I thought Nick’s response warranted reposting here. In the spirit of full disclosure, Nick Batik is my husband and partner in Pleiades Publishing Services and the designer of the Iconic Woman and  Holy Hormone sites.

Gardasil, By The Numbers

I view the question of Gardasil more from and economic prospective:

US 2000 Census places girls age 10-14 at 6.9% of the total female population of 151,627,727.
That would be 10,462,313 girls.

Gardasil is currently on the market for $120 per single dose. Three doses are required over a 6-month period, making the total cost for the HPV vaccine $360. On top of that, some doctors are charging office visit fees when the vaccine is given.

That would be a total expenditure of $3,766,432,680 not including office visits. In your article you state that 11,070 cases of cervical cancer were reported in the US. Assuming that 100% of those could be prevented by Gardasil (which it cannot – it only affect 4 of the 72 variations) that would be a cost per case of $340,238.

If you look at the 11,070 reported cases, 3,870 resulted in death. If you measure the cost of Gardasil based on the lives saved (again assuming 100% save rate), that would be $973,238 spent per life. It should be noted that 7,200 (65%) did not die, and that had nothing to do with Gardasil.

Recent congressional reports indicate that an increasing number of cancer related deaths are due to “lack of access” to health care, as opposed to the failures of current treatments. The relatively high cost of the vaccine is just as much a barrier to the poor and uninsured – those most at risk.

The World Health Organization states that there are a number of low-cost, highly effective diagnostic screening options (e.g. PAP test – avg. $27 USD*) and that cervical cancer is one of the most treatable (with access to health care).
*NOTE:  Using PAP Test Recommended guidelines for most women from:
http://www.womenshealth.gov/faq/pap-test.cfm#pap04

• If you are younger than 30 years old, you should get a Pap test every year.
• If you are age 30 or older and have had 3 normal Pap tests for 3 years in a row, talk to your doctor about spacing out Pap tests to every 2 or 3 years.
• If you are ages 65 to 70 and have had at least 3 normal Pap tests and no abnormal Pap tests in the last 10 years, ask your doctor if you can stop having Pap tests.

It would be a reasonable expectation for a woman to have 25 PAP test throughout her lifetime. At $27 USD per test, a woman would invest $675 USD for a life time cervical cancer prevention plan.

Lets be real clear here — even with the Gardasil HPV vaccine the current medical direction is to continued with your regular PAP test schedule. So why risk the possible side effects of the vaccine?

One great unanswered question: increasing outbreaks of diseases though to be eradicated or under control has shown that the efficacy of inoculations given to school age children diminishes over time. Since cervical cancer does not manifest in most women until after age 40, will the Gardasil treatment still be effective, or will it need to administered again?

Considering the number of high-death rate diseases, is this REALLY the best use of our limited health care resources?

Resources:
http://factfinder.census.gov/servlet/STTable?_bm=y&-geo_id=01000US&-qr_name=ACS_2007_3YR_G00_S0101&-ds_name=ACS_2007_3YR_G00_

©2012 An Inconvenient Woman. All Rights Reserved.

In June of 2006, my writing partner, Leslie Botha, and I, started writing articles cautioning women against the use of Gardasil® for girls and young women. We cited the limited nature of the clinical trials (the number, and ages of women tested) and the length of time from the clinical trials and the FDA approval; which in our opinion precluded a reasonable amount of time to follow-up for adverse reaction to the injection.

The RUSH-TO-APPROVAL, combined with MERCK’s, MEGA-Money State and Federal legislative-lobbying efforts, made us very nervous. Anytime a State or Federal agency mandates the use of a vaccine, the manufacturer is essentially, held harmless. That means adverse reaction victims cannot sue them directly. MERCK gets hide behind the shield of the very government agencies WE pay to protect us.

In our articles, Leslie and I cited European researchers who questioned not only the efficacy of the HPV vaccination plan, but the cost effectiveness of what could be one of the largest transfers of public money to private industry in history. With early detection, cervical cancer can be successfully treated; and the best early detection tool is the inexpensive, easily attainable PAP test.

“In developed countries, Pap smear screening and treatment have effectively reduced cervical cancer death rates to very low levels already. There are 3,600 deaths annually from cervical cancer in the United States, 1,000 in France and 400 in Britain.”

Each of those women were mothers, daughters and sisters, and very dear to their families. Most of the deaths were a result of lack of access to preventive medical care. The poor and uninsured can’t get a $30 PAP test, but our public heath officials think its justifiable to mandate BILLIONS of dollars to inoculate young girls with a vaccine that could do more harm than good.

MERCK has sold $1.5 BILLION worth of Gardasil® vaccine in less than two years. Those Gardasil® sales are saving their Vioxx-ravaged balance sheet. How many PAP tests would that amount provide women who have limited, or no, access to preventative care? If the safety of young girls doesn’t make you want to take action and stop this madness, how about cost-effect, use of limited health care resources?

Breast cancer kills hundreds of thousands of women every year…and the numbers are rising. Would 1.5 BILLION dollars be better spent on breast cancer research? We think so.

Spending 1.5 billion on Gardasil®, chasing the ghost of “possible cancer” in the distant future, is not good stewardship of time, talent and treasure — unless you own MERCK stock.

Two years ago Leslie and I sent information to major media outlets, asking that they at least investigate the possibility that HPV vaccines might not be effective or safe for young girls.

We felt like the mythical Cassandra…no one was interested in the news.

To date, there have been 17-deaths and thousands of reported hospitalizations of previously healthy young women and girls. As adverse reactions started to be recorded to the NVIC database, investigative reporters began questioning the HPV vaccine’s safety and cost-effectiveness. Harvard just published a “Follow the Money” report delineating the cost benefit of the mostly, publicly, funded HPV-vaccination initiative.

In the fall of 2006, using published US census data, Leslie and I estimated the number of targeted girls and women (nine to twenty-six year old) and the reported cost of the series of three of the Gardasil® inoculation and estimated the cost to public health budgets. I was sure some bean counter in the bowls of MERCK had preformed the same calculations, with far better resources, when determining the Lobbying budget that got Gardasil® approved.

I wish I could say, we are please to report that with about 20-hrs work, an old calculator and a new MAC laptop we came within a $60K of the Harvard study; but it is actually kind of depressing. All it proves is that we need more inconvenient women, asking more questions, more often, with greater insistence.

Excerpt of Harvard Study

“The vaccines, which require three shots for a complete series, cost about $400 to about $1,000, depending on the country and the fees for doctors’ visits. Unlike older vaccines that save money by preventing costly disease, these vaccines cost health systems money.

The Harvard study concluded that giving the vaccine to 12-year-olds would cost $43,600 for every “quality adjusted year of life” it saved by preventing a cancer death; that price would often be considered acceptable by health officials in wealthy countries, experts say.

But if the vaccine were given to all girls and women up to age 21, the cost per year of life saved would be far higher — $120,400, the Harvard study concluded. And if the vaccines prove to require a booster shot, as many critics believe, that cost rises to $140,000. In such cases it might make more economic sense to rely on Pap smear screening alone, the researchers said.”

Read the full text of following NY Times article.

Email the links to as many women, and health professions as you can.

Inconvenient Women take ACTION!

Click here for the full ELISABETH ROSENTHAL’s NY Times article on Gardasil®, Published: August 20, 2008

“Two vaccines against cervical cancer are being widely used without sufficient evidence about whether they are worth their high cost or even whether they will effectively stop women from getting the disease, two articles in this week’s New England Journal of Medicine conclude.”

“The two vaccines, Gardasil by Merck Sharp & Dohme and Cervarix by GlaxoSmithKline, target two strains of the virus that together cause an estimated 70 percent of cervical cancers. Gardasil also prevents infection with two other strains that cause some proportion of genital warts. Both vaccines have become quick best sellers since they were licensed two years ago in the United States and Europe, given to tens of millions of girls and women.

“Despite great expectations and promising results of clinical trials, we still lack sufficient evidence of an effective vaccine against cervical cancer,” Dr. Charlotte J. Haug, editor of The Journal of the Norwegian Medical Association, wrote in an editorial in Thursday’s issue of The New England Journal. “With so many essential questions still unanswered, there is good reason to be cautious.”

In her article, Dr. Haug points out the vaccines have been studied for a relatively short period — both were licensed in 2006 and have been studied in clinical trails for at most six and a half years. Researchers have not yet demonstrated how long the immunity will last, or whether eliminating some strains of cancer-causing virus will decrease the body’s natural immunity to other strains.

More to the point, because cervical cancer develops only after years of chronic infection with HPV, Dr. Haug said there was not yet absolute proof that protection against these two strains of the virus would ultimately reduce rates of cervical cancer — although in theory it should do so.

Both vaccines target the human papillomavirus, a common sexually transmitted virus that usually causes no symptoms and is cleared by the immune system, but which can in very rare cases become chronic and cause cervical cancer”

For more information read:

The Evidence Gap: Drug Makers’ Push Leads to Cancer Vaccines’ Rise (August 20, 2008)

Send these links out to anyone who cares about the health issues of women and girls!

Inconvenient Women do not get angry…We get ACTIVE!!

©2012 An Inconvenient Woman. All Rights Reserved.

As Big Phama lobbies “Your” Congressional representatives to “control” the American public’s access to natural, “food-based” supplements it is probably a good thing to review the “LAW” that has been in place since 1994. Recently Congress has shown an alarming propensity to write new law instead of adequately enforcing existing legislation. Today’s food supply is often chemically compromised. The average Western diet is comprised of over-processed foods that simply do not meet the nutritional requirements of healthy cell regeneration.

If you take ANY type of nutritional supplement, be an informed consumer. If you feel having a natural alternative to the “Better Living True Chemistry” solution being currently lobbied to “your” congressional representative is important, do something. Read the current legislation (see below) and contact your representatives and let them know how you feel. Big Pharma has had its way with Congress because, for the most part the average American does not pat attention to the posturing and preening until our “personal ox is gored”.

Inconvenient women get informed, take a stand, and GET Active!

Remind your representative that her or she needs your vote, more than they need Big Pharma campaign contribution.

U. S. Food and Drug Administration

Center for Food Safety and Applied Nutrition

December 1, 1995

DIETARY SUPPLEMENT

HEALTH AND EDUCATION ACT OF 1994

For decades, the Food and Drug Administration regulated dietary supplements as foods, in most circumstances, to ensure that they were safe and wholesome, and that their labeling was truthful and not misleading. An important facet of ensuring safety was FDA’s evaluation of the safety of all new ingredients, including those used in dietary supplements, under the 1958 Food Additive Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act). However, with passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), Congress amended the FD&C Act to include several provisions that apply only to dietary supplements and dietary ingredients of dietary supplements. As a result of these provisions, dietary ingredients used in dietary supplements are no longer subject to the premarket safety evaluations required of other new food ingredients or for new uses of old food ingredients. They must, however, meet the requirements of other safety provisions.

Signed by President Clinton on October 25, 1994, the DSHEA acknowledges that millions of consumers believe dietary supplements may help to augment daily diets and provide health benefits. Congress’s intent in enacting the DSHEA was to meet the concerns of consumers and manufacturers to help ensure that safe and appropriately labeled products remain available to those who want to use them. In the findings associated with the DSHEA, Congress stated that there may be a positive relationship between sound dietary practice and good health, and that, although further scientific research is needed, there may be a connection between dietary supplement use, reduced health-care expenses, and disease prevention.

The provisions of DSHEA define dietary supplements and dietary ingredients; establish a new framework for assuring safety; outline guidelines for literature displayed where supplements are sold; provide for use of claims and nutritional support statements; require ingredient and nutrition labeling; and grant FDA the authority to establish good manufacturing practice (GMP) regulations. The law also requires formation of an executive level Commission on Dietary Supplement Labels and an Office of Dietary Supplements within the National Institutes of Health.

These specific provisions of the DSHEA are synopsized below.

DEFINITION OF DIETARY SUPPLEMENT

FDA traditionally considered dietary supplements to be composed only of essential nutrients, such as vitamins, minerals, and proteins. The Nutrition Labeling and Education Act of 1990 added “herbs, or similar nutritional substances,” to the term “dietary supplement.” Through the DSHEA, Congress expanded the meaning of the term “dietary supplements” beyond essential nutrients to include such substances as ginseng, garlic, fish oils, psyllium, enzymes, glandulars, and mixtures of these.

The DSHEA established a formal definition of “dietary supplement” using several criteria. A dietary supplement:

• is a product (other than tobacco) that is intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients.
• is intended for ingestion in pill, capsule, tablet, or liquid form.
• is not represented for use as a conventional food or as the sole item of a meal or diet.
• is labeled as a “dietary supplement.”
• includes products such as an approved new drug, certified antibiotic, or licensed biologic that was marketed as a dietary supplement or food before approval, certification, or license (unless the Secretary of Health and Human Services waives this provision).

SAFETY

The DSHEA amends the adulteration provisions of the FD&C Act. Under DSHEA a dietary supplement is adulterated if it or one of its ingredients presents “a significant or unreasonable risk of illness or injury” when used as directed on the label, or under normal conditions of use (if there are no directions). A dietary supplement that contains a new dietary ingredient (i.e., an ingredient not marketed for dietary supplement use in the U.S. prior to October 15, 1994) may be adulterated when there is inadequate information to provide reasonable assurance that the ingredient will not present a significant or unreasonable risk of illness or injury. The Secretary of HHS may also declare that a dietary supplement or dietary ingredient poses an imminent hazard to public health or safety. However, like any other foods, it is a manufacturer’s responsibility to ensure that its products are safe and properly labeled prior to marketing.

LITERATURE

The DSHEA provides that retail outlets may make available “third-party” material s to help inform consumers about any health-related benefits of dietary supplements. These materials include articles, book chapters, scientific abstracts, or other third-party publications. These provisions stipulate that the information must not be false or misleading; cannot promote a specific supplement brand; must be displayed with other similar materials to present a balanced view; must be displayed separate from supplements; and may not have other information attached (product promotional literature, for example).

NUTRITIONAL SUPPORT STATEMENTS

The DSHEA provides for the use of various types of statements on the label of dietary supplements, although claims may not be made about the use of a dietary supplement to diagnose, prevent, mitigate, treat, or cure a specific disease (unless approved under the new drug provisions of the FD&C Act). For example, a product may not carry the claim “cures cancer” or “treats arthritis.” Appropriate health claims authorized by FDA–such as the claim linking folic acid and reduce risk of neural tube birth defects and the claim that calcium may reduce the risk of osteoporosis–may be made in supplement labeling if the product qualifies to bear the claim. Under DSHEA, firms can make statements about classical nutrient deficiency diseases–as long as these statements disclose the prevalence of the disease in the United States. In addition, manufacturers may describe the supplement’s effects on “structure or function” of the body or the “well-being” achieved by consuming the dietary ingredient. To use these claims, manufacturers must have substantiation that the statements are truthful and not misleading and the product label must bear the statement “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” Unlike health claims, nutritional support statements need not be approved by FDA before manufacturers market products bearing the statements, however, the agency must be notified no later than 30 days after a product that bears the claim is first marketed.

INGREDIENT AND NUTRITION INFORMATION LABELING

Like other foods, dietary supplement products must bear ingredient labeling. This information must include the name and quantity of each dietary ingredient or, for proprietary blends, the total quantity of all dietary ingredients (excluding inert ingredients) in the blend. The label must also identify the product as a “dietary supplement” (e.g., “Vitamin C Dietary Supplement”). Labeling of products containing herbal and botanical ingredients must state the part of the plant from which the ingredient is derived. If a supplement is covered by specifications in an official compendium and is represented as conforming, it is misbranded if it does not conform to those specifications. Official compendia include the U.S. Pharmacopeia, the Homeopathic Pharmacopeia of the United States, or the National Formulary. If not covered by a compendium, a dietary supplement must be the product identified on the label and have the strength it is represented as having.

Labels also must provide nutrition labeling. This labeling must first list dietary ingredients present in “significant amounts” for which FDA has established daily consumption recommendations, followed by dietary ingredients with no daily intake recommendations. Dietary ingredients that are not present in significant amounts need not be listed. The nutrition labeling must include the quantity per serving for each dietary ingredient (or proprietary blend) and may include the source of a dietary ingredient (for example, “calcium from calcium gluconate”). If an ingredient is listed in the nutrition labeling, it need not appear in the statement of ingredients. Nutrition information must precede ingredient statements on the product label.

NEW DIETARY INGREDIENTS

Supplements may contain new dietary ingredients–those not marketed in the United States before October 15, 1994–only if those ingredients have been present in the food supply as an article used for food in a form in which the food has not been chemically altered or there is a history of use, or some other evidence of safety exists that establishes that there is a reasonable expectation of safety when the product is used according to recommended conditions of use. Supplement manufacturers must notify FDA at least 75 days before marketing products containing new dietary ingredients, providing the agency with the information on which the conclusion that a dietary supplement containing the new dietary ingredient “will reasonably be expected to be safe” was based. Any interested party, including a manufacturer of a dietary supplement, may petition FDA to issue an order prescribing the conditions of use under which a new dietary ingredient will reasonably be expected to be safe.

GOOD MANUFACTURING PRACTICES (GMPs)

DSHEA grants FDA the authority to establish GMP regulations governing the preparation, packing, and holding of dietary supplements under conditions that ensure their safety. These regulations are to be modeled after current good manufacturing practice regulations in effect for the rest of the food industry. FDA intends to work with the supplement industry and other interested persons to develop GMPs and, in doing so, will seek public comment as to their scope.

COMMISSION ON DIETARY SUPPLEMENTS

The DSHEA requires the formation of a Commission to conduct a study and make recommendations on the regulation of label claims and statements for dietary supplements and procedures for the evaluation of the claims. The members of the Commission will evaluate how best to provide truthful, scientifically valid, and not misleading information to consumers so that they can make informed and appropriate health care choices. The Commission will be composed of seven members, appointed by the President, with experience in dietary supplements and in the manufacture, regulation, distribution, and use of supplements. Three members must be qualified by scientific training and experience to evaluate supplements’ health benefits, and one of these must be trained in pharmacognosy, medical botany, traditional herbal medicine, or other related sciences. All Commission members and staff should be unbiased about supplement use.

On October 2, 1995, the White House announced the names of the seven individuals the President intends to appoint to the Commission. The members include nutritionists, industry representatives, a pharmacognosist, and attorneys.

The Commission will submit a final report including recommendations and legislation related to label claims for dietary supplements to the President and Congress within two years of convening.

OFFICE OF DIETARY SUPPLEMENTS

The HHS Secretary will establish an office within the National Institutes of Health to explore the potential role of supplements to improve health care in the U.S. The office will also promote scientific study of supplements and their value in preventing chronic diseases; collect and compile scientific research, including data from foreign sources and the NIH Office of Alternative Medicine; serve as a scientific adviser to HHS and FDA; and compile a database of scientific research on supplements and individual nutrients.

EFFECTIVE DATE

DSHEA’s provisions for use of nutritional support statements and third-party literature became effective when the law was signed. The effective date for other labeling provisions and any FDA implementing regulations is after December 31, 1996, although manufacturers may label their products consistent with provisions of DSHEA until that date.

©2012 An Inconvenient Woman. All Rights Reserved.

Since when has natural health been a crime?

As if the present war on natural health alternatives wasn’t enough, GlaxoSmithKline Consumer Healthcare (GSK), is now petitioning the FDA to determine that dietary supplements claiming to promote, assist or otherwise help with any aspect of weight loss are “disease claims,” and thereby unlawful. U.K. based GSK is conveniently the manufacturer of Alli, the OTC version of the drug orlistat.

Alli, whose website advises consumers: “until you have a sense of any treatment effects, it’s probably a smart idea to wear dark pants and bring a change of clothes with you to work,” exhibits ghastly side effects which include “oily spotting on underwear” and “inability to control stool (incontinence)”. Despite its promising $153.5 million profit during its first two weeks on the market, only a year after its release, excitement is dwindling and sales have slowed. “We know it’s selling very well,” said Brian Jones, a GlaxoSmithKline spokesman who declined to share any specific numbers. “But we don’t know if it’s going to last” (MSNBC 7-07).

Clearly GSK’s “Citizen” Petition Requesting FDA to Treat Weight Loss Claims for Dietary Supplements as Disease Claims is nothing more than a desperate attempt to make it last, by virtually monopolizing the non-prescription weight management products market. Evidently GSK is attempting to make its brainchild, Alli, the sole non-prescription product available to help with weight management. Individuals need to become aware of this debilitating and blatant abuse of power.

For the past several decades, the FDA has correctly viewed claims referencing weight loss as permissible structure/function claims, resting on the sound logic that the body’s ability to gain and lose weight is not a disease. According to GSK’s logic, however, sound scientific structure/function claims should now be interpreted as disease claims. The GSK mistakenly argues that current structure/function claims are misleading consumers into believing these products will both prevent and cure diseases, and that they are FDA approved. The truth of the matter is that the vast majority of supplement manufacturers are well in keeping with the numerous regulations that govern the dietary supplements market, many of which include the statement “This product is not intended to treat, cure, prevent or diagnose any disease” on all labels.

Part of GSK’s argument is that being overweight is a risk factor for disease. They then point to precedents whereby the FDA regards cholesterol level, blood pressure and glucose level related structure/function claims as disease claims. However, this analogy is inapplicable. Consumers taking products to control cholesterol, blood pressure and blood sugar are predominantly concerned with affecting specific diseases, namely heart disease, hypertension and diabetes. On the other hand, people seeking to lose weight primarily wish to improve overall health and appear more attractive. In fact, according to a new survey by Cancer Research UK, the vast majority of people rate looking good over reducing the risk of body fat as a reason to maintain a healthy weight.

While some studies suggest that many people attempt to lose weight for health reasons, those studies that have specifically investigated ‘prevention of a disease’ as a motive for dieting or weight loss have all found disease prevention to be a minor motivation as compared with improvement of general health and cosmetic appearance. Promoting general health is not equivalent to the treatment of a disease. And clearly, neither is improving cosmetic appearance. Every applicable study published on the subject is consistent with the fact that these two motivations for weight loss account for over 80% of the reasons people have for attempting to lose or control body weight. Thus, disease prevention or treatment, is clearly not a major motivator for weight loss or weight management.

Obviously, very few people are interested in losing weight to prevent or treat a disease. So who are these citizens behind GSK’s so-called “Citizen’s” petition? Where are the people who feel they’re being misled by safe and ethical foods and supplements, intended to support or assist weight loss efforts? Who feels misled that weight loss supplements should have prevented or treated their diseases? The answer is nobody. Nobody sees dietary supplements as a cure or treatment for heart disease, diabetes, obesity or any disease for that matter. The petition is brought to the FDA by the might of GlaxoSmithKlein, and not by misled consumers or citizens. Its sole purpose is to improve Alli sales.

Even simple observation shows us that weight loss supplements appeal to consumers’ personal vanity, not to their desire to prevent a disease. What’s more, none of the studies cited in the GSK petition address actual consumer perceptions or expectations of weight loss products. Therefore, while consumers may very well feel that a weight loss related supplement may help to reduce body weight, it has yet to be shown that consumers expect such supplements to mitigate, treat, cure or prevent any disease.

Ever since the Dietary Supplement Health Education Act (DSHEA) passed in 1994, the American people have insisted in no uncertain terms, that they demand their God-given right to buy dietary supplements. Though the GSK petition suggests that individuals are incapable of making the decisions necessary for their own health and well-being, belittling consumer intelligence, people know that good health requires individuals to be fully informed. Long before profit-driven pharmaceutical companies with vested interests even existed, human beings were using herbal remedies and other natural products to supplement their health. Now, because major pharmaceutical companies are putting a price tag where integrity should exist, basic health freedoms are once again in jeopardy.

Losing weight is one of the most basic and prevalent of modern human desires–so many of us wish to look and feel better, healthfully. If GSK’s flawed prerogative is accepted by the FDA, the state of natural health will become alarmingly vulnerable. And, if this callous attempt to usurp our intrinsic right to take control of our own health is permitted, what’s next? Where will the line be drawn? Will citizens be forced to buy expensive prescriptions where they would once have purchased a simple herb, food or vitamin? And what of the hard-working citizens without the benefits of health insurance? How, then, will these people afford to supplement their health?

Every human being has the right to live a healthy life, and a responsibility to create that health for him- or herself. This heinous petition suggests that individuals should not be in charge of their own health—rather, that health decisions should rest solely in the hands of profit-driven megaliths. It implyies that only those who can afford to purchase costly prescriptions and potentially hazardous OTC drugs have the right to a healthy life. It has never been more important to protect your health freedom rights from the greedy activities of Big Pharma.

Consumers must become conscious of this gross violation of their health freedoms. Help protect your own health rights, and the rights of your fellow citizens by writing to the FDA and telling them why you think GSK’s ‘Citizen’ Petition to Treat Weight Loss Claims for Dietary Supplements as Disease Claims is an offensive violation of your health freedoms. It’s time to fight for your health. After all, if you don’t do it—who will?

To join with other people who feel as you do, become a member of the Nutritional Health Alliance (NHA) health freedom advocacy group. For the sake of health freedom, join the NHA today!

• Sign up here for free weekly updates from NHA!

Reprinted with permission: Nutritional Health Alliance (NHA)

©2012 An Inconvenient Woman. All Rights Reserved.

Synthetic drug treachery has plummeted to a new ethical low with a disturbing development that may grant Big Pharma eternal immunity from consumer lawsuits. This most recent affront to justice involves a birth-control drug with side effects believed to have caused the deaths of 40 women, along with thousands of additional heart attacks and strokes. About 3,000 women subsequently united in a class-action lawsuit against the birth-control drug manufacturer. As the lawsuit takes shape in an Ohio federal court, this drug maker has taken a position that is a staggering example of Big Pharma’s bottomless greed and nonexistent morality.

Thanks to a legal concept called pre-emption, approved by the US Supreme Court earlier this year, the birth control manufacturer has a strong defense against the lawsuit: Since the FDA approved the drug, the pharmaceutical manufacturer that created the drug claims it should not be held liable for any of the deaths, heart attacks, strokes or other maimings the drug may have caused. Shockingly, legal experts believe this defense might be bulletproof—setting up a distressing potential precedent where Big Pharma may never be held accountable for the dangerous synthetic drugs it unleashes on an unsuspecting public.

Dangerous Deceit

How did this travesty happen in the first place? The estrogen used in birth-control drugs, when delivered at levels that are too high, carries the risk of provoking blood clots—which in turn cause strokes and heart attacks. The birth-control drug named in the lawsuit, which comes in the form of a patch, was marketed as a way to deliver less estrogen than a pill while still remaining effective. The FDA approved this patch in 2001.

The truth came out years later: An independent organization found that the patch in question delivered more estrogen—not less— than its pill counterparts. The patch’s manufacturer was well aware of the dangers associated with high estrogen levels. Unfazed, they not only submitted the drug to the FDA for approval, but deceptively labeled it as having a much lower level of estrogen than was actually the case. After four years on the market and thousands of serious adverse events reported—including deaths—the FDA finally issued a formal warning about the birth-control patch.

Drug Déjà Vu

Does this scenario sound ominously familiar? It is, to quote Yogi Berra, déjà vu all over again: A dangerous drug is released to the public, thousands of people are injured or killed as a result of taking it and then the FDA issues its warning—far too late for those who have been devastated by horrible side effects. Despite its now-legendary drug approval failures— and despite its thinning resources—the FDA has inexplicably decided to continue focusing a great deal of its regulatory energy on the one arena that’s promoting health without dangerous side effects: nutritional supplements.

So how do you feel about Big Pharma’s refusal to take responsibility for its dangerous medications? Has your confidence in the FDA’s drug-approval process faltered? Speak your mind and make your voice heard! Tell your elected officials that you want the FDA to leave nutritional supplements alone and instead focus its regulatory resources on Big Pharma! Rage against the preemption that may enable Big Pharma to release dangerous drugs without fear of repercussions!

In addition, patronize independent natural health food stores and purchase safe, natural nutritional supplements from companies that have no pharmaceutical industry ties.

Source: The Nutritional Health Alliance (Reprinted with permission)

The Nutritional Health Alliance is one of the most active political organizations in the nutritional health community, founded in 1992 in Santa Ynez, California. Organized by consumers, health care professionals, retailers, distributors, supplement manufacturers, mail order and multilevel marketing firms, and industry trade and consumer publications, the NHA became the much-needed umbrella organization to bring together the various constituents of the natural products industry in a single, powerful voice that would be heard by Washington policymakers and regulators.

There is plenty you can to do get involved and support the NHA. Join NHA now and communicate on NHA forum, browse through the NHA PDF Library, view the NHA press and videos or search NHA’s related links to gain further knowledge on laws that affect your rights to buy vitamins and supplements.

Let your voice be heard, write to your Congressperson or view NHA current activities to find out ways to keep your right to buy vitamins in your own hands… Don’t let Congress and the FDA take your vitamins away!

For the sake of health freedom, join the Nutritional Health Alliance (NHA) health freedom advocacy group today!

©2012 An Inconvenient Woman. All Rights Reserved.

The furor of the FDA’s rapid approval of Merck HPV Vaccine (Gardasil) and the ‘pre/post vaccine approval’ marketing and legislative blitzkrieg by Merck is now turning into jaw-dropping sticker-shock.

The cost of ‘immunizing’ over 21 million sixth-grade girls in the United States today, at $360 for a three-shot series — is not millions of dollars but billions of dollars in profit for the Merck Pharmaceutical Company. Money that will come from Medicaid, Fed/State funded children’s insurance programs. This will be one of the larges transfers of capital from public to private hands in history. This HPV Vaccine program is moving on greased skids, without a whole lot of intelligent questioning from our elected or regulatory “representatives”.

Ignoring the fact we are trusting our daughter’s uteruses to the same company that brought us Vioxx — let us just take a moment and look at the relative threat a woman faces from Breast cancer vs. Cervical cancer. My thoughts are, that our money (and no matter what our State and Federal legislators think — it is our money they are spending) should be focused on the greatest threat… and that threat is certainly not Cervical cancer.

How Many Women Get Breast Cancer?

Breast cancer is the most common cancer among women in the United States, other than skin cancer. It is the second leading cause of cancer death in women, after lung cancer.

About 182,460 women in the United States will be found to have invasive breast cancer in 2008. About 40,480 women will die from the disease this year. Right now there are about two and a half million breast cancer survivors in the United States.

The chance of a woman having invasive breast cancer some time during her life is about 1 in 8. The chance of dying from breast cancer is about 1 in 35. Breast cancer death rates are going down. This is probably the result of finding the cancer earlier and improved treatment.

Compared To How many women will get Cervical Cancer

In 2007 there will be about 3,670 deaths from cervical cancer in the United States, and the vast majority of these cases will be in patients who have never had a PAP test, or cervical screening. According to the latest U.S. Census Bureau, there are approximately 301,718,307 people in the United States, and about half of those are women (150,859,152). Statistically speaking the death rate due to cervical cancer is approx 0.002% or 1 in 50,000.

Source: American Cancer Society

U.S. Census Bureau

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The United States continues to spend more on health than any other industrialized country.

Major payers for health care include public programs such as Medicare and Medicaid, and private health insurers such as health maintenance organizations and other managed care entities.

In 2003 national health care expenditures in the United States totaled $1.7 trillion, a 7.7 percent increase compared with about 9 percent per year increases in 2001 and 2002. In the mid-1990s annual growth had slowed somewhat, following an average annual growth rate of 11 percent during the 1980s.

The United States spends a larger share of the gross domestic product (GDP) on health than does any other major industrialized country.

In 2002 the United States devoted 15 percent of the GDP to health compared with 11 percent each in Switzerland and Germany and nearly 10 percent in Iceland, France, Canada, Norway, and Greece, countries with the next highest shares.

In 2003 national health expenditures grew 7.7 percent, compared with 4.9 percent growth in the gross domestic product (GDP). Health expenditures as a percent of the GDP increased to 15.3 percent in 2003, up from 14.9 percent

in 2002.

In 2004, the increase in the medical care component of the Consumer Price Index (CPI) was 4.4 percent, continuing to outpace overall inflation (2.7 percent). The CPI for hospital services showed the greatest price increase (6.0 percent) compared with other components of medical care.

Expenditures by Type of Care and Source of Funds

In recent years expenditures for prescription drugs have grown at a faster rate than any other type of health expenditure. Hospital care, however, continues to account for the largest share of health care spending.

Expenditures for hospital care accounted for 31 percent of all national health expenditures in 2003.

Physician services accounted for 22 percent of the total in 2003.

Prescription drugs accounted for 11 percent,

and nursing home care for 7 percent

Between 2000 and 2003 community hospital expenses increased at an average annual rate of 8 percent comparedwith a 5-percent increase between 1995 and 2000.

Between 1995 and 2003 the average annual rate of increase for prescription drug expenditures was 14 percent, higher than for any other health expenditure

Prescription drug expenditures increased 11 percent in 2003 and 15–16 percent in 2001 and 2002. Prescription drugs posted a 3-percent increase in the Consumer Price Index in 2003 and 2004 and a 5-percent price increase in 2001 and 2002.

In 2003, 46 percent of prescription drug expenditures were paid by private health insurance (up from 24 percent in 1990), 30 percent by out-of-pocket payments (down from 59 percent in 1990), and 19 percent by Medicaid.

Although Medicare is the Federal program that funds health care for persons age 65 years and over, and older Americans are the highest per capita consumers of prescription drugs, Medicare paid less than 2 percent of prescription drug expenses in 2003.

In 2002, 91 percent of persons age 65 years and over in the civilian non-institutionalized population had a prescribed medicine expense compared with 61 percent of younger people. Women 65 years of age and over averaged $920 out-of-pocket for prescribed medicine compared with $674 for men in 2002. Among those under 65 years of age, out-of-pocket expenses averaged $265 for women and $212 for men in 2002.

In 2002, 96 percent of persons age 65 years and over in the civilian non-institutionalized population reported medical expenses that averaged about $7,800 per person with expense. Seventeen percent of expenses were paid out-of-pocket, 14 percent by private insurance, and 66 percentby public programs (mainly Medicare and Medicaid).

The burden of out-of-pocket expenses for health care varies considerably by age. In 2002 about two-fifths of those 65 years of age and over with health care expenses paid $1,000 or more out-of-pocket, compared with one-quarter of those 45–64 years of age, and less than one-ninth of adults 18–44

years of age.

In 2003, 33 percent of personal health care expenditures were paid by the Federal Government and 11 percent by State and local government; private health insurance paid 36 percent and consumers paid 16 percent out-of-pocket

Enrollment in HMOs totaled 69 million persons or 23 percentof the U.S. population in 2004. HMO enrollment varied from16–19 percent in the South and Midwest to 30–34 percent in the Northeast and West. HMO enrollment increased steadily through the 1990s but has declined since then. Between 1998 and 2004 the number of HMO plans decreased from 651 to 412 plans.

In 2003 the major sources of funds for hospital care were Medicare (30 percent) and private health insurance (34 percent).

Physician services were also primarily funded by private health insurance (one-half) and Medicare (one-fifth). In contrast, nursing home care was financed primarily by Medicaid (almost one-half) and out-of-pocket payments (more than one-quarter). The Medicare share of nursing home expenditures has risen from 3 percent in 1990 to 12 percent in 2003.

Publicly Funded Health Programs

The two major publicly funded health programs are Medicare and Medicaid.

Medicare is funded through the Federal Government and covers the health care of persons 65 years of age and over and disabled persons.

Medicaid is jointly funded by the Federal and State Governments to provide health care for certain groups of low-income persons. In recent years, Medicaid has expanded to cover a greater proportion of the low-income adult population—and the State Children’s Health Insurance Program (SCHIP) now covers many low-income children. Medicaid benefits and eligibility vary by State.

In 2004 the Medicare program had 42 million enrollees and expenditures of $309 billion.

In 2004 hospital insurance (HI) accounted for 55 percent of Medicare expenditures. Expenditures for home health agency care continued to hover around 3 percent of HI expenditures, down from 14 percent in 1995. Expenditures for hospice care nearly doubled from 2 to 4 percent of HI expenditures between 2000 and 2004.

Source: Health, United States, 2005, page 15

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