HRT (Hormone Replacement Therapy) In The News Again!

Back on Feb. 10, 2008 we reported (Health: BHRT vs HRT - Wyeth Pharm and the FDA vs Common Sense) on an excellent article written by William Campbell Douglass II, MD titled: FDA tries to limit safe HRT options. One of Dr. Douglass’ respected colleagues, Jenny Thompson has a bone to pick with the FDA over studies done on Hormone Replacement Therapy that’ll have you scratching your head as you wonder just who’s side the FDA is on: the citizens of the USA, or the huge pharmaceutical companies.

Take a few minutes and read both articles - it’s information you should know.

Red Flags

Dear Reader,

Nearly six years ago we found out that it increases your chances of developing several extremely dangerous health risks. And again and again over those years, we’ve received further evidence of its obvious dangers. And yet all these years later the FDA still stands behind it, never once suggesting it might be taken off the market.

Of course, I’m talking about hormone replacement therapy (HRT), or more specifically, the combined use of estrogen plus progestin.

And last month, once again, we received “new results from the Women’s Health Initiative…” And once again the news was bad. And once again our government representatives put their best feel-good spin on the bad news.

It really would be laughable if it weren’t for the fact that millions of women who trusted and used combined HRT continue to be at high risk of cancer, stroke, and blood clots, even though they may have stopped using the therapy years ago.

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Keep that sunny side up
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The new study closely followed more than 15,000 women who participated in the original Women’s Health Initiative (WHI) estrogen-plus-progestin clinical trial, which was shut down for safety reasons in the summer of 2002. For an average of nearly two and a half years after the women discontinued their treatment, researchers examined each subject yearly.

I’ll spare you the complete details and go directly to the results: Even though treatment was stopped, women who had used the combined HRT for five years continued to have significantly higher risks of stroke, blood clots, and various cancers, including lung and breast tumors. Heart disease risk returned to normal levels.

Officials for the National Heart, Lung, and Blood Institute (NHLBI – a division of the NIH and the sponsor of the WHI) did their best to put a positive spin on this new train wreck. In an NIH News report, NHLBI director Elizabeth G. Nabel states, “The good news is that after women stop taking combination hormone therapy, their risk of heart disease appears to decrease.”

That’s it. That’s the best she’s got: heart disease appears to decrease. But she’s not saying the subjects actually enjoyed a reduced risk compared to the average woman, just that their risk is not as high as it was when HRT use boosted their risk.

Also in the NIH News report, NHLBI official Michael S. Lauer, M.D., says it’s reassuring that “the risks for stroke and blood clots did not grow after the women stopped taking hormones.”

Again – amazingly – that’s the best he’s got: When the women stopped taking combined HRT, their risks remained high but didn’t go UP.

I guess in HRT world, that’s cause for celebration.

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Selling it short
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Believe it or not, after this fresh bad news, and after years of evidence that this therapy is quite dangerous beyond ANY shadow of a doubt, the FDA continues to timidly promote HRT use.

From the NIH News report: “The FDA recommends that hormone therapy never be used to prevent heart disease, and, when hormone therapy is used for menopausal symptoms, it should only be taken at the smallest dose and for the shortest time possible.”

Really – THAT’S their recommendation! Wouldn’t the shortest time possible be just one dose? Is this the FDA’s subtle way of telling women that after a single dose – “the shortest time possible” – they’re basically on their own?

And why should women use it “for the shortest time possible”? Here’s a clue from an Associated Press report about the original WHI trial: “Heart risks during the study were highest soon after women started taking hormones.”

It’s infuriating! The FDA is fully aware of these risks, and yet HRT continues to get a free pass. The least they could do is put a skull and crossbones on the packaging.

…and another thing

Any woman who’s ever suspected that her husband has a “selective” hearing problem will probably like this one.

The FDA’s Adverse Event Reporting System (AERS) has received 113 reports of sudden hearing loss linked to use of PDE5 inhibitors.

PDE5 inhibitor drugs treat erectile dysfunction.

An investigation into these reports of hearing loss – detailed in the Winter 2008 issue of the FDA Drug Safety Newsletter – notes that in 84 cases, hearing loss was not reliably linked to PDE5 inhibitor use.

So women, if you husband uses a PDE5 inhibitor and then later has a sudden inability to hear a single word you’re saying, there’s a 3 in 4 chance he’s totally faking it.

To Your Good Health,

Jenny Thompson

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