The latest controversy concerning HRT

September 24, 2010 9:59 AM

Ever since the Women's Health Initiative published data showing increased risk and little benefit with post-menopausal hormone replacement therapy it has become more controversial and the FDA now recommends using the lowest dose possible for the shortest time, if using it at all. Why was HRT so popular in the first place? It now appears one reason was that what appeared to be legitimate articles in peer reviewed journals were actually ghostwritten by drug companies.

The Public Library of Science and New York Times filed a lawsuit against Wyeth (now part of Pfizer), on behalf of 14,000 women who were misled about the risks and benefits of these drugs. As part of the discovery process they obtained 1500 documents detailing how Wyeth manipulated the views of physicians concerning these drugs. Last December the Times described these efforts. Now PLoS has published its interpretation of the documents with a particular emphasis on the fact that many articles about these drugs were not written by their putative authors, but were ghostwritten by researchers employed by Wyeth. PLoS has also made the documents unsealed in the lawsuit available for you to read for yourself. Found via Bad Science.

posted by TedW (22 comments total)

Oh drug companies, is there anyone's health they won't disregard for a profit?
posted by gottabefunky at 10:07 AM on September 24, 2010 [1 favorite]

Excellent post! My Mom developed blood clots on her lungs quite suddenly years ago, and when her first symptoms appeared (shortness of breath when just walking across the room) her primary care doctor told her over the phone that it was just anxiety because she was post-menopausal and getting older, etc. We took her to the ER later that day and luckily they immediately ran the proper tests that showed multiple blood clots on one lung. She was on complete bed rest in the hospital for one week, and when the attending doctor at that hospital found out that she'd been taking Premarin he pinpointed that as the probable cause for an otherwise healthy woman to suddenly develop such a serious condition.

I must admit, I was also brainwashed by all the advertising; I really never researched it thoroughly and just presumed that once a woman goes through menopause she requires HRT or something "bad" would happen (I am getting very close to that age and had a fear of waking up one morning looking like Yasser Arafat once I stopped producing estrogen.) My doctor has reassured me that when that time does come, there's nothing more I need to do than just go through it.
posted by Oriole Adams at 10:15 AM on September 24, 2010

I am skeptical of HRT, but I notice that the women in my family who have undergone it are in much better conditional than those who didn't. Anecdotal, but makes me consider it an option.
posted by melissam at 10:20 AM on September 24, 2010

I don't have time to write a full comment, but I'm not surprised that the articles were ghostwritten. Premarin was/is made from the urine of pregnant mares, and that industry itself is a pretty sad one with plenty of surplus foals. Just do a search...I'm sure plenty of people made money in this industry. There are a lot of legitimate PMU mare and foal rescues out there now. I was protesting these back in the 90s and people used to think I was crazy.
posted by Calzephyr at 10:25 AM on September 24, 2010

For more information on the marketing strategies of drug companies, the site PharmedOut (run in part by the author of the PLoS article, who was also a paid witness for them in the lawsuit) is an excellent resource.
posted by TedW at 10:27 AM on September 24, 2010

Y'know, I have no doubt that pharma companies were up to all sorts of shenanigans when it came to those articles and promoting HRT for everyone. That said, it's not exactly wonderful that people are now scared off by HRT. It's still very useful for treating symptoms of menopause, and if someone's life is made completely miserable, and they understand the pertinent risks (which are still relatively low if the HRT is used for a short period of time), it should still be out there for use. One figure mentioned to me was that being obese, drinking too much alcohol, and not getting exercise are each risk factors that pose much more risk in terms of breast cancer than a few years on HRT. As with anything, caveat emptor.
posted by greatgefilte at 10:36 AM on September 24, 2010

I am skeptical of HRT, but I notice that the women in my family who have undergone it are in much better conditional than those who didn't.

It doesn't take a conspiracy to convince people to use a product they really want, and that can potentially make a big difference in their lives. The drug company that made it was greedy to sell it, and the women who took it were greedy to hang on to their old selves. Without HRT, there is no minimizing the transformative power of menopause. You come out on the other side a different person. For women, once they're over the hump, it's the beginning of the best years of their lives. For the men in their lives, its time to lie down in the coffin.
posted by Faze at 10:42 AM on September 24, 2010

"For the men in their lives, its time to lie down in the coffin."

How so, Faze?
posted by the Real Dan at 10:50 AM on September 24, 2010

I wonder if we will hear the same thing fifteen years from now about men and testosterone, since that's the latest hormone replacement therapy push.
posted by adipocere at 10:52 AM on September 24, 2010

It doesn't take a conspiracy to convince people to use a product they really want, and that can potentially make a big difference in their lives. The drug company that made it was greedy to sell it, and the women who took it were greedy to hang on to their old selves. Without HRT, there is no minimizing the transformative power of menopause. You come out on the other side a different person. For women, once they're over the hump, it's the beginning of the best years of their lives. For the men in their lives, its time to lie down in the coffin.

Um, Faze, is everything okay at home?
posted by vitabellosi at 10:52 AM on September 24, 2010

As with anything, caveat emptor.

This is all well and good, unless the information available to the consumer is full of lies. How can we judge for ourselves what might be a good risk or a bad risk if the "evidence" we are presented with is bullshit?
posted by rtha at 11:06 AM on September 24, 2010 [1 favorite]

Do we get an apology from Oprah and Suzanne Summers now for spewing bullshit and potentially causing harm to their viewers with bullshit advice?
posted by spiderskull at 11:27 AM on September 24, 2010

I'm post-menopausal, as are many of my friends. Some of them have gone through a very unpleasant transition with hot flashes and other symptoms. HRT was popular because it stopped those symptoms, and because it does help maintain younger looks. But hardly anybody gasps in horror at my advanced decrepitude, so it must not be too horrible.

The US, and probably much of the rest of the world, is cheerfully allowing corporate interests to govern, more openly than ever. This is why it's a bad idea.
posted by theora55 at 11:31 AM on September 24, 2010

All they had to do was get Oprah to invite some quack onto her show to talk about how pretty it made them feel and people'd have demanded it anyway. No need for all the lying.
posted by shinybaum at 11:41 AM on September 24, 2010

The Public Library of Science and New York Times filed a lawsuit against Wyeth (now part of Pfizer), on behalf of 14,000 women who were misled about the risks and benefits of these drugs.

A very mild procedural nit to pick -- this was actually a motion filed by the Times and the PLOS as intervenors seeking to unseal documents submitted under a confidentiality order in one of the cases filed against Wyeth. It was not a lawsuit filed by the Times "on behalf of" the women. The Times' motion was successful, and the judge ordered the documents unsealed.
posted by yarly at 12:01 PM on September 24, 2010

I know more about this subject than you can possibly imagine.
posted by chrchr at 12:11 PM on September 24, 2010 [1 favorite]

For women, once they're over the hump, it's the beginning of the best years of their lives.

For the women in my family who didn't take it, the hump they went over was the dowager's hump. I really wouldn't want to take HRT, but the HRT women in my family who are in their 90s with great bodies and active love lives versus the non-HRT women who are hunched over and in retirement homes make me pause. But correlation doesn't equal causation I know...just things like the hump and vaginal atrophy are SCARY. I'm sorry, but not wanting these things isn't selfish, it's common sense.
posted by melissam at 12:25 PM on September 24, 2010 [1 favorite]

Methinks we seem a tad over-eager to search for someone to blame...

"Why was HRT so popular in the first place?"

Simple - Palliative care. It made women feel better, and let them substitute several years of wild swings in hormone levels (with the concomitant negative physical sensations and emotional lability), to a week or two of going cold turkey once their ovaries called it quits for good.
posted by pla at 3:55 PM on September 24, 2010

God, my mom tried to go without HRT for years and had hot flashes ever hour, night and day. She had used it for a few years and then when the negative side effects were being reported, she decided to stop taking it. She tried soy, she tried teas and all the other random crap people suggested to alleviate her symptoms. She was so miserable it was like a miracle for her when she finally decided to start taking it again. Now she gets the absolute minimum dose through a patch, and by the end of the week when it's time to replace it she starts getting flashes again. So while I can appreciate that these drugs were pushed pretty hard, it has made her life so much better. I don't know if her case is more extreme than others (maybe because she had a total hysterectomy in her 50s?), but I hope people aren't scared off if it's something they want to try.
posted by Mouse Army at 5:54 PM on September 24, 2010 [1 favorite]

This is all well and good, unless the information available to the consumer is full of lies. How can we judge for ourselves what might be a good risk or a bad risk if the "evidence" we are presented with is bullshit?

This is where we would traditionally say "Well, you should ask your doctor!" but of course if they're being swayed just as much as consumers, it's a bit of a thorny situation. There's no good answer; I don't think the average person is going to bone up on epidemiology and statistics just to get an answer to a medical question. And that really brings up something more fundamental: what's the proper relationship between epidemiology and the individual patient/consumer?

These studies, whether they're ghost-written or not, are designed to be exquisitely sensitive to risk (or protection from risk) that is statistically significant. Yet, if we're dealing with something like HRT and breast cancer, it's an increase of something like 8 cases per 10,000 patients per year of use. Statistically meaningful, and of course very important on a population scale, but to the individual patient, it's pretty much meaningless. If someone taking HRT does develop breast cancer, from what I understand it's nearly impossible to say it was because of the HRT rather than nature taking its usual course. (Note, this is very different from, say, a drug that has more immediate effects that recede when the drug is stopped. That could be the case for HRT and blood clots, or the new antipsychotics and weight gain/diabetes, though I have to say I'm not sure about the permanence of the metabolic side effects of the latter.)

It's tempting to be a little nihilistic and say that for such a small risk, if a treatment works for a person, they shouldn't be concerned about possible side effects 10-15 years down the road. On the other hand, if we want to look out for the health of the population, it's better to be cautious. Once again: no good answer.
posted by greatgefilte at 7:27 PM on September 24, 2010

In our practice, we encourage patients not to do HRT unless their symptoms are interfering in their daily lives. I recommend more natural methods first. I find that it really comes down to different levels of tolerance. My mother suffered from frequent hot flashes for almost a year, but tolerated it and is now hot flash free (and looking very good actually. There is something to be said for being healthy prior to menopause). There are many other ways to prevent bone loss after menopause, so this is not a great justification for HRT.
posted by janakf at 7:55 AM on September 25, 2010

Thanks for all your comments; I'm glad others find this subject worth talking about. As the post heads toward the bottom of the front page I have one observation I want to make. Most of the comments have focused on how the drug companies used the peer reviewed literature to minimize the risks associated with HRT (and they are significant enough that both the WHI studies were stopped early because of strokes and other complications in the treatment group). What seems more significant to me is that Wyeth also used ghostwritten articles to promote off-label uses for estrogen and progesterone such as preventing heart disease, wrinkles, loss of libido, memory loss, and so on. If their drug reps pushed HRT for these indications they would be in big trouble. By promoting these uses in the medical literature they immunized themselves from criminal prosecution.

(As an aside, off label uses of drugs are very common and not a bad thing. To use one example, morphine is the standard against which all painkillers are judged, yet it is not approved for pediatric use. Since it is a cheap, non-patented drug no manufacturer is likely to invest the money and time to get FDA approval for pediatric use, yet many people who take care of kids routinely give them morphine and are very comfortable with it.)
posted by TedW at 3:18 PM on September 26, 2010