Estrogen had been around since the 1930′s, although it didn’t get popular until the sixties after the publication of books such as Forever Feminine, by Dr. Robert Wilson.  Wilson touted HRT as a panacea and falsely claimed his support for these hormones was based on solid research.   As it turned out, Wilson’s book was paid for by the drug companies who manufactured HRT  link .

From the sixties through the nineties the FDA and the medical community allowed the ever widening use of these drugs, not only as a remedy for features of menopause such as hot flashes and night sweats but also  supposedly for prevention of diseases such as breast cancer, heart disease, stroke, and dementia.  Their recommendations were based on a combination of very poorly designed research and outright fraud. (For a thorough history of HRT, see Rothenberg at link)

Finally, in 1991, the Federal Government got involved.   The Women’s Health Initiative (WHI) was launched by the National Institute of Health (NIH) and began a randomized, double-blind, long term clinical trial to study the effects of HRT.  In 2002 the WHI stopped its research on HRT, after finding it significantly increased the incidence of breast cancer, strokes, and dementia, and blood clots. When  the  results of this clinical trial were released, millions of women stopped taking HRT.  Profits plummeted.

But WHI findings didn’t stop Wyeth Pharmaceuticals.  The primary beneficiary of HRT continued to use time-tested methods designed to undermine science.   Prior to 2002, Wyeth had paid off well-known researchers to  put their names on papers actually written by a company called DesignWrite. link After 2002, Wyeth and other drug companies went into the University of Wisconsin to promote HRT through “education.” link Along with other drug companies, Wyeth funded front groups like the North American Menopause Society.  Phony research, phony University programs, phony medical front groups.

So it’s not too surprising that people have found the research on HRT confusing.  That was the whole idea.  It may never be possible to determine how much of the “research” that is out there is simply poor design and how much is outright fraud.

Interestingly, there is one financially powerful private group that has the same interests as the women being offered these drugs, the insurers of pharmaceuticals. They are not at all confused.  The conclusion of the Risk Assessment at Lloyd’s of London:  take as little HRT as possible for as short a time as possible, except under special circumstances to be determined by your physician.  They estimate that use of HRT by women aged 50 to 64 in the UK over the past decade has resulted in an additional 20,000 breast cancers.  link With population five times larger than the UK the figure would be approximately 100,000 for the US.   And we haven’t even starting talking about blood clots, strokes, dementia….

One of the ironies of the entire HRT debacle is that these drugs don’t even do well for “symptoms” rightly or wrongly associated with menopause.  Researchers assessed  the quality of life of the WHI participants through questions about their general health, physical functioning,  pain, energy, social functioning, mental health, depression, sleep disturbances, sexual satisfaction, etc.; they found no clear benefits for those taking estrogen plus progestin on any of the quality of life measures.  Also for those women aged 50-54 who reported night sweats and hot flashes – common reasons for seeking hormone  treatment – the study also found no improvements in quality of life except a small improvement (1 point on a 20-point scale) in sleep disturbance. link

Wyeth is still making money on HRT, and has recently started raising its prices.  Perhaps they are simply illustrating the audacity of greed.  Or perhaps they are worried about the 5000 plus breast cancer lawsuits meandering lazily through the court system, the plaintiffs recently having been favored by a Supreme Court ruling in Wyeth vs. Levine  that weakens Wyeth’s ability to hide behind FDA approval of HRT.   link

Meanwhile back at the Women’s Health Initiative, the beat goes on.  Scientists continue to mine the data and to conduct new research.  Their most recent reasearch shows that the dementia caused by HRT is linked to atrophy of the frontal lobe and hippocampus, both of which are heavily involved with memory rather than  to lesions, which are usually caused by ministrokes.  link In 2008 a follow-up study showed that while the placebo group and HRT group had similar risk of cardiovascular disease in the three years after the study had been stopped, the HRT group group was at greater risk for both fatal and non-fatal cancers than the placebo group during that post-study period. link It’s important to remember that at the time of WHI, Big Pharma recommended that women stay on HRT indefinitely, and some women took it for decades.

Unlike the thalidomide scandal, which resulted in a strengthening of the FDA, the HRT scandal left the control of drugs just the way it was before the disaster.  Perhaps because of the insidious nature of HRT damage.  Perhaps because of the power of the pharmaceuticals.  Who knows?    To this day very few drugs out there have been tested for their long-term effectiveness, even though the WHI demonstrated that such studies can easily find willing co-operative participants.   Studies like the WHI can prevent great public health tragedies, but they always risk reducing the profits of the drug industry.

Basically, drug companies continue to favor advertising over science.  They would rather hype drugs than study them.   Friends of Big Pharma will no doubt recommend that everyone “accentuate the positive, eliminate the negative…”   Look at the wonders that drugs have produced!  This logic is somewhat lacking; removing damaging drugs from the market does not keep people from using beneficial ones.  In fact, good research can encourage people to take effective medications.  But it won’t necessarily lead to more profits.

As one of the wealthiest industries in this country, Big Pharma has plenty of money to develop new drugs.  But they are a lot like the bonus guys at AIG, who implied that if they didn’t get their bonuses, they would bring down the whole financial system.  The guys a big pharma say that if they aren’t allowed to put bad drugs on the market, they’ll stop looking for the cure to cancer.  Actually, if they need to scare up some money to develop some beneficial drugs, they should consider raiding the salaries they so generously bestow on their CEOs.

One major way to reduce health care costs is to get useless and harmful drugs out of circulation altogether, or extremely limited in their use.  Until the government’s support of science is strengthened against the powerful drug industry, it will be difficult, if not impossible to bring down the drug portion of health care costs.  Strengthening government involvement in drug testing would be a tremendous help in developing health care that is based on reason rather than hype.  Of course, this movement to science-based drugs would accelerate rapidly under a public option, and  Big Pharma can be counted on the fight the public option with all its might.