[WARNING!] Big pharma safety trials leave out key groups

As coronavirus vaccination efforts continue to unfold around the country, government experts are encouraging pregnant and lactating women everywhere to feel confident about getting vaccinated.  

But all of the large-scale clinical trials testing vaccine safety and effectiveness intentionally excluded pregnant and lactating women. And so, the only real data we have on this population involved 84 pregnant women, 31 breastfeeding women, and 16 women who weren’t pregnant or breastfeeding as a control group. 

In my view, that scant data is far from enough evidence to make such a claim or recommendation 

Furthermore—it hints at much bigger problem 

Drug makers purposefully exclude “vulnerable” populations 

Big pharma has a long history of intentionally excluding “vulnerable” populations—such as pregnant women or older people—from clinical trials on their new drugs in development.  

Basically, they want to eliminate anyone who may not respond well to the new drug and who may potentially thwart the drug’s approval by the Food and Drug Administration (FDA).  

But then, after the new drug gains FDA approval, big pharma turns right around to market it to these exact, excluded, and unstudied populations. 

Granted, part of the reason big pharma originally began excluding pregnant women from its drug trials probably has to do with what happened 70 years ago… 

As you may recall, a German drug company introduced thalidomide to the European market in 1957 to help pregnant women deal with morning sickness. But in Europe, it resulted in children born with serious birth defects. Thankfully, the FDA caught the problem before the drug hit the open market here in the U.S  

If we go back even farther, you may recall that doctors prescribed a synthetic form of estrogen called diethylstilbesterol (DES) to prevent miscarriages and premature births between 1938 and 1971. But 1953 study found that the drug showed no benefit. Nevertheless, it remained in use…even here in the U.S.  

Then, in 1971, study found that DES caused a rare vaginal cancer in girls born to mothers who had taken itSo, the FDA took the drug off the market. And by 1974, the federal government had begufunding screening for young women who had been exposed to DES, much like routine screenings conducted today for cervical cancer. 

These two horrific outcomes gave big pharma all the justification it needed to leave pregnant women (and other “vulnerable” populations) out of their clinical trials. It also caused most medical schools to revert back to the sensible, old adage that pregnant mothers shouldnt take any drugs. (Indeed, I was taught that basic rule back in my medical training in the 1970s. And recently, my daughter faithfully rejected all prescription and over-the-counter [OTC] drugs for the entire nine months of her pregnancy during the tumultuous year of 2020.) 

But today, things are different in one major way… 

There’s been an alarming increase in the number of pregnant women prescribed drugs, including a lot of psychiatric drugs for depression and anxiety. Yet, we still have very little clinical trial data on how these drugs affect pregnant women and their children. 

And that’s a very dangerous combination 

More pregnant women taking untested drugs 

Since pregnant women are excluded from most clinical trials, sometimes, the FDA doesn’t learn about a drug’s risk for mother and child until after they approve it and it comes onto the market. (We learn about it during a period called “post-marketing surveillance.”)   

In general, we do know that drugs taken earlier during pregnancy demonstrate risks of affecting the formation of organs and other body parts. And drugs taken later in pregnancy may affect brain development and birth weight, with potentially lifelong consequences. 

But, in my view, that’s insufficient data. And according to a study published in the journal Obstetrics and Gynecology90 percent of drugs approved by the FDA between 1980 to 2000 had an “undetermined” potential to cause fetal malformations. The researchers concluded that, inadequate information is available for pregnant women and their physicians to decide whether the benefits exceed the risks for most drugs introduced during the study period.” 

Plus, here’s the kicker… 

Excluding pregnant and lactating mothers from clinical trials does not eliminate risk. It simply shifts the problem off the plate of big pharma and onto the plate of the treating physician…who may not realize the potential risks and how to deal with them.  (Remember, according to a survey by the American Medical Association, 90 percent of doctors say they don’t have time to read scientific journals.) 

Furthermore, treating physicians don’t have a choice to prescribe drugs to pregnant women when they experience acute high blood pressure or high blood sugar (an increasingly common scenario)They must treat these womenbut are forced to do it without clinical data or guidance 

In the end, I strongly urge you and your loved ones to be wary of taking any drugs—prescription and OTC—during pregnancy. Because as I explained in the March issue of my monthly Insiders’ Cures newsletter (“Spring cleaning for your mind, body, soul—and medicine cabinet), there are many effective, natural solutions to common health ailments. (Not yet a subscriber? Click here now!) 

And if taking a drug to treat a serious problem, such as diabetes, is necessary, then the treating physician or midwife should carefully monitor both the mother and the baby for any potential problems.  

Sources: 

Why are so few drugs tested for safety in pregnancy?” Undark, 10/1/2020. (undark.org/2020/09/30/drug-testing-safety-pregnancy/) 

“Pregnant women ‘didn’t have the data’ – until now: COVID-19 vaccines are safe and effective, even for babies, study shows.” USA Today, 3/28/21. (usatoday.com/story/news/health/2021/03/27/covid-19-pregnancy-vaccines-safe-protect-moms-babies-study/6979881002/) 


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