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?
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Hey Ladies, Do you recall that Wyeth is the drug manufacture who filed the complaint with the FDA against the compounding pharmacies about making false claims about the safety of BHRT, bioidential hormone replacement, which lead the FDA to issue warning letter to seven of the compounding pharmacies. Well, this drug was in the clinical trail process when they filed the complaint. After losing millions of dollar when the women’s initiative study was released, they came up with a new twist to market drugs to the estimated 50 million woman in menopause to recoup their losses. I would suggest you take a very close look at this new marketing campaign and bypass it. It is clear the FDA is in bed with the Wyeth. Once again, I will tell all of you to look at who is on the approval board for the FDA for these drugs. Don’t be surprised if you find those on the board working for companies like Wyeth.
Wow! Thanks for your input Sheila. I would like to know who is on the approval board of the FDA but always thought they were behind a virtual “firewall” unaccountable to anyone. See my blogpost from 1/21/08, in which I question if the FDA is looking out for Wyeth more than women.
During the extensive research I have done for an upcoming website, I studied and followed clinical trails for disease and conditions that I feel are directly linked to reproductive hormone imbalances. I was stunned to discover the most corrupt process I could ever have imagined. Did you know that Wyeth lost 2.2 billion dollar when the news came about about the derailment of the Women’s Initiative Study? The use of there HRT drugs decline by 67%.
The drugs that are market toward woman young and old for depression, psychiatric disorders, vaccinations and hormone replacement traditionally have very short trials. I often say that the drug manufacturer use woman’s bodies and minds for profit.
Let me give you a few examples. Let’s start with one of the most profitable drugs ever market toward woman. Yes it’s birth control pills. Did you know that the only study that was done on birth control pills was done in the mid 1950’s on a hand full of woman for Puerto Rico for three months. The Woman’s Initative Study was the first study ever done on hormone replacement (HRT). I often wonder why there is so much controversy regarding bioidentical hormone replacement (BHRT) when birth control pills, made up of synthetic hormones, are one of the most profitable drugs on the planet.
Up until recent years woman were not used in clinical trails. They did their studies on men, mice and monkeys.
About four years ago I happened on a conversation with a gentleman who identified himself as the CFO of the largest drug manufacture in the world. At the time of this meeting I was in a state of outrage over the suicidal deaths of teenagers as a result of antidepressed drugs that were never tested for their use. Did you know that individuals die during clinical trails. Do you think the drug manufactures actually provide this information during their approval process. The drug manufactures are well know for not reporting adverse affects that result in their trials. Back to my conversations. When I expressed by outrage to this gentlemen he told me something that I will never forget. He told me that drugs are manufactured to be useful for the majority of the population. He told me that the manufactures know that some people won’t do well on the drugs but that as long as the majority of people do well this was just part of the business. I asked him if his teenager had died as a result of taking an antidepressant who would he feel. He did not have an answer.
Often times when a drug is approved for one thing and it’s found during the clinical trail it also has benefits for other conditions the FDA will simply do a quick approval for the new found use. This is the case with Pristiq. The billion dollar question I want answered is this. Declining levels of reproductive hormones in midlife are know to cause an wide range of symptoms from mood swings to hot flashes, to weight gain, depression and so many others so what is this antidepressant really affecting.
Did you know that if you look at that small tightly wrapped piece of paper that comes with your prescription and unravel it you will find a copy of the results of the the clinical trail for the drug. Something else you will find is that for the majority of drugs that are tested the placebo results are as good as the result that individual have taking the drugs.
My suggestion to every woman is get your hormone levels checked by a physician who has taken the time to be retrained understanding the connection between symptoms and reproductive hormone levels. You save yourself the risk of being on drugs that have hundreds of side effect and I know from my own perimenopause nightmare that once you hormones are balanced you’ll feel like a million dollars.
Thanks Shelia for your comment. It’s common practice, I’m told, that when a pharmaceutical company loses a patent on a drug, they give it a new name with a new indication and voila! they have a new patent. That certainly seems to be the case with Pristiq. It’s my hope that this blog and comments like yours will motivate women to thoroughly research any drug that has been prescribed for them.
I was taking Pristiq for about 13 weeks when I developed nausea and severe sweats. I got off of the drug and the nausea went away but I am still having sweats and hot flashes. Now I dont know if the drug was the cause of the sweats or not. I am so miserable all day with the heat that my body feels like it is on fire. I get real sweaty and hot while I am sleeping also.
Now I read that Pristiq can help with hot flashes. I hae been feeling depressed and anxiety up and down since I have been on the Pristiq.
So now I dont know what is causing the heat and sweats ow. My family doctor says I am post menopausal which I already knew as I have not had periods for two years. this is like the chicken and the egg. I want to look into bioidentical hormones but Ilooked up the side effects of them and they are just as bad as the regular HRT.
joyce
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