In the early 1990s, faced with protests by AIDS activists about the glacier-like approval of potential life saving drugs, the Clinton administration changed the FDA drug approval process. They allowed pharmaceutical companies to “fast track life-saving” drugs by absorbing the extra costs involved. The unintended consequence of this humanitarian intention became “Safety for Sale”. The number of product recalls in the past 15-years is enough to turn the most trusting advocate of governmental infallibility into a stone, cold, cynic.

Successive administrations have unsuccessfully struggled with more than one “Drug-War”. If the American public were truly aware of the actual body count that has resulted from BIG PHARMA’s policy of ‘profit over accountability’, they would be marching in the streets. Maybe the people who demanded the networks show the flag draped coffins of fallen soldiers, so the public would become more aware of the very human cost of war, had the right idea.

The young people who have lost their lives to unsafe, questionably tested, and hastily approved drugs, died without the notice of the national media…one heart-wrenching loss at a time. The bereaved families stand alone at the gravesite; go back to an empty house, and sit in the silence of dreams forever unlived.  Since the beginning of the wars in Afghanistan and Iraq, America has lost more young men and women to fatal adverse medical events than to enemy hostilities.

Maybe the Gardasil® mothers, and the parents of the teens on antidepressants who committed suicide or the parents of kids who were killed by other kids in the grip of drug-induced paranoia, could stand together with the pictures of the children they have lost. It is time to make the country aware of how the ‘profit before safety’ paradigm of BIG PHARMA and its unholy alliance with our erstwhile, ineffective, protector, the FDA, is costing lives and ripping the fabric of the families left behind to grieve and wonder why and what could have been.

Independent journalist, Cynthia Janak, has made a start. She has developed a web site memorial to those young women and girls who have lost their lives to Gardasil®. The site also features stories of the young women who survived, forever changed, by an adverse reaction to the Gardasil® vaccine. Cynthia is taking action. She is giving a voice to the women, who have been beneath the notice of the national media. Cynthia has chosen to stand up, speak out and be a witness.

In the bastions of big money and BIG PHARMA, I’m sure Cynthia is considered a very INCONVENIENT WOMAN indeed.
Please visit http://www.cynthiajanak.com/Gardasil.html and Remember The Names and The Faces of the girls who died for greed and Gardasil®.

©2012 An Inconvenient Woman. All Rights Reserved.

WASHINGTON  The Food and Drug Administration on Friday unveiled a report listing 20 drugs that the agency is investigating for potential side effects, as part of a new policy to warn patients and health-care professionals as early as possible.

The list includes a wide array of drugs, from Eli Lilly & Co. s antidepressant Cymbalta to Purdue Pharma LPs painkiller Oxycontin. It also addresses a range of adverse reactions, including cardiac arrest, cancer and Purple Glove Syndrome, which can result in patients having their arms amputated. (See the FDA s list of drugs that are under investigation.)

The FDA has already sent out warnings about a handful of the drugs on the list. The report lists TNF blockers  such as Johnson & Johnson s Remicade  as being potentially associated with cancer in children. In June, the FDA said it was investigating the possible link. TNF blockers target a compound known as tumor necrosis factor, which is overproduced in many patients with inflammatory diseases like arthritis and Crohn s.

But there appear to be new ones, too. The report lists Biogen Idec Inc. and Elan Corp. s multiple-sclerosis treatment Tysabri as potentially being associated with skin cancer. Medical journals have reported cases of melanoma in patients taking Tysabri, but the FDA hasn t previously said it was investigating the drug for this side effect.

The list, which the FDA will start issuing quarterly, is aimed at giving consumers and health-care professionals early indications of what the FDA is investigating, but it might end up creating more confusion. Indeed, the agency is concerned that people will stop taking a drug inappropriately  because it is on the list, said Paul Seligman, associate director of safety policy at the agency.

The FDA said it alerted companies whose drugs appeared on the list prior to it being made public  several companies said they received word late Thursday  and intends to give drug makers a heads-up in the future as well.

Drug makers said they support the FDA s additional efforts to be transparent about drug safety, but some expressed concern that the information was being communicated to patients without context and wondered about what patients might do with the information.

It is very, very important that patients and their physicians understand the benefits and the risks of the drug. To speak about one without the other could have an impact on patient perception of their medications,  said Tony Jewell, a spokesman for AstraZeneca PLC, whose psychiatric medication Seroquel made the list for the possible safety concern of overdose due to confusing sample-pack labeling.

Companies also cautioned that just because a drug is posted on the site doesn t mean a causal relationship has been identified, and it is also risky if patients go off their medications without consulting a physician.

The FDA s intention is for patients and doctors to use the list to be aware of potential adverse events and to encourage them to report any problems. The list doesn t represent a comprehensive list of drugs the FDA is investigating, the FDA s Mr. Seligman said.

The report is generated from the agency s adverse-event-reporting database. That compilation consists of voluntary reports from patients and health-care professionals, and is widely considered to capture only a fraction of the actual adverse events associated with any given drug.

Mr. Seligman said the FDA is hopeful the quarterly reports will encourage people to report adverse events.

Write to Jared A. Favole at jared.favole@dowjones.co

©2012 An Inconvenient Woman. All Rights Reserved.

It was a hot issue here in Texas a couple of years ago.  Now Gardasil, the vaccine against the virus that causes cervical caner, is back in the spotlight.

Gabi Swank, a 16-year-old from Wichita, Kansas, says she and other girls are dying from the side-effects of the drug.  Once a cheerleader with a 4.0 grade point average, she is now homebound, suffering from seizures, migraines and even two small strokes.

Swank’s doctors diagnosed her with cerebral vasculatis, a terminal disease.  And he blames Gardasil complications.

Now, Swank and her mother are on a mission.

“She looked at me with the most somber face and she said, ‘If I have to die to save other girls, then I am prepared to do that’,” said Gabi’s mother, Shannon Schrag.

“I want this drug off the market,” said Gabi.

Governor Rick Perry made headlines two years ago when he made Texas the first state to require the vaccine against human pappilomavirus (HPV), a sexually transmitted disease.  Conservatives and parents rights groups felt the requirement condoned pre-marital sex.

The makers of Gardasil say the drug is safe.  They’re hoping to vaccinate boys as well.

ABC Affiliate KAKE 10, also carried the story “Lawmaker Wants Answers On Gardasil” and added:

…Twenty-eight women have died, reportedly from the Gardasil vaccination. The FDA says it continues to follow the drug, but it maintains the benefits outweigh the risks.

In 2007, Wichita Representative Delia Garcia introduced a bill that would require all young women to get the HPV vaccination to prevent cervical cancer. Now she wants the FDA to look further into the side effects to make sure it’s safe.

To watch the video that accompanied the story click the following link: http://www.kake.com/health/headlines/39581687.html

©2012 An Inconvenient Woman. All Rights Reserved.

WASHINGTON–(BUSINESS WIRE)–The National Vaccine Information Center (NVIC) is calling on the Centers for Disease Control (CDC) and Food and Drug Administration (FDA) to publicly release the study design, data and names of principal investigators involved in a statement this week maintaining that Gardasil vaccine is safe with no serious side effects. NVIC will also be calling on the newly elected President and members of Congress to remove the nation’s vaccine safety monitoring system from the Department of Health and Human Services (DHHS) and place it in a separate entity reporting directly to Congress to restore trust in the nation’s public health laws based on federal mass vaccination policies.

The CDC and FDA are alleging that the vast majority – if not all – of the approximately 9,000 HPV vaccine adverse events, including 27 deaths, reported to the federal Vaccine Adverse Event Reporting System (VAERS) are not causally related to the Gardasil vaccine based on internal analysis, including review of medical records of girls and women vaccinated in HMO’s participating in the federal Vaccine Safety Datalink (VSD) Project and other closed government operated databases.

“Transparency in government is essential to trust in government and replication is the hallmark of good science,” said NVIC co-founder and president Barbara Loe Fisher. “Parents of young girls and women cut down in their prime – some of them paralyzed or dead within hours or days of getting Gardasil vaccine – deserve better answers than a whitewashing of this vaccine’s very serious side effects. Until there is an independent confirmation of these unverified findings by individuals and companies without financial ties to the government or industry, it is not credible.”

* In June 2006 NVIC questioned the quality and quantity of Merck’s pre-licensure Gardasil vaccine safety data in girls under age 16 and, in 2007, issued three reports analyzing serious Gardasil adverse events reported to VAERS;

* In 2007, Merck lobbied in many states for Gardasil vaccine mandates but failed in most;

* During 2008, about 20 percent of all vaccine adverse event reports to VAERS were related to Gardasil even though it is not a mandated vaccine like most others;

* Last week, reports that Merck’s Gardasil sales are falling dramatically and are not offsetting similar declining sales of other drugs associated with safety concerns prompted Merck to lower profit projections and layoff employees.

NVIC (www.nvic.org) was founded in 1982 and worked with Congress on the 1986 National Childhood Vaccine Injury Act. The non-profit watchdog group advocates for safer vaccine policies and the legal right for Americans to make informed, voluntary decisions about vaccination.

©2012 An Inconvenient Woman. All Rights Reserved.

Levine filed a lawsuit against Wyeth in state court in Vermont over alleged problems with the Phenergan label, and a jury ruled in her favor. The Vermont Supreme Court upheld the decision. In an appeal to the U.S. Supreme Court, Wyeth argued that FDA approval of medication labels precludes lawsuits in state courts filed over alleged problems with the labels (Kaiser Daily Health Policy Report, 10/3).

The current Supreme Court — “one of the most pro-business ones in 50 years,” according to the Journal — in February ruled in favor of pre-emption in a case involving the medical device company Medtronic. In addition, Justice Stephen Breyer in a “testy burst” during a recent drug-related case asked the plaintiff’s lawyer whom she would rather have in charge of whether drugs should be allowed on the market: “an expert agency, on the one hand — or 12 people pulled randomly for a jury role who see before them only the people whom the drug hurt, and don’t see those who need the drug to cure them?” According to the Journal, the Bush administration “has long promoted the idea that federal law pre-empts state lawsuits.”

Comments

Wyeth officials noted that the suit does not allege that the firm knowingly sold a dangerous product and that it complied with FDA guidelines for the drug’s label. In addition, Wyeth officials said that strengthening the label to comply with stricter Vermont law would have been a violation of federal law. Bert Rein, lead outside attorney for Wyeth, said, “It would be a chaotic system if you can relabel anything as long as you mumble safety.” However, Rein said he did not know of any instances where FDA had punished a firm for increasing the emphasis of a warning label.

Levine’s lawyers say federal law is not intended to prevent drugmakers from taking proactive steps to enhance warnings to doctors and consumers. According to the Journal, they say FDA guidelines “are the floor, not the ceiling, when it comes to safety standards.”

Consumer advocates say patients’ ability to sue in state courts is their only defense against corporate misbehavior, such as instances where FDA reviewers make a mistake or firms hide information. The New England Journal of Medicine in August published an editorial in favor of Levine that made similar arguments. Rein said that a ruling in favor of pre-emption would make it more difficult for people harmed by drugs to obtain compensation, but noted that Congress should establish a fund for such patients, as it did for vaccine-related injuries.

Implications

According to the Journal, a ruling in favor of pre-emption could heavily affect the drug industry. Recent cases that would have been affected include a $68 million settlement by Johnson & Johnson over its Ortho Evra contraceptive patch, more than $1 billion in settlements by Eli Lilly over its antipsychotic drug Zyprexa and $4 billion in payments so far by Merck over lawsuits involving its anti-cholesterol treatment Vioxx.

The Journal reports that some Democrats said that if they increase their majority in Congress this election cycle they will propose bills to undo pre-emption and guarantee the ability of patients to sue for damages (Wall Street Journal, 10/27).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

©2012 An Inconvenient Woman. All Rights Reserved.

Dr. Dan Roden is professor of medicine and pharmacology, director of the Oates Institute for Experimental Therapeutics, and assistant vice chancellor for personalized medicine at Vanderbilt University School of Medicine.

The Food and Drug Administration recently announced a public Web site listing potential drug side effects it is investigating. This move does seem to be in the public interest; after all, shouldn’t we know about drug side effects that are concerning enough to warrant an FDA investigation?

On further reflection, this turns out to be a pretty complicated question, and raises important issues about how doctors and patients should evaluate new information about the risks and benefits of drugs we use.

Before a drug is approved for marketing, it is tested in several thousand patients, and common side effects are identified. However, some side effects are only discovered after a drug is marketed. Some of these are so rare they just didn’t happen before a drug was approved. Others don’t turn up until they are identified in large, carefully conducted trials: An increase in heart-attack risk with Vioxx is a recent example.

There is no organized system in the United States, or elsewhere, to systematically examine the safety of marketed drugs. For many years, the FDA has run a voluntary adverse-events reporting system (AERS) that allows health-care providers and patients to describe possible side effects.

While AERS may generate clues to new side effects, the reports are often incomplete and may raise more questions than they answer. Is the rare effect really caused by the drug? What happens if a few people report something common, like an ulcer or a heart attack? How many people would have to report something before the FDA should get interested?

More reports often help

What is clear is that some of the 400,000 AERS reports submitted each year may represent real side effects, and others do not. One argument says that until further studies understand whether a drug actually causes a side effect, making a suspicion public would be counter-productive; for example, patients benefiting from the drug might stop needlessly.

I see a potential benefit to publicizing AERS reports that the FDA is investigating. Suggesting tenuous relationships between drugs and unusual side effects may prompt other physicians or consumers to recognize that they, too, may have seen (or been) similar cases. More reports do not establish cause and effect, but have helped in the past.

I also see an opportunity for coupling this kind of reporting to increasing public awareness of the risks vs. the benefits of treatment with any drug. An aware public will understand that because the FDA is investigating a potential relationship does not establish that a relationship even exists.

There is no drug that is 100 percent effective and never causes side effects. What we don’t want are drugs where the risks are much greater than the potential benefits, or where we can’t pick out the people at high risk for serious side effects. The new reporting system may, therefore, be one small step toward identifying unsafe drugs.

©2012 An Inconvenient Woman. All Rights Reserved.

Gardasil® Deaths, Gardasil® Side Effects, Gardasil® Paralysis -

Is the HPV Vaccine Given to Prevent Cervical Cancer Causing More Medical Problems?

A vaccine designed to prevent cervical cancer is coming under fresh scrutiny amid thousands of complaints linking it to a range of health problems.

Gardasil® has been the subject of 7,802 “adverse event” reports from the time the Food and Drug Administration approved its use two years ago, according to the Centers for Disease Control and Prevention.

Girls and women have blamed the vaccine for causing ailments from nausea to paralysis — even death. Fifteen deaths were reported to the FDA, and 10 were confirmed, but the CDC says none of the 10 were linked to the vaccine. The CDC says it continues to study the reports of illness.

Gardasil prevents the spread of human papillomavirus, known as HPV — a sexually transmitted virus that can cause cervical cancer in a relatively small number of girls and women.

The vaccine’s manufacturer, Merck & Co. Inc., says it has distributed more than 26 million Gardasil® vaccines worldwide, including nearly 16 million in the United States. It estimates that 8 million girls and women have received the vaccine in the United States since June 2006. V

Two girls allege in court that the vaccine made them sick.

One — Jesalee Parsons of Broken Bow, Oklahoma — got the shot at age 13.

Jesalee’s lawyer, Michael McLaren, said she got the shot on February 27, 2007 and soon developed a fever and felt pain. The next day, he said, Jesalee felt pain in her chest and abdomen.

Her mother, Laura Parsons, said Jesalee spent weeks in the hospital and underwent two surgeries after developing pancreatitis. She says the federal government should have studied the drug more before approving its use.

“I just feel let down by the government,” Parsons said.

Merck says it could be a coincidence that the girls got sick after receiving the vaccine.

The company said in a statement that an adverse event report “does not mean that a causal relationship between an event and vaccination has been established — just that the event occurred after vaccination.”

Merck said it would continue to evaluate reports of adverse reactions. It said it “updates product labels with new safety information as appropriate.”

Watch more on complications linked to Gardasil »

For Full Article and more video go to:

http://www.cnn.com/2008/HEALTH/conditions/07/07/cervical.cancer.vaccine/

A sincere thank you to major media outlets, CNN, the Washington Post and the New York Times, for following and reporting the Gardasil® adverse events and asking probing questions about the safety and effectiveness of this aggressively-marketed Merck product.

©2012 An Inconvenient Woman. All Rights Reserved.

On this page:

• Genetic Engineering
• Benefits of GE Animals
• GE Animals Regulated Under New Animal Drug Provisions

The Food and Drug Administration (FDA) is inviting the public to comment on draft guidance that discusses FDA’s approach to regulating genetically engineered (GE) animals.

Although the guidance, released Sept. 18, 2008, is aimed at industry, FDA believes it may also help the public gain a better understanding of this important and developing area. The guidance explains the process by which FDA is regulating GE animals.

Genetic Engineering

Genetic engineering is a process in which scientists use recombinant DNA (rDNA) technology to introduce desirable traits into an organism. DNA is the chemical inside the nucleus of a cell that carries the genetic instructions for making living organisms. Scientists use rDNA techniques to manipulate DNA molecules.

Genetic engineering involves producing and introducing a piece of DNA (the rDNA construct) into an organism so new or changed traits can be given to that organism. The rDNA construct can either come from another existing organism, or be synthesized in a laboratory. Although conventional breeding methods have been used for a long time to select for desirable traits in animals, genetic engineering is a much more targeted and powerful method of actually introducing specific desirable traits into animals.

Genetic engineering is not a new technology. It has been widely used in agriculture, for example, to make crops like corn and soy resistant to pests or tolerant to herbicides. In medicine, genetic engineering is used to develop microbes that can produce pharmaceuticals. And in food, genetic engineering is used to produce enzymes that aid in baking, brewing, and cheese making.

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Benefits of GE Animals

GE animals hold great promise for human and animal health, the environment, and agriculture.

• Health protection of animals – Animals are under development to be more resistant to very painful and harmful diseases, such as infection of the udder (mastitis) in dairy cows and bovine spongiform encephalopathy (widely referred to as “mad cow” disease) in all cattle.
• New source of medicines – Animals can be engineered to produce particular substances, such as human antibodies, to make infection-fighting drugs for people. These “biopharm” animals can change the way we treat chronic diseases, such as bleeding disorders, by providing large quantities of safe, health-restoring proteins that previously were available only from human cadavers.
• Transplantation – Pigs are being engineered so that their cells, tissues, or organs could be transplanted into humans with a reduced risk of immune rejection.
• Less environmental impact – Food animals are being engineered to grow more quickly, require less feed, or leave behind less environmentally damaging waste.
• Healthier food – Food animals, such as pigs, are under development to contain increased levels of omega-3 fatty acids, providing a more healthful product. Livestock can also be engineered to provide leaner meat or more milk.

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GE Animals Regulated Under New Animal Drug Provisions

FDA regulates GE animals under the new animal drug provisions of the law, and the agency must approve them before they are allowed on the market. Food and animal feed from GE animals will undergo FDA review before the food or feed can be marketed. The Federal Food, Drug, and Cosmetic Act defines a drug as “an article (other than food) intended to affect the structure or any function of the body of man or other animals.” Therefore, the rDNA construct intended to change the structure or function of the body of the GE animal is a drug.

FDA may exercise “enforcement discretion” over some GE animals, based on their potential risk and on a case-by-case basis. This means that the agency may not require premarket approval for a low-risk animal. For example, the agency is not requiring premarket approval for GE lab animals used for research, and did not require approval of a GE aquarium fish that glows in the dark. FDA does not expect to exercise enforcement discretion for animal species traditionally consumed as food.

This guidance will help industry comply with FDA’s requirements and will help the public understand FDA’s oversight of GE animals and food from such animals.

This article appears on FDA’s Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.

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For More Information

FDA welcomes comments on its 25-page draft guidance document at www.fda.gov/dockets/ecomments or www.regulations.gov. Once on this Internet site, select Docket No. FDA-2008-D-0394 and follow the directions. All written comments should be identified with Docket No. FDA-2008-D-0394. The comment period runs for 60 days and closes Nov. 18, 2008.

FDA has developed a number of publications to help inform consumers about the technology of GE animals and the agency’s regulation of these animals. Please visit www.fda.gov/cvm/GEAnimals.htm.

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Date Posted: September 18, 2008Science

©2012 An Inconvenient Woman. All Rights Reserved.

FDA Approves Expanded Uses for Gardasil® to Include Preventing Certain Vulvar and Vaginal Cancers

The U.S. Food and Drug Administration today announced the approval of the vaccine Gardasil for the prevention of vaginal and vulvar cancer caused by Human Papillomavirus (HPV) types 16 and 18 in girls and women ages 9 to 26. These two HPV types cause 70 percent of cervical cancers, and are known to also cause some vulvar and vaginal cancers, but the percentages are not well defined.

“There is now strong evidence showing that this vaccine can help prevent vulvar and vaginal cancers due to the same viruses for which it also helps protect against cervical cancer,” said Jesse L. Goodman, M.D., M.P.H., director of the FDA’s Center for Biologics Evaluation and Research. “While vulvar and vaginal cancers are rare, the opportunity to help prevent them is potentially an important additional benefit from immunization against HPV.”

The FDA originally approved Gardasil in 2006 for girls and women ages 9 to 26 for the prevention of cervical cancer caused by HPV types 16 and 18, precancerous genital lesions caused by HPV types 6, 11, 16, and 18 and genital warts caused by HPV types 6 and 11.

HPV includes more than 100 related viruses and more than 30 types can be transmitted via sexual contact. According to the U.S. Centers for Disease Control and Prevention, HPV is the most common sexually transmitted infection in the United States with 6.2 million Americans becoming infected with genital HPV each year.

For most women, the body’s own defense system will clear HPV, thereby preventing serious health problems. However, some HPV types can cause abnormal cell growth in areas of the cervix, vagina, vulva, and other areas that years later may turn into cancer.

Regarding the prevention of vulvar and vaginal cancer, Gardasil’s manufacturer, Merck & Co. Inc., followed more than 15,000 participants from the original studies for about two additional years. Approximately half had received Gardasil as part of the original study—the other half did not receive Gardasil and served as a control group.

Among females who tested negative for HPV types 16 or 18 at the start of the study, Gardasil was highly effective in preventing these types of HPV-related precancerous vulvar and vaginal lesions, which are considered to be the precursors for cancer. In the control group that did not receive the vaccine, 10 individuals developed precancerous vulvar lesions and nine developed precancerous vaginal lesions, all related to HPV types 16 or 18. No one in the Gardasil group developed either kind of precancerous lesion due to HPV types 16 or 18.

There was no evidence for benefit among women found to have been previously infected, prior to immunization, with the HPV types included in the vaccine. Therefore, to receive Gardasil’s full potential for benefit, it is important to be vaccinated prior to becoming infected with the HPV strains contained in the vaccine.

Gardasil’s label has been revised to note that presently available information is insufficient to support use beyond age 26, the current FDA-approved age. Also, new information has been added showing that Gardasil does not protect against diseases caused by HPV types not contained in the vaccine.

No vaccine is 100 percent effective, and Gardasil does not protect against HPV infections that a woman may already have at the time of vaccination. Therefore, all women should get regular Pap tests, even after they have been vaccinated. Routine Pap screening remains critically important to detect precancerous changes, which would allow treatment before cancer develops.

Since the FDA approved Gardasil in 2006, the majority of reported adverse events have not been serious. The most commonly reported adverse events have included syncope (fainting), pain at the injection site, headache, nausea, and fever. Fainting is common after injections and vaccinations, especially in adolescents. Falls after fainting may sometimes cause serious injuries, such as head injuries, which can be prevented with simple steps, such as keeping the vaccinated person seated for up to 15 minutes after vaccination. This observation period is also recommended to watch for severe allergic reactions, which can occur after any immunization.

As part of the original approval, Merck committed to a safety surveillance study of 44,000 individuals in a managed care organization. The study is assessing short- and long-term safety for all of Gardasil’s approved uses.

As with all vaccines, the FDA and the CDC continue to closely monitor Gardasil’s safety. Updated safety information on Gardasil was published on July 22 and can be found at www.fda.gov/cber/safety/gardasil071408.htm.

Product approval information for Gardasil can be found at www.fda.gov/cber/products/gardasil.htm.

Merck & Co. Inc. is located in Whitehouse Station, N.J.

Me

©2012 An Inconvenient Woman. All Rights Reserved.