Data Today, Better Tomorrow, yay!

Women's Health Initiative

Some of us are suckers for studies: clinical trials, focus groups, surveys – whatever promises to shed a little light on the human condition, or possibly make that condition a little better.

This writer is a hopeless volunteer.

I have had my knees examined by MRIs, perhaps studying why I still have the originals despite a long history of abuse. I have had blood drawn for a study of celiac disease by someone who came to the house as part of the deal but unfortunately was not trained to find veins without causing excruciating pain. I have filled out lengthy surveys about addictive behavior – which may include addiction to study-participation (though that was not among the category choices.)

Currently, I am proudest of being an original part of the Women’s Health Initiative, which launched in 1993 with more than 160,000 postmenopausal women including this writer. In 1993 this was a Very Big Deal: studies had been made for all sorts of things with all sorts of participants, but finally there was a study of WOMEN. It sought to discover links between cancer (imagine! Studying women and cancer!) medical protocols, diet and other factors. Being a congenital wimp, and knowing I wouldn’t change my diet or stick to other proscribed regimens, I just signed up for the control group… but still. Even we control groupies are useful.

Over the years, WHI has developed a huge amount of useful data, probably the most beneficial being the finding that (imagine! Studying women!) hormone replacement therapy was not the be-all and end-all we had originally thought, but actually not such a good idea. (Read all about it.)

WHI has published over a thousand articles, approved well over 300 ancillary studies, and twice conducted extension studies. Findings have been about links between age, daily activities, diet etc and things like body fat, omega oils, heart disease, endometrial cancer – there is a list of useful discoveries resulting from this one large and ever-growing study project that boggles the mind.

Some – though surely not all – of this data is collected through regular survey forms received every year by WHI participants in addition to the annual birthday cards that by now this writer accepts as a “Congratulations! Are you’re still alive?” greeting. They seek data about lifestyles and life changes along with the traditional general health issues – and sometimes make one wonder what the next findings may be. My personal favorite question was, “When you enter a room full of people, do you often imagine they are talking about you?”

Paranoia after mastectomy? Who knows.

It is fascinating to be on the questioning end of tomorrow’s answers. Next blog: The Brain Health Registry. Assuming my closely-watched brain is still functioning.

Drugs, Perils and Trust

Oh great. Now I’ve got to worry about lung cancer.

Recently released findings on hormone replacement therapy now show it nearly doubles the risk of dying of lung cancer for those women who followed this regimen. Already we’ve learned that HRT is linked to increases in breast cancer, heart disease, stroke and who knows what else. It’s giving me a headache.

Hormone replacement therapy was, some 30 or more years ago, generally accepted as being the be-all and end-all for postmenopausal women. No hot flashes! Limitless energy! Avoid cancer! Resist heart disease! Live long and prosper! That was more or less the message. My good physician, now long dead of drug-related causes himself but a wise and decent man he was, enlisted the aid of his nurse, who was also a friend of mine, to convince me to begin HRT. Addictable to anything that comes down the pike and resistant to drug-taking in general, I protested. But they and the general public belief that these drugs (estrogen and progestin) were the answer to every woman’s prayers, convinced me. I took them daily for years, then once weekly, when the formulae were perfected.

I quit in 2006 for the best of reasons: breast cancer.

I am absolutely certain my doctor wanted only the best for me. But I’m still somehow a little comforted now by the knowledge that Kaiser does not let drug company representatives meet with its physicians. Most of us trust our doctors. Some people whom they trusted convinced a lot of doctors, 30+ years ago, that HRT was a wonderfully promising regimen. Oh, doctors also read reports and journal articles, and listened to presentations, and early studies did indicate that HRT was a wonderful thing. I presume even the drug makers sincerely felt — hoped, at least — they were doing good. They had wives and mothers, after all. (Most people in those workplaces at the time were male, I suspect.) But maybe, just maybe, a few more studies would have been in order.

Now we’ve got studies. And a lot of interesting new information thanks to the Women’s Health Initiative. It was the first ever major effort to look at the most common causes of death, disability and poor quality of life in postmenopausal women. WHI was launched in 1991 and covered 161,808 generally healthy women; without yours truly they’d have only had 161,807. In the effort to help the WHI folks collect data on cardiovascular disease, cancer and osteoporosis, we made regular visits to designated clinics for 5 years, giving blood, getting weighed, filling out forms, answering questions. For another 10 years we filled out annual reports (and I think some participants did more; I was purely a control-group person because I didn’t want to alter my HRT regimen and knew I hadn’t enough will power to stick to some rigorous, data-producing diet.) A lot of us died along the way, thus the data. I remain a participant in a follow-up study that runs until 2010.

I await with interest the next release of findings. Some of the questions are along the lines of ‘On a scale of 1 to 10, how happy are you?’ so somebody’s watching for quality of life connections to things like exercise and marital status. And drugs. I know there are great things being done with drugs, but this profit margin business combined with what we keep finding out does give me pause. (I loved the survey question that asked whether, when I entered a room, I thought people were talking about me. There’s a story here.)

But whatever they’re finding out, it’s carefully done, covers a long period and a relatively huge bunch of women, and bless their hearts. Meanwhile, if you’re on HRT, you might want to talk to your doctor. What we didn’t know proved it could hurt us.