Click here to listen to podcast interview.

Plaintiff attorneys and thousands of women have been maintaining, since the NIH’s pivotal findings in the Women’s Health Initiative in 1992, that hormonal compounds for menopausal symptoms have been aggressively and fraudulently marketed for long term use for many years despite the fact that these drugs are carcinogenic and were never studied (by the companies raking in millions in profits) for this potential health.

Click here to listen in, as Zoe Littlepage, one of the members of the trial team, and I discuss what this story is really about.

The study published in the April 4, 2007 edition of the Journal of the American Medical Association (JAMA) is actually a new analysis of findings initially reported in the Women’s Health Initiative which included over 27,000 women between the ages of 50 and 79. As it now turns out, women in their 50’s who take hormones for these quality of life concerns, are a bit “safer” then their older counterparts: they still run the risk of strokes and breast cancer– but at least not heart attacks.

Women are once again cautioned that they can not take these preparations with impunity and certainly only for the shortest period of time to ensure– or at least to provide– a modicum of safety. So what’s the big deal?

Since the findings were first reported in the Women’s Health Initiative– which was sponsored by our National Institutes of Health (and which was intended to prove that hormones actually provided coronary benefits to women taking these drugs for menopausal symptoms), we have learned that all women, regardless of their age, are at a higher risk of stroke and breast cancer. This has in turn spawned thousands of cases around the country on behalf of women who have indeed suffered otherwise preventable breast cancers as a result of taking hormones such as Prempro for long periods of time. Initially the medical community, encouraged by big pharma’s sales force tactics and through the industry’s aggressive advertising campaigns aimed at doctors and patients alike, keenly advocated long term hormone use under the mistaken impression that these drugs would provide cardio protective benefits and reduce the risk of heart disease, as well as delay or inhibit the onset of dementia, and thwart the development and progresssion of osteoporosis. In fact, only the latter (osteoporosis prevention) claim was accurate. In the meantime, many women suffering from menopausal symtoms, and many others who simply took the drug for these false benefits, suffered breast cancer, heart attacks and strokes as a result of hormone use.

Many women– in droves–abandoned their hormone drugs after learning of the risks. Some, quite reluctantly, due to the relief of menopausal syptmoms which the drugs provided. And since that time, the use of hormonal agents for the “treatment” of menopausal symptoms. has been a source of tremendous conflict within the scientific and medical communities.

This recent JAMA study is alarming– if only for the way in which its findings are being reported. NAMS (The North American Medical Society), put a diferent spin on the article concluding that “these findings should help reassure younger women who are considering use of Hormone Therapy for appropriate indications that such use does not include an increased risk of cornoary vascular disease”. But the risks of stroke and breast cancer remain– and the admonitions against long term use even for these women, is a given.

At the center of this is the drug Prempro- a synthetic combined hormonal prepartion , the estrogenic portion of which is generated through the processing of horse urine from impregnated mares, harvested in the most unconscionable and cruel manner imaginable.

The dangers of this particular agent which combined conjugated estrogen with synthetic progestin, underscore the unfortunate use of women as a marketable commodity. Consider that millions of women in this country alone are of menopausal age. Marketing menopause, then, as a “disease” to this huge population through direct-to-consumer advertising, and convincing the medical profession that these agents are actually beneficial to the health of women of a certain age, is a marketer’s dream come true.

This is not to say that certain women won’t benefit from hormones, but this is a quality of life decision, not a marketing game.

Central to the claims now being pursued around the country are the industry’s once aggressive and convincing but unproven and misleading claims that hormone replacement therapy was to be taken for years as a life prolonging and age retarding prepartion. Today of course in the wake of all that has happened as a result of and since the WH1 studies, the industry no longer promotes this view.

But in the end, it is still a choice for the woman and her physician– except now, the choice is made weighing the negatives: diminshed quality of life against enhanced risk of use. It sems to this observer, that perhaps it is time to find a proven safe method of releif rather than promoting ultimately hazardous agents for a shorter duration of use.

Historically, elderly claimants were not the most attractive legal clients. Apart from the obvious– many suffer from dementia and do not have the ability to assist in the development of their case–many well meaning attorneys have struggled with the potentially questionable value of a case brought on behalf of an 80 year old infirm victim of insurance abuse who may not survive the claim to its resolution. The insurance companies make good use of this- preying on the most vulnerable and insuring that payment delayed is care denied and insurance profits guaranteed.

Given that the fastest growing segment of our society is the aging population this is a massive business opportunity for carriers whose long term care policies cover costs for assisted living facilities, nursing homes and at-home care, among other necessaries. And those costs are staggering, as many people due to gokod health care, life beyond their (insurace actuarial) life expectancies.

The legal community, however, has recognized the substantial injustice visitied on this population and has taken aim on Big Insurance. If you or a family member have been denied payment under an exisitng long term health care policy of insurance, seek legal attention immediately. Restituion and affirmative action is available.

Thousand of claimants around the country—and many of their counsel—have anxiously awaited this New Jersey verdict (Humeston v Merck & CO., Inc. No ATL-L-2272-03 (N.J. Super4. Ct., Atlantic Cty.) with the expectancy that a second dazzling verdict would bring the manufacturing giant to its knees—or at least to its senses. Not so.

This was a fine result—but one that will most certainly be appealed both on the compensatory and punitive elements. But we must also remember that this is simply one verdict reached on the facts of an individual case. And Merck has long taken the view—one with which it has not deviated– that it will try each case individually.

Not a bad idea, given that the company maintains that many of the cases are specious, with proof of ingestion, oftentimes speculative, and underlying pre 0065isitng medial coronary risk factors the true culprit of the devastating injuries these Vioxx claimants sustained.

Accordingly, each case must still be litigated individually notwithstanding that there are thousands waiting for their day in court. And it would seem that it will take a lot more than one or two (what the company believes are aberrant) verdicts before the global dockets will be resolved.

In other words, it may still take years.

Interestingly- and consider the timing– just 10 days after the Humeston verdict was announced– the FDA implemented a ground breaking rule which limits the role of advisors to the agency. Expert advisors to the FDA—primarily physicians- who receive $50,000 or more from a company or a competitor whose product is being discussed will no longer be permitted to serve on the FDA committees or advisory boards within the FDA which are responsible for approval or removal of a drug form the marketplace. In the New York Times article which first published the FDA rules (by Gardiner Harris, March 22, 2007, pg 1) the newspaper cites to the most famous current example of the conundrum: Bextra, another dangerous Cox-2 drug which continued for a while to remain on the market as Vioxx was removed. This drug, some suggest, is even more dangerous than Vioxx was and is the subject of much litigation around the country. . There is no question that the legal evidence will ultimately bear out that Bextra was dangerous for many of its unsuspecting users, and that physicians knew little or nothing of these risks, but that these risks knowable and known to Pfizer and some of the advisors on the FDA. We now learn that ten of the 32 advisors, who voted in 2005 to allow Bextra to remain on the market, had taken money from Pfizer. The new rules would not have allowed their votes to be counted. To understand the significance of this, if the vote had been taken toady under the revised ruling the voted by the FDA would have been to immediately take the drug off the market. Rather than to permit it to remain. And while Bextra was ultimately discontinued, there were undoubtedly live of some users which were devastated in the interim.

Truth be known- a great deal of the choice should always be with the consumer. Pain is pain—and quality of life for some is worth the risk. But the problem has always been the risk-benefit analysis, and the public and their doctors should know the risks—and be able to weigh them when making an informed choice about treatment and quality of life. This the companies failed to do, seeking block buster status and reaping corporate profits without regard for public health and knowledge.

Many legal stalwarts have committed their energies to this endeavor—and will be on hand to offer their views on the site. Guest celebrities concerned about legal and political developments will also be chiming in about their views on the pivotal legal issues which dominate the headlines—all with the aim of producing a genuinely informative and entertaining information venue.

I am delighted you have joined the blogsite. Stay tuned!