Paradox: Dangers of not testing drugs on pregnant women

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.

The result? A knowledge gap that’s putting both the woman and the fetus at greater risk, according to a recent paper in 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.

“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 women through research, not just from research,” bioethicist Carleigh Krubiner of Johns Hopkins University in Baltimore wrote in an accompanying commentary.

There are growing signs that shift may have started. Last year, international research ethics guidelines were updated to 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 removing pregnant 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.”

The initial idea 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 2012 study found 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 is designed to find out.

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,” Persaud told CBC Health. “Do they manage to obtain access to medications through the existing private and public programs?”

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

Original article by Kelly Crowe & CBC Health Unit, CBC News at:

Photo credit: Tero Vesalainen/Shutterstock

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