S P E C I A L R E P O R T
Written and Researched by JANE ALLIN
Don’t be fooled by the pretty flower. This drug is produced using pregnant mare’s urine. They removed the “equine” from “conjugated estrogens” long ago. Not good for marketing. Image: PremarinVaginalCream.com
IT SEEMS lately that everywhere you look there are ads for Premarin, Premarin Cream and the new kid on the block Duavee*, also derived from Pregnant Mare’s Urine.
These sinister advertisements have been materializing repeatedly in numerous US magazines and more recently as a TV ad on iSpot.tv (http://www.ispot.tv/brands/onI/premarin).
Pfizer seems intent on peddling these ghastly drugs and are busy infiltrating various media sources in an attempt to retain and grow a solid market share for these HRT therapies regardless of the inherent and proven risks they pose to menopausal women. This is by no means a mystery or surprise.
To start, Pfizer had a lackluster first quarter this fiscal year – a trend of enduring profit decline together with a dearth of blockbuster drugs emerging on the pharmaceutical front in the near and distance future. The primary causative element in this fiasco for Pfizer, and other leading pharmaceutical companies, is the loss of patent exclusivity of drugs in the forefront of patient care in the wake of chronically over-diagnosed diseases.
“Beginning in 2010, the pharmaceutical industry faced one of the biggest waves of drug patent expirations in history, a phenomenon referred to as the “patent cliff.” A significant number of top-selling drugs in the history of the pharmaceutical industry will experience patent expirations over the next 5 years, paving the way for lower-priced generics.” 
Once drugs lose patent protection, lower-priced generics have the capacity to capture 90% of their sales. This translates to billions of dollars loss in profits over the near term. Brand name drug companies such as Pfizer have been actively seeking ways to mitigate these enormous losses in revenue that have been or soon will be lost.
Some of these measures have included increased drug prices starting as far back as 2002 in anticipation of patent losses, contractual deals with generic drug makers for “authorized generics” that guarantee a portion of the sales, reductions in research budgets, staffing levels and partnering with other drug companies to share development costs. 
Just like Wyeth’s/Pfizer’s strategy and the relocation of the North American PMU industry, many are shifting more of their manufacturing and patient testing to low-cost countries such as China and India. Moreover sales tactics are now geared to infiltrate the untapped markets in these emerging counties to stabilize sales and offset the losses that will be incurred in North America and elsewhere.
And of course there are the ever-present advertising and marketing ploys. In 2012 alone, the $300 billion a year US pharmaceutical industry spent $3.1 billion on advertising prescription drugs directly to consumers. 
In a gullible nation that has been brainwashed by Big Pharma, and their physicians who receive 95% of their information from this very source, there is little difficulty persuading the masses that drugs are the answer to any “condition” regardless of the fact that many of these so-called illnesses are treatable by lifestyle changes or, in effect, are not diseases at all.
In practice many of these “conditions” have been created by poor lifestyle choices at the outset. But for many it’s simply easier to take drugs to combat the problem – America, the pill popping nation. In fact prescription drugs are the fastest growing sector of US healthcare costs. 
But rather than resort to developing new therapies that will potentially unleash breakthrough remedies to the insidious diseases that presumably haunt the prospect of life itself, they choose to rely on cloned drugs that are for the most apart novel because they have manipulated patent laws based on old research and old technology – a mere codicil to an existing patent.
Duavee is a prime example; the combination of two questionable drugs with risky side effects – Premarin + the SERM (Selective Estrogen-Receptor Modulator) bazedoxifene (currently not FDA approved) – an accident waiting to happen.
In fact, pharmaceutical companies spend proportionally more money are marketing than on R&D. And market them they do – at the expense of innovation and patient safety.
"Pharmaceutical companies have developed a business model that emphasizes new variations on existing drugs, rather than groundbreaking medical advances, a report in the medical journal BMJ states.
"Prescription drug companies aren’t putting a lot of resources toward new, groundbreaking medication, according to a recent report in BMJ, a medical journal based in London. Instead, it’s more profitable for them to simply to create a bunch of products that are only slightly different from drugs already on the market, the report’s authors said.
"[P]harmaceutical research and development turns out mostly minor variations on existing drugs,” the authors write. “Sales from these drugs generate steady profits throughout the ups and downs of blockbusters coming off patents".
The authors go on to say that for every dollar pharmaceutical companies spend on “basic research,” $19 goes toward promotion and marketing. And apparently it’s been working.
Drug company revenues climbed more than $200 billion in the years between 1995 and 2010, according to the website MinnPost. Meanwhile, in recent years, more than one in five Americans age 50 and up have had to cut down on their dosages or switch to cheaper generic drugs because the cost of medication is so high. 
Drug safety is no longer first and foremost in the quest to market pharmaceuticals. Reports of established and emerging drug therapies continue to raise disturbing questions in regard to their safety.
Ultimately the troublesome question remains as to the efficacy of the research provided to access the long-term risks associated with these drugs. Is the current system (i.e. FDA, Big Pharma, Physicians) equipped, or more aptly put, is it providing the necessary precautions and due diligence to ensure that the risks of any marketable drug are minimized?
Sadly, the answer is no.
Money and profit rule at the expense of ethics and moral conduct. The flaws outweigh perception and truth. And this kind of blasé attitude is applicable not only to new renditions of old drugs (e.g. Duavee) but rather to old drugs – such as Premarin and the like – because the primary engine that drives this industry is money. It is no secret that the pharmaceutical industry is without shame in promoting unsafe drugs at the expense of the consumer – you and me.
Even today, long past the damning WHI study, reports are still emerging that link the conjugated equine estrogens (CEEs) found in the Premarin family of drugs to increased risks of cardiac failure, strokes, cancers, pulmonary embolisms and dementia among other life-threatening diseases. This raises serious and disturbing questions regarding the current state of medication safety overall, not just for these HRT drugs.
Uncertainty arises as to the efficacy of the research conducted, how long it should take to assess long-term safety in addition to the accountability of the FDA, pharmaceutical companies and physicians and whether they are doing enough to minimize long-term risks. Yet, at the same time are still sanctioned by the FDA and marketed as “safe” albeit with some conditions that are intended to ease the minds of those who choose to take them and effectively erase all the bad from the past.
Such is the case for the ever-present Premarin and the newly concocted sister drug Duavee.
As far back as the 1970’s there was damaging evidence about the risk of cancers and cardio vascular disorders using CEEs (conjugated equine estrogens), long before the arrival of Prempro® in 1995 and finally the WHI which undisputedly linked HRT with increased cancer and cardio risks among others.
These CEE-derived therapies are identical to the drugs on the market today – they haven’t been modified to make them any safer, nor have they any true generics to compete against them.(see https://tuesdayshorse.wordpress.com/2014/03/27/daughters-of-premarin-the-generics).
No, Pfizer has the market cornered when it comes to horse pee and has worked determinedly (as did Wyeth prior to the takeover) to convince the public that Premarin is considered the “gold standard” for treating menopausal symptoms. A hangover from the old days despite the long ugly history for these drugs – adulterated with deception, conspiratorial marketing campaigns, fraud and most importantly death.
Pfizer simply continues by sponsoring studies of its own drugs to support more favorable outcomes for their carcinogenic potions.
“It’s clear from the start that there is a deep conflict of interest in pharmaceutical companies sponsoring trials on their own drugs. Industry sponsors 90% of published clinical trials. A worrying statistic given that, as Goldacre shows, industry-sponsored trials are four times as likely to produce positive results than independently run experiments. . . . About 85% of clinical trials are now funded by the drug industry. They own that data. The docs don’t understand that they are getting a selected, filtered version of what the information is.” 
Apparently this is the reason that Premarin and its daughter products are considered safe despite the fact they are known carcinogens – an abysmal conflict of interest.
How comforting. And it is no different with the controversial drug Duavee.
To begin, the quest to gain approval for Duavee from the FDA started long ago when Wyeth Women’s Health talked about this drug coming to market by 2005.
Repeatedly Wyeth and then Pfizer faced innumerable obstacles due to the inherent risks of two very contentious drugs – Premarin an established carcinogen and bazedoxifene implicated in the onset of strokes for example.
While studies have confirmed that Duavee is effective in relieving moderate to severe vasomotor symptoms (VMS), vulvar and vaginal atrophy (VVA) associated with menopause as well as the prevention of postmenopausal osteoporosis, the jury is still out on the safety aspect.
Most disturbing is the fact that bazedoxifene has failed to receive approval from the FDA and is itself not without issues.
Clinical trials have indicated an increased risk of stroke in addition to higher incidences of deep vein thrombosis, retinal thrombosis, hot flushes and leg cramps compared to placebo-treated subjects. These are well-known side effects of SERMs which are also known to increase the risk of endometrial cancer.
This together with limited safety data on Duavee does not bode well — cancer is an insidious disease and can take years to develop. This is exactly what happened with the Premarin® family of drugs — not just the combination Prempro® therapy. Yet word has it that this drug will soon be approved in the EU as well.
It comes as no surprise however that Pfizer has a proven track record of promoting drugs in ways not necessarily backed up by medical science.
The usual tactic employed is one in which insufficient details of clinical trials are published, frequently authored by individuals who will benefit financially from the companies whose drugs they are writing about – often these articles are deficient to the point of being misleading.
Case in point, in 2009, Pfizer was endemic to the largest health care fraud settlement ($23 billion) and criminal fine of any kind ever over its painkiller Bextra – since withdrawn.
“Besides heart attacks and other dangerous side-effects, Bextra had even been known to cause Stevens-Johnson syndrome, which begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters, eventually causing the top layer of your skin to die and shed…
“…and Pfizer’s CEO and board of directors knew this, but had their salespeople push it for profits anyway. The fine was paid with a single wire transfer (easy money!)
“And no one went to prison….just like with the bankers.
“Pfizer, as the corporation that manufacturers, markets, and distributes these miracles of modern medicine, takes on a more macabre quality. This is what happens when a company gets ‘too big to fail’. They stop thinking of their customers as real ‘people’, and they start becoming just ‘revenue streams’.” 
Is the marketing strategy of the Premarin family of drugs any different? I don’t think so.
Given the callousness and lack of accountability this incident and others like it demonstrate, how can any physician be lulled into a sense of assurance that these HRT regimens are safe and be comfortable in prescribing these to their trusting patients?
The answer is simple – the power of persuasion, manipulative marketing practices and often kickbacks for promoting medications that will return tidy profits.
“The free samples are for doctors to give their patients in the hopes that their next dose will come from a paid prescription, written by your friendly physician who, somehow or other, found the time to meet with the rep, while you continued to cool your heels in the waiting room.
“First, drug companies would not be so generous if their investments in giveaways did not net enormous returns. Pharmaceutical companies spend an estimated $20 billion a year on marketing to physicians, while prescription drug sales top $300 billion.
“And second, several studies determined that doctors, like all human beings, are subject to the natural tendency to want to give something back to a gift-giver, in a dynamic psychologists call reciprocity.
“In a 2000 article in the Journal of the American Medical Association, Dr. Ashley Wazana of McGill University in Montreal analyzed 29 studies on doctors’ prescribing behavior in Canada, Australia, New Zealand, Holland and the United States. Wazana noted, among other things, that:
• Free samples made doctors “significantly” more likely to prescribe a specific drug
• Freebies led doctors to ask the drug be placed on formularies† (hospitals’ official lists of drugs that can be prescribed)
• Accepting a free trip to a drug-company-sponsored conference guided doctors to write more prescriptions of the company’s drugs, a spike of 80 to 190 percent
• Doctors who ate pharma-sponsored meals “occasionally” were two to three times more likely to ask that the sponsor’s drug be placed on a hospital formulary.
“While the traditional practices of trying to influence doctors with free samples, assorted freebies and exotic vacations to have them prescribe more of their drugs have diminished in scope, Big Pharma’s inducements didn’t disappear. They merely shifted.” 
* Duavee was originally submitted for FDA approval under the name Aprela. The name was changed in the “final hours” of the application process.
† Formulary (meaning): An official list giving details of medicines that may be prescribed.
Part 1. Introduction | Part 2. Safety: Big Pharma, Bad Medicine | Part 3. Advertising: Exploiting the Public for Power and Profit