SECOND OPINION | Pregnancy paradox: Dangers of not testing drugs on pregnant women

Hello and happy Saturday! Here's our mid-summer roundup of eclectic and under-the-radar health and medical science news.

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Pregnant women can get sick. And women with illnesses do get pregnant. Yet most drugs have never been tested for their effects during pregnancy.

That's because pregnant women are usually excluded from drug trials because the risks are considered too great.

It's in the interest of the fetus that the woman is well. That's an important mind-shift that we need to make.-Indira van der Zande,University Medical Centre Utrecht

The result? A knowledge gap that's putting both the woman and the fetus at greater risk, according to a recentpaperin the BMJ Journal of Medical Ethics.

It's estimated that nine out of 10 women will take at least one prescription drug during pregnancy. Yet most of those drugs come with no instructions about how to prescribe them for pregnant women.

"For 97 per cent of the medications there is no evidence and the result of that is physicians must prescribe off-label medications" said Indira van der Zande of the University Medical Centre Utrecht in the Netherlands. "Also, the doctor or the woman herself might discontinue medically important medications during pregnancy."

Van der Zande examined the assumption that pregnant women are too vulnerable to be included in medical research. She concluded there is no reason to leave pregnant women out of drug trials. They are capable of giving informed consent, and they're also able to grant consent on behalf of their developing fetus.

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"The fears about the effects on the fetus are valid," van der Zande told CBC Health. "But not including pregnant women in studies is also harmful to the fetus."

It's in the interest of the fetus that the woman is well, she said, and "that's an important mind-shift that we need to make."

"There is a desperate need to shift the paradigm to protect pregnant womenthroughresearch, not justfromresearch," bioethicist Carleigh KrubinerofJohns Hopkins University in Baltimore wrote in an accompanyingcommentary.

There are growing signs that shift may havestarted. Last year, international research ethics guidelines wereupdatedto clarify the rules about the use of pregnant research subjects.

And in January, the U.S. government updated its policy for the protection of human subjects by removingpregnant women from the list of populations that are "potentially vulnerable to coercion or undue influence."

What happens when people get free prescription drugs?

Will they take the drugs? Will their health improve? Those are some of the questions a team of Canadian researchers is trying to answer with a unique clinical trial underway right now.

The idea for the study was born out of frustration when a group of downtown Toronto doctors discovered their patients couldn't afford the medicine they were prescribed.

"These people keep coming back with the same problems. They come back with blood pressure and diabetes that is not well controlled," said Dr. Nav Persaud, lead researcher and a family doctor at St. Michael's Hospital.

"Those visits where you talk about the fact that their blood pressure is still high are publicly funded, but the thing the person really needs the medication is not publicly funded, so they just keep coming back."

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The initialidea was to simply supply free drugs to the patients at St. Michael's Family Health Team.

"It became clear that this wasn't an issue that just our patients in inner-city Toronto faced," Persaud said. "There are literally millions of people across Canada who can't afford medications."

A 2012studyfound one in 10 Canadians can't afford the drugs their doctors prescribe. But so far there is limited research about what happens if those same people have improved access to the drugs they need.That's what this new trial isdesignedto find out.

It's sad and surprising in a high-income country like Canada that we can do a study like this, that we could find 786 people who report they didn't take a medication because they couldn't afford it.- Dr. Nav Persaud,St.Michael's Hospital

The researchers have recruited people, from both rural and urban areas, who can't afford their drugs. Half are receiving medicine free. The other half the control group are not. In other words, they still can't afford the drugs they're prescribed.

"We'll be able to see what happens to those people over time,"Persaudtold CBC Health."Do they manage to obtain access to medications through the existing private and public programs?"

There are 140medicines being provided for free, including drugs for high blood pressure, diabetes, HIV, hypothyroidism, rheumatoid arthritis, pneumonia, ear infectionsand gout.

No cancer treatments are included. Nor are any drugs that are provided in hospitals because those medications are already publicly funded.

The researchers are measuring blood pressure and the control of diabetes, HIV and other chronic diseases to gather data on the effects of providing free prescription drugs.

"The most common question I get is, is it ethical to provide some people with medicine and not others, even though all of them say they can't afford their drugs?" Persaud said, adding the study has had ethics approval from St. Michael's Hospital.

"It's sad and surprising in a high-income country like Canada that we can do a study like this, that we could find 786 people who report they didn't take a medication because they couldn't afford it."

A Canadian moment in medical history

As part of our summer Second Opinion series, we're featuring great Canadian moments in medical history.

This week, meetDr. Mildred Vera Peters.

She began her research career in 1935, studying patients with Hodgkin's lymphoma at Toronto General Hospital.

When she published a study in 1950 showing that many patients with Hodgkin's could be cured if treated early with high-dose radiation, she faced skepticism from colleagues.

She faced more skepticism at Toronto's Princess Margaret Hospital in the 1970s when her research showed that not all women with early stage breast cancer needto have their breast removed. Instead, partial surgery and radiation could be just as effective.

Now, both of her ideas have become common clinical practice. She'screditedwith changing the management of both diseases.

Mildred Vera Peters died in 1993 at age 82.

These fascinating stories of discovery were selected from the Canadian Medical Hall of Fame, a medical history organization that began in 1994. Every year, six Canadians are inducted. There is a small exhibit hall in London, Ont., but executive director Lissa Foster told usthe real halllives online, with video features for the 125 laureates.

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