Women's Issues


Study Finds that Women’s Awareness of Hormone Therapy Risks is Limited

A new study just published in Menopause: in the Journal of the North American Menopause Society (Women’s Awareness and Knowledge of Hormone Therapy pos- Women’s Health Initiative, Rigby et al., (Vol. 14, No.5, pp. 853-858) suggests that most women considering hormone replacement therapy for their menopausal symptoms still remain perplexed or unknowledgeable about whether the risks of the drugs outweigh the benefits, with an alarming 63 percent of those surveyed revealing that they were unaware of the pivotal findings announced in the National Institute of Health’s Women’s Health Initiative in July 2002. It should be recalled that that federally funded sturdy revealed health risks for women on an estrogen plus progestin regimen, and new guidelines were accordingly issued for women to avoid these drugs for disease prevention, and to limit the use and ingestion for menopausal symptom relief to shortest necessary time frame. The study revealed that even among those women who professed some knowledge about the study, the majority underappreciated its findings and held certain misconceptions about the impact of these drugs for colorectal cancer, memory loss, blood clots and stroke. Although knowledge was greatest for breast cancer risk, many women- most notably in the black communities or among less educated populations, demonstrated what the study concludes is a “wide gap inpatient awareness and knowledge of the potential risks of HT despite wide spread media coverage of the evidence of harm form the WHI trials and a national decrease in HT prescribing.”

The Debate Over Gardacil Continues

The very heated debate over the efficacy and safety of the voluntary (and in some states legally mandated) use of Gardasil in the pre- teen and adolescent populations here and across the globe continues with no apparent resolution in site. Gardasil , one of Merck pharmaceutical’s newest potential blockbuster drugs, is a vaccine that targets the virus responsible for cervical cancers and genital warts. The argument goes that mandating vaccinations for young girls entering puberty will protect them from developing cervical cancer—and save lives. Trouble is, vaccinating girls as young as nine and into their late twenties for a virus that may produce cancer thirty years later is a numbers game about which no one—not even the manufacturer- can confidently predict success or safety.

Here is what we do know: the human papillomavirus or HPV is the most common sexually transmitted infection in the United States, and is associated with the development of cervical cancer. Although there are close to 100 HPV types ( 30 to 40 of which can be sexually transmitted) and 15 types associated with cervical cancer, Gardasil targets only four: HPV-6, HPV 11, HPV -16 and HPV-18. Currently HPV-16 and 18 account for nearly 70 per cent of all cervical cancers, and HPV-6 and 11, for about 90 per cent of all genital warts. In the US alone it is estimated that 20 million people are infected with this potentially deadly virus. According to the Centers for Disease Control, by age 50 nearly 80 per cent of all women will have been infected with and HPV through sexual contact.

We also know that there are nearly 10,000 new cases of cervical cancer diagnosed annually in our country alone. According to the American Cancer Society, roughly one third will die from the cancer. Worldwide cervical cancer is the leading cause of cancer death in women, with 470,000 new cases and 233,000 resultant deaths each year, according to the FDA.

Disturbing as it may be, puberty and sexual promiscuity these days seem to start at around age nine- just when many young pre- pubescent girls are entering the 5th or 6h grades. If then, Merck is right, that we can address and conquer nearly 70 per cent of all causes of cervical cancer with a simple vaccine, in order to insure maximum effect the recipient must be vaccinated before sexual contact and infection or before sexual contact starts, because the drug is not affective in those already exposed to HPV..

Trouble is, the manufacturer can’t answer the most elementary question: first and foremost, what are the long term effects on vaccinating these young girls.? Currently there is a substantial lack of any long term safety data. More disturbing, the only clinical trials demonstrating safety were conducted by the manufacturer itself, and the studies were outsourced to a for-profit consulting company whose income and profits were based on the success of getting the Gardasil drug to market.

These days we all know that the FDA is under- funded , under -staffed and overworked. The agency relies on the company’s data, and often the data is flawed, leading to subsequent usage and dosing warnings, and even product withdrawal from the market after many patients have been harmed or placed at physical risk. Worse still, many of the FDA ‘s Advisory Committee members historically have had conflicts of interest with nearly 30 per cent having had at least one such conflict . We are talking here about conflicts in which the Advisory Committee members have received a per centage of income on projects in which they have been hired by or consulted with the very pharmaceutical companies whose drugs they are evaluating. Another problem is that the very company promoting the drug is often responsible for carrying out and reporting the findings of its post marketing surveillance studies to the FDA. This in turn has lead to under reporting of adverse events, or dismissive explanations the physicians, patients and the FDA.. Recent headlines support these critical flaws in the current marketing ad post surveillance procedures currently in place—just look at he Vioxx debacle , just one in a long list of overzealously marketed drugs which failed to deliver.

While no one would argue that the elimination of a deadly cancer is a worthwhile aim, let’s look at the cost /benefit of riding this wave. Cervical cancer in this country, has been on the steady decline since 1975. This is due in large part to the advent of routine annual pap smears, which provide early diagnosis and treatment intervention of cervical cancer. The greatest numbers of undiagnosed and untreated cervical cancers in this country and world wide, affect people of color or poor women who do not have regular access to gynecological health care. Accordingly the largest benefit, and the greatest risks, fall upon this population segment.

We have no guarantee how long the vaccines will last—the best guess is about 4 years. So efficacy requires a lifetime commitment to vaccination. That's good news for Merck, which right now is the sole manufacturer of any gynecological cancer vaccine and could expect billions in profits if wholesale vaccination of the pre -teen and adolescent public is endorsed.

Still unknown is whether the 13 other high risk HPV types could replace the two targeted by Gardasil, thereby eliminating any benefit with widespread Gardasil vaccination, making the whole affair a grand misadventure for the public, and a financial boom for the manufacturer.

Finally and most alarming are the adverse reactions which have been reported, and not just a few. So far over 600 events from seizures, to numbing of the extremities, vision and speech problems, Guillien Barre syndrome and other neurological symptoms have been reported and associated with Gardasil vaccinations.

In the end, we need to ask these important questions: if cervical cancer is rare and on the decline, if pap smears prevent cervical cancer or insure early detection and treatment and if the long term health consequences of the vaccine are unknown, is it entirely wise to subject the entire population of our female children to this treatment?

Sexual Harassment and Teens in the Workplace

The Untied States Equal Employment Opportunity Commission (EEOC) reports that between 2001 and 2005 an increased number of lawsuits were filed on behalf of teenage employees who had been sexually harassed at the workplace. Sexual harassment to this particularly vulnerable segment of the workplace population seems to be on the rise. A survey by the American Association of University Women reported in 2001 that 83 per cent of teen aged girls and 79 per sent of boys responding to their survey had reported sexual harassment. A 2002 study of more than 300 high school student surveyed in the a study by the University of Southern Maine reported that 25 per cent of students surveyed had experienced sexual harassment- and a staggering 63 per cent were girls. In a subsequent study in 2005 the same researchers fond that 47 per cent of girls surveyed reported sexual harassment on the job. This included assault, stalking and attempted rape. While in the past, young teens and their parents were more likely to avoid confrontation which might encourage social ridicule and embarrassment, a more savvy teen aged and parental population now recognize the substantial emotional and financial harm which these situations create, and that seeking legal redress is an important key to ensuring workplace safety and promoting an harassment-free environment

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Ovarian Cancer- a Diagnositic and Prognostic Nightmare

If ever there was singularly one cancer, which requires aggressive diagnostic investigation, it is Ovarian cancer. Left untreated and undetected the cancer may grow rapidly beyond the ovary, with very little chance of cure once the cancer has progressed beyond the early stages. Once spread to distant site, the disease carries a five-year survival rate of only 30 per cent. Although there is no gold standard diagnostic screening tool such as mammograms for breast cancer, the best treatment is still early diagnosis, and recognizing the early symptoms is essential. Women cannot rely on routine pap or gynecological exams, since these oftentimes do not result in diagnosis. And many physicians are often remiss in recognizing the early signs ok the disease resulting in further delays in diagnostic work-up and treatment. But the early identification of specific relatable symptoms may prove the best tool now for women and their physicians. Ovarian cancers once called the “silent killer” due to the absence of widely accepted and recognized symptoms, wreak havoc on women and their families. The American Cancer Society estimates there will be 22,430 new cases of ovarian cancer in 2007 in the United States alone. The cost to families, and the economy, is overwhelming. Missed diagnosis remains a critical problem often the subject of malpractice claims—but without hope of cure.

In June 2007 The American Cancer Society along with the Gynecologic Cancer Foundation and the Society of Gynecologic Oncologists relying on recent medical studies opined that identifiable symptoms often do exist for ovarian cancer, even in the early stages. The most common of these are:

» Bloating
» Pelvic or abdominal pain
» Trouble eating or feeling full quickly
» Urinary symptoms, such as urinary urgency

Still other groups are pressing for the general use of transvaginal sonograms, such as my friend and colleague actress Fran Drescher in her newly formed not for profit organization: Cancer Schmancer.

For more information on this technique and the recommendations of the ACS please visit www.cancerschmancer.org and www.cancer.org

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Are New Breast Cancer Screening Methods Worth the Cost?

More confusing mammogram news—recent statistics show that regular mammograms for women in their 40’s can reduce the risk of breast cancer related death, but “only” by a modest amount: for every 10,000 women screened six breast cancer deaths may be averted. And many more women may find that they have received a false positive result, causing them to undergo further testing including biopsies for lesions which may have been falsely identified. We are also told that women are being exposed to risks of radiation from the mammogram screenings-although the amount of rads are quite minimal these days with modern screening machines.

In a recent guideline issued by the American Cancer Society Magnetic Resonance Imaging studies (MRI’s) are now being recommended along with mammograms for all women, and importantly those at higher risk for breast cancer. But now we learn that even the MRI scans are getting mixed reviews with the New York Times reporting in its editorial of April 7, 2007 that while the MRI can may pick up tumors that mammograms missed, they also find harmless or benign but potentially suspicious growths which require further diagnostic work up and perhaps biopsies which would have otherwise be unnecessary.

The Times concludes that the government and private insurance companies ought to “reconsider whether the systems are worth covering” because they “drive up costs for no clear medical benefit”. That’s some faulty and dangerous thinking and can lead to even more dangerous action on the part of the private heath care insurance industry already heavily criticized for its archaic and inhumane methodologies. Ask the women whose lives we saved whether these tests are worth the cost.

Let’s not forget that breast cancer, along with heart disease, are the two leading causes of death among the female population. If the argument at hand is whether sparing cost overrides saving lives would anyone truly argue in favor of the former?


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Misdiagnosis of Coronary Disease

Heart disease is the leading cause of death among American women; and yet according to the American Heart Association a surprising number of physicians, in fact an “overwhelming number" of physicians, are apparently ignorant about the basic, important facts of women and heart disease. Studies show that the public and the medical community mistakenly believe that coronary disease is a “man’s disease”. And while public awareness of coronary risk factors in women seems to be growing, physicians have failed to address this serious public health issue with their patients. Critically, many early warning signs of cardiac disease are commonly ignored by female patients and their physicians alike. This leads to misdiagnosis, under treatment, and life threatening consequences. It is generally believed that symptoms of heart disease and impending heart attacks are similarly manifested in both men and women; however, the telling sings of cardiac disease and heart attacks in women are expressed differently, and oftentimes ignored. Significant signs and symptoms in women include jaw pain or ache; fatigue or shortness of breath. In many cases, there are no warning or prodromal signs at all. In a 2003 article appearing in the journal “Circulation” the authors alarmingly reported: “Little is known about early warning or prodromal CHD symptoms in women. In our earlier work, 85% to 90% of women identified an array of prodromal symptoms to their AMI. Some reported ignoring these symptoms, whereas others repeatedly sought medical assistance only to have clinicians minimize, misdiagnose, or ignore their symptoms.

Women associated these symptoms with CHD because they either appeared or changed in intensity or frequency before their AMI and disappeared or returned to previous levels of intensity or frequency afterward.13 Women indicated that they needed reflection time after the AMI to accurately identify prodromal symptoms. Because previous studies usually queried women within a week after AMI,15,16 they most likely missed important prodromal symptoms. Accurately describing women’s prodromal and acute symptoms of CHD is a vital step in providing a complete picture of women’s typical presentation. The current description of “typical” cardiac symptoms is based primarily on the experience of white, middle-aged men, with deviations called “atypical.” Researchers have speculated that this label contributes to misunderstandings in clinicians and lay individuals, leads to inaccurate diagnosis, and causes women to delay seeking treatment.”

In the four years since the article first appeared, coronary related deaths have continued to rise in the female population. The American Heart Association recently posted health tips for women, to reduce their cardiac risks, and to increase their awareness’ about the signs and symptoms of cardiac disease.

Of course, if you or a loved one has suffered from coronary disease which has been improperly treated or diagnosed, you may have a legal claim and should seek immediate legal advise to insure that your legal rights are fully protected.

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Failures of Mammogram Reports to Minority Women

In a recent study reported in the American Journal of Public Health ( March 2007, Adequacy of Communicating Results From Screening Mammograms to African American and White Women, Jones et al) ) we have learned that African American women were significantly more likely to received inadequate communications following their screening mammograms. The consequences of this communication failure are obvious: with delayed diagnosis, or perhaps no diagnosis, treatment is delayed or perhaps not given at all. The results, unfortunately, of this scenario, are tragic.

While communication failure of mammography screening results has been a considerable problem in the past, leading to progression of disease and exhaustive medical malpractice claims, there has been a push in the medical community to insure that women are provided with adequate information as soon as possible. But the failures which continue in the African American communities,-- particularly where abnormal mammography findings have been identified—is inexcusable and a tragic public health debacle.

While affected women and their families may ultimately seek legal redress for these failures, the answer does not lie in the legal community. After all, we are called in after the fact- to insure that the injured claimant receives just compensation for injuries visited upon her from a failed medical system. The answer lies in developing more effective communication networks. Women who have undergone screenings must be fully instructed on the importance of following up on the results—making the women and the screeners partners in an important medical process.

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Big Pharma Wants You

Recognizing that more than 80 per cent of all healthcare purchasing decisions are made by women, it should come as no surprise that the pharmaceutical companies are now focusing on the powerful women’s consumer population in the industry’s direct to consumer (D-T-C) advertising campaigns.

It is estimated that nearly 2 billion dollars was spent in television commercials alone in 2005- 2006, as the industry continues to promote the benefits of a myriad of prescription and over the counter drugs to the public in the hopes that the consumer will march to the local drug store, or internist, with requests for the newest pharmaceutical answer to sleeplessness,, anxiety, arthritis, attention deficit, menstruation and menopause, to name just a few.

In the recent editorial by Kessler and Levy in the January 2007 issue of the Annals of Family Medicine the authors find the pharma marketing push” disturbing” and question whether the industry is “truly acting for the public benefit”.

As a lawyer practicing in this ever divergent field of pharmaceutical negligence, I have seen a manufacturers rush to market the next “block buster” drug as the drug visits horrific damages on the unsuspecting public with adverse side effects and otherwise avoidable injury and death . The legal consequences for failing to adequately test or warn are significant, with companies oftentimes forced to alter their warnings or even remove a drug form the marketplace, as in the case of Vioxx. But all too often, this is too late for the unsuspecting consumer, who, believing perhaps all too innocently that if its advertised it must be good, is seriously and permanently injured from use of a drug, the risks of which far outweighed the benefits to that individual.

As Kessler and Levy astutely point out, direct to consumer advertising has brought to light some serious ethical issues as Madison Avenue seems to have replaced the doctor in her role as the as the ultimate communicator of health information to an unsuspecting public looking for a “simple answer to a complex question.”. Serious concerns about risks, medial history and lifestyle issues are not easily addressed in a 30 second commercial spot, and in some cases vital medical information is glossed over or omitted leaving the consumer with a dangerously simplistic view of the drugs’ benefits and risks. Most alarmingly, the authors refer to an FDA survey which showed that nearly 41 per cent of physician questioned, reported that the patients were confused about drug efficacy because of television commercial. A significant percentage of doctors also reported that the felt “pressured to prescribe a drug” which the patient had requested.

The female consumer remains at the center of this debacle for it is surely she who comprises that very population barraged with nearly 16 hours of drug ads annually. That’s a number which far exceeds that annual number of hours most of us ever go to, or speak with, a physician!

These ads, it is feared, focus less on public education, and more on emotional appeal and consequently both personal medical, and family health care decisions are fostered from manipulative advertising, Women and children in the long run, pay the price.

So as revenues increase from the sales of osteoporosis drugs like Fosomax, menopausal drugs like hormone replacement therapy Prempro), birth control drugs (the Ortho Patch) and other oral contraceptives,-- all strongly and aggressively marketed to women in print and in television, and as law suits follow from the injuries and adverse effects stemming from the use of these drugs, it gives one pause.—to consider the old adage-: profits over people.

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Hormone Use and Breast Cancer Link Reaffirmed

Another drop in annual breast cancer rates between 2003 and 2004 has led leading health care researchers to conclude that discontinuing the use of hormone replacement therapy is responsible for the declining rates.

Reporting in the August issues of the Journal of the National Cancer Institute, researchers at Kaiser Permanent have concluded that combination (estrogen plus progestin) therapy does increase the risk of breast cancer. Reviewing histories of over 7000 women diagnosed with invasive breast cancer and treated at Kaiser Permanente between 1980 and 2006, the researchers were able to demonstrate a 26 per cent increase in breast cancer between the 1980’s and the 1990’s and an additional 15% increase between 1992 through 2002- as a result of increases in the rates of mammogram and in the use of hormone replacement therapy. But a staggering drop in breast cancer was first noted in 2003—just when patients began discontinuing hormone use following the results of the landmark Women’s Health Initiative in 2002, which found elevated risks of cancer and strokes in women using hormone therapies. As reported in the July 24, 2007 issue of the Washington Post at (http://www.washintonpost.com/wp-dyn/content/article/2007/07/24/AR2007072401571.htm;?sub=new)

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Ashkin Law Firm
Roberta Ashkin, Esq.
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