Sex and the Drug Trade

Last night 60 Minutes reported on the gender differences in drug testing. This will probably not surprise you: Most of pharmaceutical drug testing is done on males.  Not only human males but animals in testing are almost always males.  The recommendations and findings then are gender-oriented but not gender specific.  In other words, science defaults to how men’s bodys metabolize drugs and the FDA dosage recommendations are based on the male metabolism.

The reason? Women have “pesky” hormones that are erratic.  Men are, allegedly more stable biologically speaking.

All that has been turned on its ear thanks to Ambien.  A popular sleep medicine prescribed to more than 40 million people – men and women – per year.

Turns out the women have about 45% more of the drug left in their systems upon waking.  That affects driving.  And so the FDA in an unprecedented move required that dose recommendations be changed.  The recommendation now is to prescribe women half the amount prescribed to men.

It puzzles the heck of me why there has been this assumption in the science world: take away boobs and ovaries and men and women are the same under the skin. That was the basic rationale for experimenting almost exclusively on male subjects. Oh and the female hormone thing mucked up  their results.

It’s been known for sometime now that women experience heart attacks differently than men.  Our symptoms are different. Women are more likely than are men to have heart attack symptoms without chest pain, such as:

  • Neck, jaw, shoulder, upper back or abdominal discomfort.
  • Shortness of breath.
  • Nausea or vomiting.
  • Abdominal pain or “heartburn”
  • Sweating.
  • Lightheadedness or dizziness.
  • Unusual or unexplained fatigue.

In the 60 minutes report, they talked about stem research and how researchers wanted to track the stem cells so purposefully injected female stem cells into male rats and male stem cells into female rates.  And guess what they discovered?  The female stem cells worked better in removing plaque from arteries – a lot better. Men’s stem cells are less powerful. I guess pesky hormones aren’t so pesky now.

The 60 Minutes report was a catalyst to some overdue proposed groundbreaking changes.  According to 60 Minutes:

“The FDA agrees that encouraging diversity is vital for biomedical research and for ensuring the health needs of patients across the demographic spectrum,” says Tara Goodin, a press representative for the FDA, “The agency is striving to develop a well-informed action plan for improving data collection, analysis and communication about demographic subgroups in clinical trials of FDA-regulated human medical products.”

The FDA knew that women metabolized the Ambien differently.  It was right there in the report from 20 years ago.  They just didn’t think it mattered.  Until it was tied to traffic safety.

We can’t go backwards.  And neither will the FDA when it comes to re-scrutinizing all the approved drugs to see if gender makes a difference in dosages.  The FDA rep did say docs should always prescribe the lowest dose of any drug to see if it’s effective.

Your health is mostly in your hands. Be proactive. Check in with your doc and ask about dosages and any side effects that you should be aware of.  And thank you 60 Minutes for doing what good journalism is meant to do – report the facts to create positive change in the world we live in.

Watch the 60 Minutes report.

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