FDA rejects possible Premarin replacement drugs

The underlying question begs whether these drugs are truly ineffective or whether there is an ulterior motive to the FDA committee’s decision

This applies from all perspectives. It really doesn’t matter whether something is a viable product or not, it is all a game of power – in this case, as with the rest of everything today, paralleling the size of a portfolio, the almighty dollar and the irreparable demise of democracy.

That said, the underlying question begs whether these drugs are truly ineffective or whether there is an ulterior motive to the FDA committee’s decision. Ostensibly these drugs would penetrate the Premarin® market. Moreover from a historical perspective it is well recognized that big pharmaceutical companies such as Pfizer – the world’s largest – are in bed with the FDA and the drug approval game is yet another version of the Insider controlled monopoly play.

After all neither Depomed nor Noven make the top 100 pharmaceutical companies list and money talks. A most insightful article entitled “FDA’s Own Scientists Describe Intimidation of Big Pharma” authored by Dr. Betty Martini and D. Hum paints an ugly picture of the truth behind the façade.

“The drug industry today is a massive criminal enterprise operating in broad daylight, and the FDA is its chief enforcer. It has nothing to do with honesty, integrity or even health, but everything to do with generating obscene profits, exploiting patients and controlling information through intimidation.”

[16]

Expendable to Pfizer - No Premarin
Artwork by Vivian.

Given the position Pfizer is in with respect to the HRT market and its pending NDA approval for the controversial combined menopausal-osteoporosis drug Aprela® it would come as no surprise if some clandestine negotiations transpired – so typical of the lawlessness of the FDA and Big Pharma immunity.

Overall a sad outcome for some potentially promising drugs – drugs that would spare the suffering of the PMU mares and their foals.

Fortunately not all the news is bad news.

APRELA

A recent Global Data expert insight article – “Pfizer’s Aprela Could Struggle to Surmount Approval and Reimbursement Hurdles” – authored by Michael Leibfried, Senior Healthcare Analyst for Cardiovascular and Metabolic Disorders predicts that Pfizer’s anticipated long-awaited approval of its combination menopausal-osteoporosis drug Aprela® may falter at the gate.

“Pfizer, one of the world’s largest pharmaceutical companies, is looking to make its last stand in the osteoporosis space in 2013. The company, which has seen divestitures and patent expiries ravage its osteoporosis portfolio, is putting its hope in mid- and late-year approvals of a combination product, Aprela (bazedoxifene and conjugated estrogens), in Europe and the US, respectively. However, this do-or-die year for Pfizer’s osteoporosis portfolio could spell more disappointment than success”[17]

With Aprela Pfizer has essentially taken two drugs with significant safety concerns and packaged them together

Aprela® is a combination of Premarin®, which lost patent protection in February 2012, and bazedoxifene, a selective estrogen receptor modulator or SERM also known as Viviant® specifically developed to help prevent postmenopausal osteoporosis. Of particular note is that Viviant® has failed to receive approval from the FDA as a result of increased risks of stroke and thromboembolic events although it has been approved for use in other countries {i.e. Italy and Spain (Conbriza) and Japan (Viviant)} under different trade names.

Last July Pfizer submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) and shortly thereafter a New Drug Application (NDA) to the FDA in December 2012 for the treatment of the symptoms of menopause and prevention of postmenopausal osteoporosis.

It comes as no surprise as to why there would be impediments to the approval – at least from an ethical perspective if nothing else.

“Pfizer has essentially taken two drugs with significant safety concerns and packaged them together. As stated above, the FDA recommends that conjugated estrogens not be used solely for the prevention of osteoporosis, except in women at high risk. Add to the mix that bazedoxifene could increase the risk of thrombotic events, and this becomes a perfect scenario for an FDA denial. GlobalData believes that the FDA could consider approving Aprela for the treatment of the symptoms of menopause; however, we believe that approval for the treatment of osteoporosis could be far-fetched.”[18]

The article goes on to suggest that approval is more likely to advance in Europe given the agency’s history regarding new drug regulations which are somewhat more lenient than those in the US.

However, for Pfizer, the caveat is the availability in Europe of generic raloxifene (marketed as Evista by Eli Lily), another SERM that has estrogenic actions on bone and anti-estrogenic actions on the uterus and breast currently used for the prevention of osteoporosis in postmenopausal women – a cheaper and potentially safer alternative without any hormonal components derived from pregnant mare’s urine.

Let’s hope that GlobalData’s closing remarks are a reflection of the prospects for Aprela®’s impact on the postmenopausal drug market for both osteoporosis and relief of menopausal symptoms.

“As a result of all of these factors, GlobalData believes that should Aprela gain marketing approval in the US and EU later this year, the drug is more likely than not to have a minimal impact on the osteoporosis market. We believe that even with Pfizer’s marketing expertise, Aprela will not be able to surpass the mounting wave of mediocre efficacy data, a suspect safety profile, reimbursement and regulatory bias, and the perception that the company seems to have waning interest in its osteoporosis portfolio. Thus, Aprela could get lost in a sea of inexpensive generics and novel and more efficacious drugs that will reach the market over the next few years.”[19]

© Int’l Fund for Horses

ENDNOTES
[1] http://www.empr.com/nda-submitted-for-low-dose-paroxetine-mesylate-for-menopausal-vasomotor-symptoms/article/256576/#
[2] http://seekingalpha.com/article/1143091-serada-approval-presents-big-upside-to-depomed?source=google_news
[3] http://www.noven.com/PR111212.htm
[4] http://www.depomedinc.com/view.cfm/1337/Seradatrade-Gabapentin-GR—Hot-Flashes
[5] Ibid.
[6] http://graphics8.nytimes.com/packages/images/nytint/docs/design-write-medical-writing/original.pdf
[7] See Endnote 2.
[8] http://www.drugs.com/monograph/gabapentin.html
[9] See Endnote 4.
[10] http://www.healio.com/endocrinology/reproduction-androgen-disorders/news/print/endocrine-today/%7Bac759ad0-eb54-4e98-b2e9-454347f7e0f0%7D/low-dose-mesylate-salt-of-paroxetine-effective-in-treating-vasomotor-symptoms-
[11] http://latestrxsys.blogspot.com/2012/10/menopausal-hot-flashes-relieved-by-low.html
[12] http://www.noven.com/PR030413.htm
[13] http://seekingalpha.com/currents/post/865161
[14] See Endnote 12.
[15] http://www.whale.to/v/quotes2.html
[16] http://rense.com/general72/fdasown.htm
[17] http://www.globaldata.com/ExpertsInsightDetails.aspx?PRID=592&Type=Industry&Title=Pharmaceuticals+and+Healthcare
[18] Ibid.
[19] Ibid.

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15 thoughts on “FDA rejects possible Premarin replacement drugs”

  1. Apparently I’m one of the very lucky ones…I actually had to be convinced by my doctor that I had in fact proceeded through the entire menopause syndrome – without knowing it! :)

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  2. Years ago my dr at the time prescribed Premarin. Took it for several months before I found out where it comes from! That was the end of that.

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  3. None of us will ever know how much money Pfizer has shelled out to the FDA over the years. I never took any of the drugs my doctor tried to push on me for hot flashes. I lived in AZ so you really couldn’t tell a hot flash from the 110 degree weather. I never had any problem with it. Not taking any of the drugs probably saved my life.

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  4. Vivian – I love it when you and Jane Allin get your research on; it’s SO important that women understand menopause isn’t a disease nor is it terminal and there are so many alternatives to (you should pardon the crudity) mare piss and slaughtered foals.
    I have to wonder about the hue and cry up from the male population if it were known that Viagra was derived from conjugated bull sperm…(it isn’t, but it amuses me to ponder it so.)
    Is it wicked of me that I actively pursue those vitamin and mineral supplements or herbal remedies that specifically state “This (product) has not been evaluated by the Food and Drug Administration”? It astonishes me this agency is still in business, that it’s recommendation are still held sacred and that it’s opinions carry global weight.
    That’s why these articles are so important, even outside the horse community. Women need to know our health is not now, nor has it ever been, the top priority – our money is.

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    1. Thank you Lisa. Jane has done a stellar job once again. The horses are blessed to have skills working in their defense. Insofar as any of those government alphabets, I feel the same way when I see the USDA sticker on food.

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  5. Many women who have to go on to hormones during menopause, are now using bio-identical hormones which are derived from plants and have less risk.

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  6. Premarin killed my mother,she died 4 years ago from breast cancer. There are safer options out there,I took Prozac for hot flashes and it was like a miracle drug. Went from one hot flash right after another all day every day ….then none at all when I took the Prozac. I took it for 4 years and quit,now I might have one hot flash per day. It works ladies!!

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    1. I used Estradiol as well and it was great! I told my doctor I refuse to take Premarin and she said Estradiol is just as effective. However, she did take me off it after a year and a half (the recommended length of time before risk of breast cancer). She takes her patients off ALL HRT’s after a year and a half, including Premarin due to the same risks. She suggest supplements to replace HRT’s.

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  7. Women like Premarin also because their wrinkles are not as noticeable. But taking the drug can lead to cancer and doctors have taken their patients off of it. Breast cancer is nothing to disregard, while this is criminal for our mares and their foals.

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  8. God forbid that we should stop the suffering of the mares and use something that would not cause harm. There are herbal alternatives out there that work just as good. This is all about the drug companies wanted a hold on your money.

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