinical trials.

For example: dichloroacetate, or DCA, an inexpensive substance that has been used for decades to treat metabolic disorders. Researchers at the University of Alberta believe it could be used as an effective treatment for many forms of cancer, too. Research has shown that DCA can cause regression in several cancers, including lung, breast, and brain tumors. The next step is to run clinical trials on human cancer patients. But these trials may have to be funded by charities, universities and government. Drug companies aren’t interested, because without a patent, there’s little money to be made.

“Because drugs tend to be developed by for-profit companies, they’re only interested in products where they’ll have a monopoly for whatever the patent period turns out to be,” says Lexchin. “If they’re going to put all this money into it, then they’re going to want to be sure that nobody else can make that drug for whatever that patent period is. These things tend to be orphans.”

As Cassels confirms, “So much of what drives drug discovery is the ability to patent stuff. If they discovered that apple seeds cured cancer, no one would ever hear about it. Sad, but true.”

It doesn’t have to be this way. Despite the seemingly insurmountable obstacles facing those who would like to see a more open, transparent drug-approval process, the more engaged the public is through knowledge and dialogue, the better chance we have in creating a fully accountable process.

The experts concur that a more transparent, independent drug-approval process would raise Canada’s drug-approval system to levels already attained by many European countries and the U.S. One thing is for certain: an approvals process funded largely by the pharmaceutical industry itself is unacceptable and represents a threat to patient safety.

Prioritizing efficacy and thorough, truly independent safety testing will help create a situation of greater trust. Research focused on developing better drugs through patent reform is not an outlandish gamble, and should be recognized as inherent to the pharmaceutical business model and supported by government regulation. Safe, effective drugs are an integral part of our health-care system. But the current approval process is needlessly secretive, incomplete, and vulnerable to private interests. What’s at stake is not simply the public’s right to know, or wasted government spending, but the health and well-being of millions.

The birth control pill has been a major game changer in the arena of women’s reproductive rights, opening up new doors in society and the workplace. But, in the wake of the birth control pill’s 50th anniversary on the market in the United States and its 40th in Canada, a major question remains: will there ever be a version for men?

The development of a male pill has been a longstanding joke in the pharmaceutical industry, where someone is always willing to predict that the pill is “five to 10 years away” from becoming a marketplace reality. While this ongoing delay is due in part, to the technical challenges of developing a reliable contraceptive formula for men, backward assumptions that men would refuse to take a male birth control pill have arguably proven to be a much greater obstacle.

Researchers, however, have actually proven the opposite. A 2005 international survey conducted by Berlin’s Center of Epidemiology and Health Research found that a majority of men reported interest in using some form of oral contraception, a finding that is supported by two other studies. “I think modern men would like to take part in this decision,” says Ken Rosendal, the CEO of Spermatech, a Norwegian company currently in the early stages of developing a non-hormonal male birth control pill. “A pill for men would have less side effects than a hormonal pill for women.” Rosendal says, however, that funding is a key barrier in the development of such a pill; while biomedical research companies like Spermatech may have the scientific know-how to make the male pill a reality, finding investors to cover the costs necessary to bring the drug to market (an estimated US$2 billion, according to Rosendal) remains a constant challenge.

This means that, until society decides to catch up to science, the male pill will continue—year after year—to remain five to 10 years away.

Creative Commons photo by Flickr user Striatic

I’m not afraid of labour.

I’m not afraid of the intense pressure of my uterus contracting, tightening, pushing…

My cervix slowly dilating… Once open zero centimetres and currently stretching to a whopping 10 centimetres? Bring it!

I’m not even scared about pushing my baby into this world and the likelihood of my vagina tearing.

What I am terrified of is being induced.

There are a couple ways of inducing labour which, when applied to a healthy mother with a low-risk pregnancy, usually happens because she has gone over her “due date.” From what I can tell, more often than not, they cause problems for both the mother and baby.

The most common medical ways to induce labour is with synthetic drugs oxytocin and prostaglandin. Prostaglandin-mimicking drugs like Cervidil and Prepidil are used to thin the cervix and oxytocin-imitating drugs like Syntocinon or Pitocin are used to bring on contractions through intravenous injection.

Some of the reasons why I have no interest in being induced this way:

• While Cervidil is inserted like a tampon and Prepidil is a gel, Syntocinon and Pitocin are given intravenously. Being hooked up to an IV limits mobility making natural pain relief (bath, shower, moving around) more difficult.
• Pain relief is especially important after an induction because as if natural labour didn’t hurt enough, these drugs cause unnaturally strong contractions, often leading to what is known as the cascade of interventions.
• Induction in this way can cause fetal distress (depressed fetal heart rate patterns and decreased oxygen availability.) This often results in the use of forceps, vacuum extraction or C-section—all part of the cascade.
• The unnatural contractions means a woman is more likely to use pain medication (ie: an epidural, a common next step in yes, the cascade…)
• Having an oxytocin drip like Syntocinon or Pitocin, will usually mean continuous fetal heart monitoring. This makes going into the shower or tub for some natural pain relief (warm water) impossible.

I think when my baby’s ready to come out, she’ll come out. They predicted she’d be six pounds at birth, so I would be more than happy to give her a little more time to bake in this oven. If there is plenty of amniotic fluid left, and the baby is not under stress, there’s no need for her to be born so immediately.

It’s important for people (hello, grandparents!) to realize the due date means very little and is only an estimate. It assumes that all women run on a perfect 28-day cycle and that we all ovulate at the same point in that cycle. But that’s not the case.

Only something like three to five per cent of women deliver on their anticipated due date, and most of the time doctors will wait  between seven and 10 days before insisting on induction.

At my last appointment , I talked to my doctor about what would happen if I went over my due date (February 9 — yesterday!). She said she’d give me a week and after that, yes, she’d like to hook me up to an IV, and likely give me Syntocinon.

She was pretty responsive when I asked if there were alternatives to an intravenous intervention. We sorted out the fact that I did not want to be hooked up to an IV unless it was absolutely necessary and she said the alternative could be Cervadil. But if Cervadil’s job is to thin my cervix; at 37.5 weeks it was already 80 percent effaced, I’m not sure what the point is.

I was also surprised and hugely relieved when she told me I could, of course, decide not to have the induction so soon, bringing me closer to 42 weeks if I wanted. I would have to schedule regular non-stress tests to make sure everything was okay in there, which was fine by me.

Not every woman realizes that while the doctor might like a patient to deliver no later than a week after her due date, and if there are no medical complications that would make induction necessary to save the baby/mother’s life, whether or not to be induced really is the mother’s decision.

Luckily, sex is the best drug

There are perfectly natural ways to rustle up a little prostaglandin and oxytocin. Why not bring on labour the way this whole pregnancy thing started?

Semen is the most concentrated source of prostaglandins that exists. The synthetic Cervidil and Prepidil can’t compare. These prostaglandins that occur naturally are not associated with the host of potential problems that come along with the other stuff—won’t cause fetal distress, a ruptured uterus, unnaturally painful contractions etc. Getting some semen on your cervix will help it thin—a necessary step in labour.

Breast stimulation, which goes quite nicely with intercourse, releases oxytocin. Orgasms do the same. When oxytocin is released the uterine muscles contract! That sounds a little more fun than an IV.

In the end, the baby will usually come out when she’s good and ready. Who would want to leave the comfort of a warm, cozy womb anyways? Take your time, baby.

Sources: Ina May’s Guide to Childbirth. While this book has largely succeeded in helping me feel worse about delivering in a hospital as opposed to at home, it has been a great resource, one I relied on heavily for much of the information in this blog post.

Last November, the findings of the first study on boys and Gardasil — the vaccine that protects girls from four types of human papillomavirus — were released by pharmaceutical giant Merck. The good news is it works, preventing 90 percent of male HPV cases. The bad news is that Canada, unlike Australia and some European countries, has yet to make Gardasil accessible to boys.

Photo by Davide Guglielmo

Since the vaccine became available to Canadian girls in August 2006, more than a million doses of Gardasil have been administered, in part through a government-funded program, and with no major reactions reported in Canada. But despite its apparent success, there’s been no mention of federal funding for male vaccinations, and Health Canada won’t comment on where Gardasil is in its long approval process, citing “proprietary information.”

Health Canada estimates that nearly 75 per cent of sexually active Canadians will be infected with HPV in their lifetime. This fact has Dr. Paul Randall, a Toronto-area family doctor, calling the vaccination of boys “a no-brainer.” He explains that the first step toward eliminating HPV is to vaccinate male carriers — largely symptomless, unknowing spreaders of the virus.

So what’s the problem? According to Randall, it’s the cost. At a wholesale price of $400 for the three administered shots, Gardasil is said to be the most expensive vaccine on the market. For the threeyear period from 2007 to 2009, the federal government forked out a hefty $300 million for Canadian vaccination programs, and if approved and administered for boys as well, Gardasil’s cost to our government is set to double.

Dr. Elizabeth Saewyc, an expert in adolescent health, isn’t surprised by the government’s inaction. She believes Gardasil likely will be approved for Canadian boys, but she doubts we’ll soon see boys lining up for free vaccinations. “We still focus on sex as the responsibility of the woman,” she says.