HPV, human papillomavirus, is an infection that is passed from one person to another through direct skin-to-skin contact. When genital skin (on the penis, scrotum, vulva [area near the opening to the vagina] and near the anus [rectal opening]) is involved, the infection is called “sexually-transmitted”.

There are about 100 different types of HPV. Most HPV infections do not cause any health effects at all because the infected person’s immune system gets rid of them before they can do any damage. At times certain types of HPV (“low risk”) can cause minor changes. Usually those types do not cause long term problems. But other types (“high risk”) can cause infected cells to lose control of their own growth; if early changes are not found and treated, these changes can turn into cancer years later.

Why is this important for women’s health?

HPV infection is very common. One of the sites most often infected by HPV is the genital tract. Several studies have shown that young sexually active women become infected with HPV in the genital area at the rate of 15-20% per year. When followed for three years, about 80% of women in those studies tested positive for HPV at one time or another.

When certain “low risk” types of HPV infect the outer genital skin (vulva) or cervix, they can cause genital warts (also known as condylomata acuminata) and harmless changes on the cervix. Other “high risk” types commonly infect the cervix where they can cause changes that might become cancer in the future ( dysplasia), depending on the type of HPV and the length of time the infection has lasted. If high-risk HPV infections on the cervix are not found and not treated for years, some of those infections can result in cervical cancer.  Over 4000 women die each year in the US from cervical cancer.

How is HPV infection spread?

Vaginal, oral and anal sex can all spread HPV. Many persons who have HPV do not know they have it – they can spread it to their sexual partners without knowing it. Most people who become infected with HPV have gotten it from a partner who had no symptoms at all.

How would I know if I had HPV?

Often infected women and men do not know that that they have an HPV infection. Some persons develop genital warts or condylomata acuminata which are small, raised, skin-colored or gray rough-surfaced bumps ranging from the size of sesame seeds to the size of apple seeds or even larger. They usually don’t hurt, but they may itch slightly or feel irritated. Your clinician can identify these lesions during an exam. Other persons develop HPV infections of the cervix (the lower part of the uterus, located at the top of the vagina). These infections do not produce symptoms that patients can see or feel. The only way to know about an HPV infection of the cervix is to have a Pap test or cervical HPV test performed during a pelvic exam. A Pap showing dysplasia or intraepithelial neoplasia or cervical cancer almost always is a result of
HPV infection.

What is a Pap test?

In this test, cells are scraped off the cervix and placed on a slide. A specially trained laboratory professional examines the slide and looks for abnormal cells. If abnormal cells are found, the slide is further reviewed by a pathologist. The Pap test report gives useful and important information to the clinician, helping him or her decide whether further testing is necessary if the results are abnormal.

What is an HPV test?

The HPV test is performed either from the same specimen as a Pap test, or from a separate brush sample from the cervix. It detects HPV genetic material (DNA) from the 13 types of HPV that can most commonly be associated with the development of cervical cancer. These are the “high risk” types. Most people who are infected with these types of HPV may never have any related problems. However, women who have a high-risk type of HPV are much more likely than uninfected women to develop a cervical pre-cancer (dysplasia) or cancer over time.

Which test should I get: an HPV test or a Pap test?

The most important test for every sexually-active woman to have regularly is the Pap test. If her Pap is abnormal, further testing can be done to determine the exact location and nature of the abnormality and to treat it. Early detection and treatment are highly successful at preventing cervical cancer.

Then who should get an HPV test?

The HPV test is helpful in women whose Pap test report is “ atypical squamous cells of undetermined significance”, often abbreviated as “ASC-US”. This means that the result is uncertain – it is not normal but it is also not abnormal in any precisely defined way. Some of these Pap tests with uncertain results show HPV infection on additional testing. So the HPV test can help your clinician understand the reason for the uncertain Pap. In addition, most experts believe that for women over 30, HPV testing along with a routine Pap test is the best way to screen for dysplasia or cervical cancer. This combination of testing is so reliable that if both tests are normal, the tests should be repeated only every three years.

In addition, an HPV test may be recommended as part of follow-up after an abnormal Pap test has been evaluated and possibly treated.

Why not test women under 30 for HPV with their Pap test?

HPV is so common and so unlikely to cause problems in young women that finding it isnot helpful. On the other hand, the Pap test does find cell changes thatare important to evaluate.

What if my test is negative?

A woman whose HPV DNA test is negative has only a small chance of having dysplasia or cancer at the time of the test. But she should continue to obtain regular Pap tests to detect any hidden or future infection.

What happens if my HPV test shows that I have HPV?

If you have a positive HPV test and an abnormal Pap, you will most likely be advised to undergo colposcopy. This is a procedure in which the cervix is examined using a bright light and magnification. Often a biopsy (a small pea-sized piece of tissue) is taken and sent to a pathology lab for examination. The biopsy is the most reliable test and the results of the biopsy, not the Pap or the HPV test, are used in planning the most appropriate treatment, if any.  If you have a positive HPV test and a normal Pap test, your healthcare provider will make a personal recommendation for you based on your own individual health circumstances and your past Pap and HPV history.

Copyright © 2003, 2008 ASCCP. All Rights Reserved.
These materials were developed by the American Society for Colposcopy and Cervical Pathology (ASCCP) Patient Education Committees and approved by the Board of Directors for use by patients.

While you may download, print and distribute these materials freely, they are copyrighted materials and all rights are owned by ASCCP. Therefore, they may not be changed, edited or altered in any way.

©2012 An Inconvenient Woman. All Rights Reserved.

HPV is human papillomavirus. It is the most common viral sexually transmitted infection for both men and women. Some types of HPV are called “low risk”.

Those can infect the skin around the genitals and cause genital warts. Other types of HPV are called “high risk”. When those types infect internal genital areas they sometimes cause precancerous or cancerous changes on the cervix (opening to the uterus) or vagina. “High risk” HPV can also cause precancerous changes on the external genital areas (vulva).

How common is HPV?

HPV is very common. Most men and women who have had sex get HPV. Fortunately, many HPV infections go away on their own without causing any problems for theinfected person. Most infected people don’t even know they have had HPV.

Is HPV infection serious?

There are lots of different kinds of HPV, and most are not serious. Infection with a “low risk” virus can cause genital warts but will not produce major problems. However, sometimes “high risk” HPV infection can cause skin cells to grow abnormally. The growth may be precancerous and could eventually become a potentially serious problem, such as cancer of the cervix, vagina, vulva, or anus.

How did I get HPV?

You probably got HPV through skin-to-skin contact with an infected person during vaginal, oral, or anal sex. It is possible for a person to have HPV in skin cells and pass it on to another person even when no genital warts are present. Most people who have HPV do not have any signs of it and do not know they have it.

What about HPV and oral sex?

If a person performs oral sex on a partner with genital HPV, there is a small chance that his or her mouth can become infected. Wart-like lesions and precancers can develop in the mouth or throat. Untreated precancerous lesions in the mouth or throat can turn into cancer after a long time. If a person receives oral sex from a partner with HPV in his or her mouth, that person can possibly develop a genital HPV infection. Currently there is no screening test for oral HPV. Your healthcare provider or dentist can carefully examine your mouth to look for lesions, but it is unknown how helpful that will be in preventing HPV-related mouth or throat cancers.

What increases my chances of developing a genital HPV infection?

The more sexual partners you have, the greater your chances are of getting an HPV infection. Using condoms may reduce your chances of getting infected, but condoms do not always help because HPV can be present in areas not covered by the condom. Your immune system also determines whether you may develop a HPV infection when you are exposed. A healthy immune system keeps you from being sick. People with poorly functioning immune systems are more likely to get a HPV infection. Smoking tobacco weakens your immune system and increases your risk for getting HPV when exposed to the virus.

How long have I had HPV?

It is impossible to know exactly how long you have had HPV. If you have had more than one sexual partner in your lifetime, it is impossible to tell which partner gave you HPV. If you had sexual contact with an infected person, it usually takes a few weeks or months for genital warts to appear or for a Pap test to become abnormal. You may have had HPV for some time before it was discovered by a physical exam, abnormal Pap test, or HPV laboratory test.

How is HPV diagnosed?

HPV can be diagnosed in several ways.

• Sometimes the skin changes on external areas can be seen on physical exam.
• Many infected women first learn they have HPV when they have an abnormal Pap test.
• At times, a specific test for the HPV virus recognizes it in infected cells on the cervix. (This test is not useful on other parts of the body or in men.
• When HPV infection of the cervix or vagina or anus is suspected, your health care provider can use a colposcope to shine a light on and magnify the cervix and vaginal walls and/or the anus. Often a tiny piece of tissue (a biopsy) is taken and examined in a laboratory to check for changes produced by HPV

How is HPV treated?

Like all other virus infections, HPV infection cannot be cured with medication. Luckily, your body’s immune system can and usually does get rid of the infection and the skin changes it causes.

However, the abnormal skin growths (genital warts or precancerous changes) caused by HPV can be treated with medication or minor surgery. The type of treatment depends on the location, number, and kind of skin changes. If the virus has caused only slight abnormalities, then no treatment may be necessary at this time. Careful monitoring for future changes with self-examination, regular Pap tests, or possible colposcopy may be necessary. If more severe skin abnormalities are found, they often need to be treated.

There are many ways that your health care provider can treat abnormal areas. Some treatment can be done at home, and other types of treatment must be done in the clinic. Your health care provider will discuss these treatment options with you.

Will I still have HPV after treatment?

There is no cure for HPV. The goal of treatment is to remove the abnormal area that contains the virus without causing damage to the normal, healthy tissue surrounding the abnormal area. It is likely that a small amount of virus will remain after treatment. Often your body’s immune system can take care of the remaining virus.

How can I prevent spreading HPV to others?

You can reduce the chance that you will share your HPV infection with other people by having any abnormal skin or genital warts treated until they are gone. Using condoms during sexual intercourse and dental dams during oral sex may also help to reduce the spread of infection. However, condoms or dams may not always completely prevent the spread of HPV infection, because HPV may be in skin that is not protected by the condom or dam. Now that you know you have HPV, you should tell your current (and past) sexual partner(s), so that they can be examined and treated, if appropriate.

Will having HPV cause problems if I become pregnant?

Problems caused by HPV in pregnancy are unlikely. There is a very small chance that your baby could catch HPV from you. The baby could inhale HPV-infected cells from your birth canal during birth. Although it rarely happens, the baby’s vocal cords can become infected with the virus. This could cause breathing problems and would require treatment. Usually, women with HPV have regular vaginal deliveries. Only women who have very large genital warts that block the birth canal need a Cesarean section because of the HPV infection.

What should I do to take care of myself?

• You may want to check yourself for the development of new warts following treatment.
• If you discover new genital warts, have them treated as soon as possible.
• Having genital warts may mean that you are at a slightly greater risk for getting
• cervical cancer.
• Women should have regular Pap tests.
• If you smoke tobacco, stop!
• Try to keep your stress level low, get enough sleep, and eat a nutritionally
• balanced diet.
• If you are a woman between the ages of 9 and 26, ask your healthcare provider whether you should get the HPV vaccine. Even if you have already been infected with one type of HPV, the vaccine will prevent infection with other types.

How can I cope with HPV?

Be sure to get regular check-ups, including Pap tests. If you see genital skin changes, make an appointment with your health care provider for an exam. These feelings are normal. It is common for people with HPV to feel angry, upset, depressed or ashamed about their condition. Some women may also be concerned about the risk for cancer. Keep in mind that HPV can be managed and cervical cancer can almost always be prevented. Talk to your health care provider about your concerns. Keeping yourself healthy and not smoking can help boost you body’s natural defense system to fight the virus.

Copyright © 2003, 2008 ASCCP. All Rights Reserved.
These materials were developed by the American Society for Colposcopy and Cervical Pathology (ASCCP) Patient Education Committees and approved by the Board of Directors for use by patients.

While you may download, print and distribute these materials freely, they are copyrighted materials and all rights are owned by ASCCP. Therefore, they may not be changed, edited or altered in any way.

©2012 An Inconvenient Woman. All Rights Reserved.

Merck (MRK) is expected to report Q2 earnings Tuesday, July 21, before market open, with a conference call scheduled for 8:30 am ET.

Guidance

Analysts are looking for EPS of 77c on revenue of $5.84B. The consensus range is 75c-79c for EPS, and $5.70B-$5.98B for revenue, according to First Call. On April 21, Merck reaffirmed its FY09 EPS guidance of $3.15-$3.30 versus a consensus of $3.25.

Analyst Views

Possible positive drivers for Merck this quarter might be seen in its Singulair and Januvia sales. Weighing on this quarters earnings will be the loss of patent protection on Fosamex and slower Gardasil sales. Sales of cholesterol drugs Vytorin and Zetia, co-marketed by Schering-Plough (SGP), might also be disappointing especially in a weak economy with cheaper alternatives.

In late June, UBS mentioned Merck cautiously, citing May as another weak month for Merck’s U.S. vaccines franchise.

On July 9, Natixis downgraded Merck to Hold from Buy.

©2012 An Inconvenient Woman. All Rights Reserved.

Why is This a Model America Wishes To Emulate?

You should never trust Big Pharma to protect your interest. They are for profit organizations, to make money. Unfortunately, some have gone overboard and sold their souls to mammon.

— Matthew Day, Telegraph, Reporter

The medical staff, including three Polish doctors and six nurses from the northern town of Grudziadz, are being investigated over medical trials in which homeless and poor people who died last year. Prosecutors say the medical trial involved an untried vaccine to the highly-contagious H5N1 bird-flu virus.

Authorities claim that the alleged victims received £1-2 to be tested with what they thought was a conventional flu vaccine but, according to investigators, was actually an anti bird-flu drug.

The director of a Grudziadz homeless centre, Mieczyslaw Waclawski, told a Polish newspaper that last year, 21 people from his centre alone, died, a figure well above the average annual flu deaths of about eight.

Although authorities have yet to prove a direct link between the deaths and the activities of the medical staff, Poland’s health minister, Ewa Kopacz, has said that the doctors and nurses involved should not return to their profession.

“It is in the interests of all doctors that those who are responsible for this are punished,” the minister added. Investigators are also probing the possibility that the medical staff may have also have deceived the pharmaceutical companies that commissioned the trials.

The suspects said that the all those involved knew that the trial involved an anti-H5N1 drug and willingly participated.

The news of the investigation will come as another blow to the reputation of Poland’s beleaguered and poverty-stricken national health service. In 2002, a number of ambulance medics were found guilty of killing their patients for commissions from funeral companies.

©2012 An Inconvenient Woman. All Rights Reserved.

The Environmental Protection Agency is poised to rule that it will not set a drinking-water safety standard for perchlorate. This component of rocket fuel has been linked to thyroid problems in pregnant women, newborns and young children across the nation.

The story broke last week in a number of major newspapers; but was pushed to the back pages by the looming “debt-bomb” about to dropped on the taxpayers in the name of friendly fire from our elected representatives. No one in good conscious could refer to anyone in Washington, of any political stripe, as “leaders”, but that is another story for another day.

The EPA’s “preliminary regulatory determination” estimates that up to 16.6 million Americans are exposed to perchlorate at a level many scientists consider unsafe. Independent researchers, using federal and state data, have put the number at 20 million to 40 million.

Most perchlorate contamination in U.S. drinking water is the result of improper disposal by rocket test sites, military bases and chemical plants. A nationwide cleanup could cost hundreds of millions, if not billions, of dollars, and several defense contractors have threatened to sue the Defense Department to help pay for it if one is required. The Government Accountability Office reported this spring that the Pentagon had pressured the EPA for several years not to regulate perchlorate.

“They have distorted the science to such an extent that they can justify not regulating” the chemical, said Robert Zoeller, a University of Massachusetts professor who specializes in thyroid hormone and brain development and has a copy of the EPA proposal. “Infants and children will continue to be damaged, and that damage is significant.”

Zoeller said scientific studies have shown that a small reduction in thyroid function in infants can translate into a loss of IQ and an increase in behavioral and perception problems. “It’s absolutely irreversible,” he said. “Even small changes in thyroid functions early on have impacts on functioning through high school and even into people’s 20s.”

According to a Washington Post article, OMB officials deleted any references to those studies in the EPA’s proposal.

The current EPA document states that establishing a drinking-water standard for perchlorate “would not present a ‘meaningful opportunity for health risk reduction for persons served by public water systems,’ ” but it also reveals that many Americans will be exposed to the compound at levels higher than recommended if nothing is done to remove it. Perchlorate impedes the functioning of the thyroid gland, which produces hormones that foster mental and physical development and control metabolism. The notice indicates that the agency plans to finalize its decision by December 1st, 2008.

In response to the “dust-up” over the preliminary report, the EPA’s assistant administrator for water, Benjamin H. Grumbles, stated; “Science, not the politics of fear in an election year, will drive our final decision.”

“Until then, final numbers and strategies are mere speculation,” Grumbles added. “We know perchlorate in drinking water presents some degree of risk and we’re committed to working with states and scientists to ensure public health is protected and meaningful opportunities for reducing risk are fully considered.”

In January 2002, the EPA issued a draft risk assessment finding that 1 part per billion should be considered safe; in March 2006, the Massachusetts Department of Environmental Protection set a maximum contaminant level of 2 ppb; last year, California adopted a standard of 6 ppb.

A National Academy of Sciences panel prepared a risk analysis in 2005 that, according to the EPA’s traditional models, would produce a protective standard of 1 to 6 ppb. The academy’s study came under attack because two of the committee’s members had financial ties to defense contractors that face legal liability because of perchlorate disposal.

The EPA’s proposed ruling assumes that perchlorate contamination of 15 ppb is safe. But its regulatory document states that “between 16,000 and 28,000 pregnant women” and 900,000 to 2 million Americans could be exposed to higher levels.

The EPA document also finds that bottle-fed infants would be exposed to more than five times the level the National Academy of Sciences deemed safe — 700 nanograms per kilogram of body weight per day — if parents mix formula with drinking water containing perchlorate levels of 15 ppb.

OMB officials said during the drafting process that there was “no need” for detailed data to flesh out a table suggesting that infants would be exposed to perchlorate levels above the academy’s recommendation.

To determine safe levels of exposure, the OBM opted not to use the academy’s “reference dose,” a formula that includes a tenfold safety factor to protect children and vulnerable populations, and instead used a computer model developed by the Chemical Industry Institute of Toxicology. EPA officials initially inserted language in the document calling this a “novel approach,” but the OMB deleted that language.

Federal officials have yet to determine the extent of perchlorate contamination nationwide, but it is known to be widespread. The GAO, which produced a 2005 report calling for a better federal tracking system for perchlorate, found that limited EPA data show the chemical compound has polluted the soil, groundwater and drinking water in 35 states and the District and has contaminated 153 public water systems in 26 states.

Stay tuned, and don’t drink the water, or swallow the Kool-Aid.

©2012 An Inconvenient Woman. All Rights Reserved.

The conclusions of the study found that men with old-fashion attitudes about gender roles (traditional view) earn about $11,930 more per year than men who view women in the workplace as equals (egalitarian views).

The Washington Post reports that this study shows men are also “victims of gender-related income disparities.”

Women are usually the ones called victims of wage differences, traditionally the ones that make less money then men in comparable jobs. [The Washington Post: “Study Ties Wage Disparities To Outlook on Gender Roles ”]

The Post article adds, “The study raises the provocative possibility that a substantial part of the widely discussed gap in income between men and women who do the same work is really a gap between men with a traditional outlook and everyone else.”

Specifically, in an equalitarian (equal for men and women) workplace men earned on average $22,795, while in a traditional (not equal) workplace men earned on average $34,725—a difference of $11,930.

In an egalitarian workplace, women earned an average of $21,373, however, in a traditional workplace, women earned an average of $20,321—a difference of $1,052.

Thus, men in a traditional setting, earn $14,404 more than women earn. In addition, men in an egalitarian setting, earn $1,422 more than women do. The difference is almost ten times as great between the traditional and equalitarian settings.

Women, on the other hand, still make less money than men do in either situation.

The authors state in the abstract to their paper, “This implies that traditional men are rewarded in the workplace for seeking to preserve the social order, whereas traditional women seeking to do the same are not necessarily penalized. Indeed, women in general tend to make less than men, regardless of their gender role orientations.”

Beth A. Livingston, one of the two authors for the study, stated, “When we think of the gender wage gap, most of our focus goes to the women side of things. This article says a lot of the difference may be in men’s salaries.” [The Washington Post]

Livingston added, “We actually thought maybe men with traditional attitudes work in more complex jobs that pay more or select higher-paying occupations. Regardless of the jobs people chose, or how long they worked at them, there was still a significant effect of gender role attitudes on income.” [The Washington Post]

Dr. Timothy A. Judge, the other author of the study, stated, “Some would say, ‘Of course traditional men earn more than traditional women — they are both fulfilling their desires to play different roles in the home and workplace.’ Our results do not support that view. If you were a traditional-minded woman, would you say, ‘I am fine working the same hours as a traditional-minded man in the same industry with the same education but earning substantially less’? I don’t think traditional-minded women would say that.” [The Washington Post]

The study was published in the Journal of Applied Psychology under the title “Is the Gap More Than Gender? A Longitudinal Analysis of Gender, Gender Role Orientation, and Earnings.” [A pdf file, the entire article is available for reading.]

Its authors are American organizational psychologists Timothy A. Judge (a professor from the Warrington College of Business Administration, Department of Management) and Beth A. Livingston (a doctorial student in Organizational Behavior and Human Resource Management), both from the University of Florida, Gainesville.

The authors used data collected by the U.S. government between 1979 and 2004 using the U.S. Labor Department’s National Longitudinal Survey of Youth.

The survey began collecting data on 12,000 people in the United States between the ages of 14 and 22 years, and continued to collect information over the next 25 years.

The abstract to their paper states, “This study investigated the relationships among gender, gender role orientation (i.e., attitudes toward the gendered separation of roles at work and at home), and earnings. A multilevel model was conceptualized in which gender role orientation and earnings were within-individual variables that fluctuate over time (although predictors of between-individual differences in gender role orientation were also considered).”

Specifically, the researchers classified men and women as traditionalists when they believed men and women had distinct (traditional) roles in society, both at home and in the workplace, such as men should work outside of the home and women stay home.

People were classified as egalitarianists if they believed men and women should have equal roles at home and in the workplace, such as both women and men should be able to work outside the home.

They concluded about the data they analyzed, “Results indicated that whereas traditional gender role orientation was positively related to earnings, gender significantly predicted the slope of this relationship: Traditional gender role orientation was strongly positively associated with earnings for men; it was slightly negatively associated with earnings for women. Occupational segregation partly explained these gender differences.”

And, “Overall, the results suggest that although gender role attitudes are becoming less traditional for men and for women, traditional gender role orientation continues to exacerbate the gender wage gap.”

The study does not try to explain the reasons why these wage disparities (gaps) occur, only that they still do occur in American society.

However, both authors do offer two possible possibilities for the wage disparities. They state that traditional men may negotiate their salaries better with their bosses than the other three groups of people (egalitarian men, egalitarian women, and traditional women).

They also state that U.S. employers may still discriminate against men and women with egalitarian viewpoints.

This article was originally posted by William Atkins in ITWIRE on Tuesday, 23 September 2008

©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.

back to top

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.

back to top

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.

back to top

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.

back to top

Date Posted: September 18, 2008Science

©2012 An Inconvenient Woman. All Rights Reserved.

Merck has a growing economic interest in Virginia. In December 2006, Merck announced it would invest $57 million to expand its Elkton, Va., plant to make Gardasil, helped by a $700,000 grant from a state economic development agency that is part of the executive branch. Two months later, Gov. Tim Kaine, who has been mentioned as a possible Democratic vice presidential candidate, signed legislation requiring Gardasil for schoolgirls. Four months after that, Merck pledged to invest $193 million more in the plant to make drugs and vaccines, helped by a state grant of $1.5 million.

Source: New York Times

©2012 An Inconvenient Woman. All Rights Reserved.

“Merck lobbied every opinion leader, women’s group, medical society, politicians, and went directly to the people — it created a sense of panic that says you have to have this vaccine now.”

— Dr. Diane Harper, a professor of medicine at Dartmouth Medical School

Those who follow BIG PHARM have noticed some interesting trend-lines lurking in the infamous ‘9-point Helvetica, grey ink’ Corporate 10-K, Annual Reports. Over the past several years, research budgets trended downward, while “Marketing” expenditures accelerated.

What would be considered a BIG PHARMA marketing expense?

Marketing expenses would include clever print and electronic media ads, along with brochures for health professionals. This print material is usually given to Doctors at “Sponsored” events, “Educational” resort-based retreats, private dinners, and that basic and most appreciated pharmaceutical freebee, the “Free Lunch”! On any given day an army of pharmaceutical reps drop off Lunches and other “Goodie packages” to busy practices with free drug samples and good cheer.

Speaking of “good cheer” Marketing expenses also include BIG PHARMA lobbyists spending largest amongst the very representatives “we the people” sent to our local, state, and federal to look after our interest. The amount of cash laid down by MERCK in 2005-2006 to grease the skids for one of the fastest new drug roll outs yet witnessed is staggering. Whoever said you couldn’t buy happiness, hasn’t talked to a MERCK stockholder.

Go to: THE EVIDENCE GAP; Drug Makers’ Push Leads to Cancer Vaccines’ Rise

August 20, 2008 – By ELISABETH ROSENTHAL (NYT) – Front Page –

… DRUG MAKERS’ BIG PUSH A marketing campaign in the United States and Europe by Merck has made Gardasil, its cervical cancer vaccine, a best seller. Cervarix, a similar vaccine from GlaxoSmithKline, has also proved popular, and profitable.

Read the full article and send the link out to anyone who cares about the health issues of women and girls!

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

The lobbyist/legislator ‘hook-up’ only works if no one is looking. Make sure your representatives know you are watching them and are holding them accountable for the health and wellfare of the nations’ women and girls.

©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.