Really quick – how many of you are taking any kind of prescription or over-the-counter medication right now? If you’re a woman, there’s a good chance you’re overdosing. And depending on the medicine, guys, you may be at risk, as well.
A few years ago, the Food and Drug Administration (FDA) announced that women taking the popular sleep drug, Ambien, should cut their dose by half. It became the first and only drug in America that has different doses for men versus women.
As 60 Minutes pointed out in their coverage of this story, scientists are beginning to realize that drugs work differently in women than they do in men, and those differences could represent a bigger challenge to our confidence in pharmaceutical science than even side effects or adverse events.
In the case of Ambien, it turns out that women metabolize the drug so differently, than men that women may have significant “hangover” effects the following morning – effects that may impair driving abilities.
In essence, the women have “overdosed”.
With Ambien, a woman may have a 45% higher level of the drug in her system than a man would. Given the fact that Ambien has been on the market 20 years and was prescribed over 40 million times just last year, the number of times overdosing may have occurred is staggering.
It’s not just Ambien.
Specific differences in how the sexes metabolize drugs have been pointed out with aspirin and pain medication, and differences in liver enzymes and brain metabolism have also been discovered. The differences have caused some scientists to suggest that all pharmaceutical medicines need to be re-studied on the basis of sex differences, and dosing needs to be adjusted for all medicines.
All of them.
Imagine how long it would take to go back and re-examine every single drug that is currently on the market. Nobody seems to have a specific number of drugs that are approved right now, but it is estimated that there are over 100,000. Each drug takes years to study. Can you imagine how long this would take?
The impracticality of the task may be one reason that the FDA has decided not to even attempt a comprehensive review. This leaves us with only one drug out of over 100,000 that actually has a gender-adjusted dose and no guidance whatsoever on how to adjust dosing on the other 99,999 drugs.
Dr. Sandra Kweder, the former deputy director of the FDA’s office of new drugs said that for decades, their scientists never believed that men and women were all that different except for things like breast and ovarian health, and obvious hormonal differences. Otherwise, they’ve had a paradigm that said, “We’re dealing with the same things, regardless of sex.”
What this means is that when drugs are being studied, little or no attention is being paid to how the drug affects men differently than women.
What’s more, it seems that most drugs have been studied in men. The same 60 Minutes story uncovered a GAO report showing that of all the drugs withdrawn from the market from 1997 to 2001, “80% posed greater health risks for women than for men.”
And even when men and women are both included in drug studies, there is rarely any analysis showing the different effects in the sexes.
When there is sex-specific analysis on drugs, the results can be profound.
The 60 Minutes story introduced Doris Taylor, who does stem cell research at Texas Heart Institute. When she gave female stem cells to male animals, the male animals got better. When she gave male stem cells to female animals, the reverse happened; the female animals got worse. Taylor admits that before this experiment, she never dreamed that different results would occur on the basis of sex differences.
When Dr. Sandra Kweder was asked about all of this, she said that FDA has always used to very best science they have had at the time. Moving forward, however, they really cannot do anything about the plethora of drugs currently on the market, and sex-adjusted analyses for new drug approvals may not happen any time soon, either.
“Sophisticated science” was a term I heard during the 60 Minutes piece. It would be only too easy to be snide in questioning how “sophisticated” the science actually is when something as basic as sex differences has been entirely ignored in conventional Western medicine. Of all the things to miss, sex differences seems like it would be a basic thing worth considering.
“Sophisticated science” often doesn’t seem to be all that sophisticated sometimes when the mindsets, underlying philosophies, and glaring mistakes are brought to light.
To be sure, I believe that the scientists in this field represent a high IQ subset of the population. But IQ and discernment don’t necessarily always walk together. When they do, magic happens. When they don’t, astonishing miscues are apt to occur.
The 60 Minutes story is only pointing out one piece of the major differences I have with conventional medical philosophy. After spending time in the science and medicine worlds, I have severe concerns with much of what happens there, while happily acknowledging it when conventional medicine gets it right. I’m not so ideological that I can’t clearly see the blessings of living in a time when modern medicine’s benefits are so readily available. But because of the magnitude of problems conventional medicine potentially poses, I’m biased toward therapies and philosophies that appreciate the natural structure and function of the body, as well as the things that work with it’s natural function rather than things that battle against it.
It isn’t unfair to conventional medicine to point out some of its failures. You may have heard of the big Canadian study on mammograms that was recently published in the British Medical Journal. It said that women who regularly got mammograms died of breast cancer at the same rate as those who didn’t get tested. This is in direct contradiction to the advice women have gotten over the past 30 years.
The mammogram study stands alongside the revelation over the past few years that the PSA (Prostate Specific Antigen) test is a miserable failure as a diagnostic tool. Doug has a lot to say about this, so I’ll leave it to him. But I’ll simply say that the two most important sex-specific diagnostic tests conventional medicine has touted for decades, (mammograms and PSA), are both being found to be severely lacking.
What about over-the-counter drugs? Surely they’re safe, right?
Not so fast.
As of 3 years ago, the FDA was asking doctors to stop prescribing acetaminophen, (the active ingredient in Tylenol), in doses higher than 325 mg. The FDA said that there was overwhelming evidence that taking more than 325 mg at a time simply poses too much risk for liver damage. The National Institutes of Health says that acetaminophen poisoning is one of the most common poisonings reported throughout the world and that taking too much of this incredibly popular pain reliever can lead to massive liver failure or death.
And lest you think 325 mg of acetaminophen is a big dose, look on the label of any acetaminophen product you may have at home. The one I found contained 500 mg per capsule.
To show you how my mind thinks about this study, you need to know when this ingredient first hit the market. It was studied as far back as the 1880’s, and hit the market in 1950. So, we’re talking about a 67-year old drug that was only recently getting a dosing adjustment. That’s an awfully long time for people to have been taking something so common, which has had potentially severe liver effects all this time.
Am I glad that the FDA made the adjustment? You bet. And I say that as someone who has taken plenty of Tylenol over the years. When I’ve had pain and Tylenol knocked it out in a hurry, I’ve been extremely thankful for it. I’m also glad that the FDA is attempting to prevent a lot of unnecessary injury and death by making the adjustment.
Having said that, this article is pointing out a number of extremely troubling things about primary, high-profile drugs and procedures that have touched virtually every American adult some time in their lives. It speaks to how widespread the American medical philosophy impacts us, and how potentially dangerous or useless it can be at times.
Thankful when it’s helpful and life saving. Troubled when it isn’t.
What does this mean for average Americans? Well, the first thing we have to admit is that we’re all now stuck with this medical system in some form or another. We’re all called upon to pay into a medical system that the government now runs, and it’s made up exclusively of conventional American medicine. So, no matter how much some of us try to avoid conventional medicine except for emergencies or for marginal problems, a portion of our money will now be used to support and perpetuate a philosophy of health that doesn’t even realize men and women are different.
Secondly, these stories and studies highlight some of the reasons why I’m a natural health guy first. I’ve “been there, done that” with conventional medicine. As a health philosophy, it just doesn’t do it for me. I believe that our body/mind/spirit works together. I believe we’re designed a specific way, and that the things we put into our body/mind/spirit must work in harmony with that design to function at it’s best. I like having as few side effects as possible. I like it when the diet, exercise, supplements, thoughts, and prayers do me nothing but good. I like high rewards with low risks. This is why I love natural health and only use conventional medicine when I have to.
By all means, do what you’re led to do with your health. Utilize the expertise of professionals across a number of health disciplines. Recognize the strengths and weaknesses of every system you’re attracted to.
And if at all possible, work in harmony with your body’s design instead of working against it.