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DRUG BUST by Alan Cassels
For many people, it has taken a long time to come to believe that the Earth is round.
Sometimes, we are so connected with a theory and so personally invested in an idea, that even when it is decisively proved wrong, we just can’t bring ourselves to believe the new thing.
In medicine, theories about how to treat certain conditions or diseases flourish and are difficult to eradicate, even when they are inarguably proved to be overwhelmingly bad for us. Most of us are “Flat Earthers” about a variety of things that are trivial and harmless, but sometimes those outmoded ideas continue to inhabit the beliefs and perceptions of health professionals, whose recommendations may mean the difference between life and death for their patients.
On July 9, 2002, millions of patients and physicians around the world woke to the news that the United States National Institutes of Health had just halted a major clinical trial. In news reports picked up around the world, the NIH warned that a type of hormone replacement therapy (HRT) – a combination of estrogen and progestin – used by millions of women around the world was causing them more harm than good.
For hormones, this was the day the music died. Prescribed to more than seven million post-menopausal, North American women as a standard treatment for menopausal symptoms, and increasingly pushed for everything from heart attacks to osteoporosis prevention, this was also the day the Earth stopped being flat.
Called the Women’s Health Initiative (WHI), the study found that the combined drugs caused increases in breast cancer, heart attacks, strokes and blood clots. Although the risk to an individual woman was small, the huge number of women taking these drugs meant that the preventable death and disability measured across the globe was intolerably high.
In terms of the sheer number of women in the study (more than 16,000) and the pure scientific firepower the WHI was able to employ, it was probably one of the most influential and rigorous studies ever conducted in the world. Long-term, randomized and a controlled clinical trial – the “gold standard” in research terms – it was one of the largest prevention studies of its kind.
While the short-term effectiveness of treating menopausal symptoms with hormones was already established, the preventative benefits of taking estrogen replacement therapy (ERT) and hormone replacement therapy (HRT) for the long term was still a guess. The prevention theory was no doubt hyped by drug manufacturers and embraced by physicians, and more than four decades of use had many people believing these drugs prevented heart disease, colon cancer, Alzheimer’s, urinary incontinence and broken bones due to osteoporosis, as well as being hailed for improving the skin and reducing wrinkles.
Some have called the widespread popularity of hormone replacement therapy a “triumph of marketing and advertising over science.”
Yet even after this definitive study, there is evidence that Flat Earthers are still in our midst four years later, and HRT is still being promoted far beyond what the safety data would suggest. Sadly, the strongest proponents of its use are among those professionals, of whom many women trust the most on health issues: obstetricians and gynecologists.
In February 2006, a booklet and web resource called The Journalist’s Menopause Handbook: A Companion Guide to the Society of Obstetricians and Gynaecologists of Canada Menopause Consensus Report was launched. (See www.sogc.org/media/pdf/advisories/Menopause-journalists-guide_e.pdf)
Does this booklet debunk the flat-Earth beliefs of those wishing to promote continued pharmaceutical enhancement of women’s midlife? Suffice to say the Menopause Handbook, “made possible through an unrestricted educational grant from Wyeth Canada,” actually does the opposite, and confirms that the Earth is, well, flattish. Do I have to point out that there is no company on the planet (either flat or round, for that matter), which has more richly capitalized on the pharmaceutical treatment of menopausal women than Wyeth?
The goal of this Menopause Handbook is laudatory enough, and it does well to try to inform journalists about menopause (including helpful lifestyle advice). Much of it is drawn from the 2006 Menopause Consensus Report, prepared to “… provide guidance to health-care professionals to better understand menopause and treat patients in accordance with the most current clinical evidence.”
The nine recommendations in the Menopause Consensus Report concerning “symptomatic treatment” are worth repeating:
1. Healthcare providers should offer hormone therapy (ET/estrogen-progestin therapy) as the most effective therapy for the medical management of menopausal symptoms.
2. The primary indication for hormone therapy (HT) should be for the management of moderate to severe menopausal symptoms.
3. HT should be prescribed at the lowest effective dose, although the long-term risk/benefit ratio of lower dose HT has not been demonstrated.
4. HT should be prescribed for the appropriate duration to achieve treatment goals, while taking into consideration risks and benefits and the woman’s quality of life.
5. HT may be prescribed for an extended period, following proper counselling, if a woman decides that the benefits outweigh the risks. Periodic re-evaluation is strongly recommended.
6. Either progestins alone or low-dose oral contraceptives may be offered as alternatives for the relief of menopausal symptoms, especially during the transition phase.
7. Non-hormonal prescription therapies, including antidepressant agents gabapentine, clonidine and bellergal, may be prescribed as alternatives to HT to reduce vasomotor symptoms.
8.Healthcare providers may offer identified complementary and alternative medicine with demonstrated efficacy for mild menopausal symptoms.
9. Complementary and alternative medicine, including black cohosh, red clover-derived isoflavone and vitamin E may be recommended for the reduction of mild vasomotor symptoms. Long-term efficacy and safety data are still lacking.
I would summarize these recommendations in one sentence:
To relieve your menopausal symptoms, use hormones for as long as required, while balancing the risks and benefits. Try other pills if you like, but steer away from alternatives because we can’t say for sure how helpful they are.
The question then comes to this: how does the average woman actually learn about balancing risks and benefits? Unfortunately, the guide doesn’t seem to have much room for dwelling on the risk/benefit ratio; nor does it provide many numbers to help women judge what that ratio might be. To find how often adverse effects related to these drugs occur, you need to return to the results of the WHI study. If you gave the treatment to 10,000 women, (similar to the women enrolled in the WHI study), it would cause these types of events (vs. placebo):
• 29 percent increased risk for coronary heart disease: 37 vs. 30 events: 7 more events annually
• 41 percent increased risk for stroke: 29 vs. 21 events: 8 more events annually
• 111 percent increased risk for venous thrombosis (blood clots) 34 vs. 16 events: 18 more events annually
• 26 percent increased risk for breast cancer: 38 vs. 30 events: 8 more events annually
• 37 percent decreased risk for colon cancer: 10 vs. 16 events: 6 fewer events annually
• 34 percent decreased risk for hip fracture: 10 vs. 15 events: 5 fewer events annually
The study concluded with the following claim: “… overall health risks exceeded benefits,” meaning that you shouldn’t be using these drugs to prevent chronic diseases, such as heart disease, blood clots or strokes because rather than preventing those types of nasties, they cause them.
You find no such doom and gloom in the Journalist’s Menopause Handbook.
What does the Handbook say, for example, about the risk of stroke? It notes that healthcare providers should not initiate or continue HT for the sole purpose of preventing CVD (coronary artery disease and stroke). Fair enough, but that’s almost like saying that perhaps the Earth is flatter than you may believe. The word “clots, as in “blood clots to the legs or lungs” is not even mentioned in the document, stating only: “Healthcare providers should abstain from prescribing HT in women at high risk for venous thromboembolic disease.”
While other major omissions are equally mystifying, I would agree with one statement in the Handbook. According to the authors, the media does have a “… critical role in informing and educating Canadians about important health issues.” Sadly, they are not going to get much information following the trail of these “Flat Earthers.”
Canadians have a very strong interest in new advances in medicine and new discoveries about older medicines. Pharmaceutical manufacturers, however, who are accountable to shareholders, are interested in ensuring that sales are not jeopardized when new information arises about their products.
Excessive hype and/or fear about specific drugs can only be prevented by accurate and unbiased drug reporting in professional journals, information releases and in the mainstream press. The Journalist’s Menopause Handbook proves that if we allow health information to be interpreted by those who still believe the earth is flat, we do so at our own peril.
I don’t scorn the Flat Earthers. I am embarrassed for them. I also pity the women, who are following advice that has been dressed up by a professional society so invested in its own outmoded theories, that it can’t see the evidence for what it is. Shame on you.
Only time will tell how much harm they continue to cause women by maintaining that the Earth can’t be that round.
Alan Cassels is co-author of Selling Sickness: How the World’s Biggest Pharmaceutical Companies Are Turning Us All Into Patients, and a drug policy researcher at the University of Victoria. He is also the founder of Media Doctor Canada www.mediadoctor.ca/, which evaluates reporting of medical treatments in Canada’s media.
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