ABC News reported  earlier this week that the U.S. Food and Drug Administration has been aware of reports of spontaneous fractures, but did not inform the public or doctors who prescribe bisphosphonates of the possible side effect.  An FDA spokesman explained to ABC News that they didn’t think it was necessary at this time.  However, today, the FDA announced  that it will indeed investigate the possibility of a link between long-term use of osteoporosis drugs and thigh bone fractures though, “at this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures,” the statement said.

Bisphosphonates are vital for women who are at high risk for Osteoporosis. According to the National Osteoporosis Foundation, half of all women over the age of 50 will break a bone due to osteoporosis and more than 20 percent who break a hip die within one year.   “For most people taking bisphosphonate medicines, the benefits outweigh the risks of these unusual but serious conditions that appear to be associated with them,” the NOF said in a written statement on their website.   “These medicines play an important role in stopping bone loss and preventing broken bones.”

Though bisphosphonates  are commonly prescribed — some argue that they are overprescribed for women with marginal bone loss, or osteopinia-- you should carefully consider the need for taking osteoporosis medicine if your doctor thinks you’re a good candidate for drug therapy.  If you’ve had the bone mineral density test, obtain a copy of the report and go to this website for an explanation that will help you understand what the results mean. Then review the findings with your doctor and ask questions.

The appeals court said “the evidence presented could allow a jury to find or infer that Wyeth was guilty of malicious conduct.”  According to the news report, Pfizer’s lawyers argued that the plaintiff received ample warning about the cancer risks tied to the company’s Prempro and Premarin drugs and chose to continue using them.

“Our results indicate that improved quality of life can be added to the list of exercise benefits and that these improvements are dose dependent and independent of weight loss, at least among people similar to this study’s sample,” Corby K. Martin, PhD, from Louisiana State University System, in Baton Rouge, and colleagues write.

The study was published in Archives of Internal Medicine, a bi-weekly, international peer-reviewed journal.

There’s news this week about a new, hormone-free treatment for menopause-related hot flashes and night sweats.  It’s called Pristiq, and it was originally approved by the FDA last year as a remedy for depression.  The agency just gave the green light to Wyeth, the drugmaker, to also market it as a safe solution for women experiencing moderate to severe hot flashes.  Is this welcome news? I decided to “double-click” on this story to see if this falls under the category of “it’s too good to be true.”

First, there’s skepticism among some physicians that there’s nothing new about Pristiq. It’s a modified version of Wyeth’s earlier anti-depressant drug, Effexor XR, whose patent expired last year.  “Every patient who takes Effexor produces Pristiq in their own body, at no additional charge,” said Dr. Daniel Carlat, a psychiatrist who wrote about Pristiq on his personal blog last year.

Second,  I wonder about the integrity of any research that is conducted and/or funded by the manufacturer.  In this case, a 26-week double-blind, placebo controlled study, which was “supported in part” by Wyeth Research, was led by David Archer, MD, a professor of obstetrics and gynecology at Eastern Virginia Medical School in Norfolk and four additional physician-researchers.  As described on the school’s website, Dr. Archer is past president and a former board member of the North American Menopause Society (NAMS), which is largely funded by Wyeth (and advocates the use of conjugated hormones made by Wyeth).  He is a consultant for Wyeth Research and has received grants and honoraria from the Wyeth Speakers Bureau. And by the way, the four other physicians who conducted the study are either consultants for, or employees of Wyeth Research.  One of them, Dr. Ginger D. Constantine co-authored an article praising Wyeth entitled “Wyeth: The Leader in Women’s Health – Yesterday, Today and Tomorrow” that appeared in a publication for the American Society for Reproductive Medicine (9/2004).

Dr. Archer also stated, a full year before the FDA approved Pristiq as a treatment for menopausal hot flashes, that “Pristiq is going to fill a needed void. For women who can’t take estrogens… it should be made available.”  Was he speaking as a researcher or promoter for Wyeth’s drug?

Another study that monitored 689 women on Pristiq or placebo over a 12 month period of time was led by Dr. Margery Gass, a professor of obstetrics and gynecology at the University of Cincinnati.  Dr. Gass has disclosed that she is a consultant and receives funding from Wyeth.

Oddly, the only study that concluded that Pristiq did not work much better than placebo and was inferior to a hot-flash-relieving drug not available in the U.S. was authored by a researcher who works for Wyeth, Dr. James Pickar.

So, what to make of all of this?  Know that Pristiq is NOT a new drug – it was approved for the treatment of depression one year ago.  While this class of drugs can correct the neurotransmitter imbalances that cause hot flashes and night sweats in some menopausal women, they can have side effects such as sexual dysfunction, sleep disorders, dry mouth, and nausea.

Also know that research studies tend to reach conclusions that the funders – in this case, Wyeth – are seeking.  From what I’ve been able to read on the web,  every physician-researcher involved with Pristiq has had ties to the company.  The FDA doesn’t seem to mind but if I were in charge of the health and welfare of this country’s population, I would insist on unbiased, third-party research.  Is there such a thing?

As someone who swallows six multi-vitamin tabs every day, I was dismayed to read that “Multivitamin Use May Offer No Benefit in Postmenopausal Women,” the headline of a report that was published this week in the Archives of Internal Medicine.  Does that mean everyone, myself included, should stop taking a multi-vitamin?

The short answer appears to be no, or at least not necessarily.  Though the study concluded there really is no reason to take a multivitamin if you have an adequate diet, the study’s authors acknowledge that the women participating in the study were not typical of the general public.  At least 80 percent finished high school, 40 percent had a college degree or higher, and overall, they had better health habits than the public at large.   So they concluded that multivitamin use “just doesn’t seem to make that much of a difference in this population,” explained Dr. Sylvia Wassertheil-Smoller, the principal investigator of the WHI study, at Albert Einstein College of Medicine.

So that still leaves me and others with the question – do we eat well enough that we can do without multivitamins?  In my opinion,  if a woman is dieting or exercising furiously to lose weight, or is too busy or stressed to prepare well-balanced meals, than she would likely benefit from a multivitamin supplement.

As the study’s authors noted, multivitamin use “confers no additional benefit but it also does no harm.” In other words, it can’t hurt.

There has been debate over whether this quick decline was due to women stopping the widely prescribed Prempro, Wyeth’s combination estrogen and progestin hormone therapy, which was used in the WHI study, or whether the decline coincided with better detection as more women had mammograms in the 1990s.

In this latest analysis of the medical records of women who participated in the study, researchers concluded that Prempro’s added breast-cancer risk fell quickly, within about two years, after women stopped taking hormone therapy.

You can read more details about this study in today’s Wall Street Journal Health column, which quotes two physicians;  Dr. Avrum Bluming, who has been critical of the WHI study said “the drop was too fast to attribute it to hormone use” alone.  The other, Dr. Rowan Chlebowski, the UCLA physician who led this most recent analysis, said, “this is the best data we have.”

The debate continues…

Update: (2/11/09)

Wyeth’s spokesperson, Gwendolyn Fisher, comments on this study:

“We don’t believe the article supports the theory that the decline in use of estrogen plus progesterone caused a one-time abrupt nationwide decline in breast cancer incidence. They don’t offer an explanation of why breast cancer rates remain stable today when HRT rates continue to decline.”

Statement from the International Menopause Society

“The decline in breast cancer rates started at least 3 years before the Women’s Health Initiative study was halted. Breast cancer takes years to develop and, to reach the stage where it is detectable, it takes at least a decade. If HRT use causes breast cancer, then the drop in breast cancer rates would not be seen for some time yet.”

Melinda Beck’s “Health Journal” column in today’s Wall Street Journal focuses on “The 7 Things You Should Know About Hormones.“  She tries to clarify the debate over bio-identical hormone replacement therapy by offering 7 facts about bio-identicals, some of which are, well, debatable such as: don’t trust saliva tests, and hormones from compounding pharmacies aren’t safer than conventional HRT.  I don’t know if those statements are true, but I do know that there is still principled debate on both sides.

Melinda Beck quotes a physician-spokeswoman representing the Endocrine Society who weighs in against bio-identicals: “women may be putting themselves at much higher levels of risk.”  I wish Ms. Beck would have pointed out that Wyeth Pharmaceuticals, the maker of Premarin and Prempro,  (the most widely prescribed hormones until the WHI study was prematurely stopped), is a Corporate Liaison Board member of The Endocrine Society and was a “Leadership Donor” in 2002, according to Compounding Facts.Org (written by an organization of compounding pharmacists).

That doesn’t negate the spokesperson’s statement.  A connection with Wyeth just colors the debate and makes us wonder, don’t you think?

The first global summit of  40 “menopause experts” convened last week to review the current evidence, risks and benefits of using hormone replacement therapy for women in early menopause. They concluded that HRT is indeed safe for healthy women entering menopause, despite what the 2002 government-sponsored WHI study showed.  They went so far to state that women should “have no fears” about its use.”  I don’t know about you, but I find that statement quite startling in light of all the research that has concluded that HRT poses a number of significant health risks. 

It’s worth reading the entire press statement published by the International Menopause Society, the summit’s sponsor, to judge for yourself the merits of their arguments.

To begin with, the panel concluded that the 2002 WHI study was “over interpreted and negatively slanted,” and that the study’s investigators failed to emphasize the data.  They added that “the results of the WHI…were prematurely released before the study was completed and before the results could be properly evaluated. As a result it is clear that the WHI showed that properly timed HRT is safe for healthy women in their early postmenopause and has major preventative effects against fractures. It reduces mortality and this may be, in large part, due to the prevention of heart disease.”

The summary statement lays out a list of perceptions vs. scientific data in four categories: cognition, breast, bone and heart disease & stroke.  Here’s a partial list of the evidence presented:

• HRT in women aged 50-59 does not increase risk of coronary heart disease in healthy women and may even decrease the risk in this age group.
• After five years’ use of combined estrogen and progestogen, there is a small increase in risk of breast cancer in North American women of about eight extra cases per 10,000 women per year.
• Overall, HRT is effective in the prevention of all osteoporosis-related fractures, even in patients at low risk of fracture. And, although no head-to-head studies have compared HRT to bisphosphonates in terms of fracture reduction, there is no evidence to suggest that bisphosphonates or any other antiresorptive therapy are superior to HRT.
• At present, there is no evidence of substantial cognitive decline across menopausal transition. However, many women experience cognitive difficulties in association with vasomotor symptoms, sleep disturbances and mood changes.

Unfortunately, this Global Summit meeting of experts was held “with the assistance of unrestricted educational grants” received from three pharmaceutical companies that manufacture and market hormones; Wyeth, Bayer-Schering and Novo Nordisk Femcare.  This diminishes, in my view, the value and integrity of the panel’s recommendations and they unfortunately missed an opportunity to move the HRT debate forward despite the research, analysis and debate that took place.

The stated aim of the summit was “to narrow the gap between the evidence and its perception by health professionals and the lay public.” If they really want to allay women’s concerns about HRT, and set the record straight with new thinking, the International Menopause Society should cut their ties with companies that have a financial stake in the debate’s outcome.

Do you agree that the integrity of the panel’s findings were compromised by its association with the three pharmaceutical companies? Did their recommendations convince you that it’s safe to take hormones?  I hope you’ll share your views here.

I always suspected that biphosphonate drugs like Fosamax, Actonel, Boniva,  which are prescribed to women who show signs of osteoporosis, or bone-thinning, fell under the “too good to be true” category. 

Though this class of drugs has been used for more than thirty years, I first heard about Fosamax a few years ago when a friend of mine, who showed signs of osteoporosis while in her early 40s, said that the drug not only stopped her bone loss but also improved bone density after taking it for only two years.  Naturally when my dexa scan showed osteopinia - a pre-osteoporosis condition- I readily accepted my physician’s recommendation to begin a treatment of Fosamax, which is the most widely used drug treatment for osteoporosis. 

However, within just the last few weeks, there have been three published studies that raise concerns about this class of drugs. One, from the University of Washington, concluded that women who have used Fosamax are nearly twice as likely to develop the most common kind of chronically irregular heartbeat (atrial fibrillation) than are those who have never used it.  You can read the press release about the research findings here.

A second research team at the University of Southern California School of Dentistry has concluded that biphosphonate drugs are causing a jaw tissue infection – called osteonecrosis –  in some patients.  The researchers say that microbial biofilms, a mix of bacteria and sticky extracellular material, are the culprit.  You can read about this research here.

In a third study, Canadian researchers at The University of British Columbia and Vancouver Coastal Health Research Institute concluded that use of biphosphonates nearly triples the risk of developing bone necrosis, a condition that can lead to “incapacitating pain.”  The study was based on the health records of 88,000 Quebec residents from 1996-2003 and researchers say it is the largest study examining the relationship between bone necrosis and bisphonates. You can read about this study here.  

The FDA did issue an alert about bisphosphonates that highlighted “the possibility of severe and sometimes incapacitating bone, joint and/or muscle pain” in patients taking the drugs.

If you’ve been diagnosed with osteopinia or osteoporosis, and you’re concerned about taking this type of drug, be sure to read Dr. Pat Yarberry Allen’s column,  “10 ways to improve bone health without drugs”   found on the  Women’s Voices for Change website.

A study was conducted by researchers at the University of Arizona College of Nursing  to determine the most common as well as the most severe symptoms of menopause.   The findings?

• Sleep difficulty was cited (by 95% of participants) as the most common and the most severe symptom experienced.
• Forgetfulness was right up there with 92%
• Irritability was experienced by 87%  of study participants
• 85% experienced night sweats  

“Although the severity of these problems changed as the women progressed through the early stage of menopause, the sleep difficulties the women reported remained fairly constant,” study leader Judith Berg explained.

The study was published in the Journal of Clinical Nursing. You can see the published abstract here.

What about you? How would you rank the menopausal symptoms that you’ve experienced?