FiercePharma is reporting that the Obama administration wants to hike the FDA’s budget by 19 percent to $3.2 billion for fiscal 2010. That’s a whopping increase: In dollar terms, it amounts to about half a billion, Reuters reports. A good billion or so of the total comes from industry via user fees.

More than half of that amount would go to the “F” in FDA, however, as the administration seeks to follow through on promises to better regulate the food supply. And part of the “D”-in-FDA increase would come from levying additional fees on generic drugmakers, about $36 million worth. But given that the fees would help break the approvals logjam in FDA’s generics office, the drugmakers aren’t balking.

Will those many millions be enough? William Hubbard, a former FDA associate commissioner, told the Wall Street Journal that the boost–coupled with an emergency funding increase of $172 million last year–will help the FDA “begin to solve some problems.” That’s partly because the budget will allow hiring of more inspectors and scientists, both of which are sorely needed at the FDA, observers say.

Still, those numbers only allow enough hiring to take FDA back up to the same level as 1994, WSJ notes, the year before FDA’s budget started lagging. As you know, the Agency has watched its funding shrink repeatedly since the mid-1990s, so there’s a lot of ground to make up.

- read the Reuters news
- see the article in the Wall Street Journal

©2012 An Inconvenient Woman. All Rights Reserved.

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.

Merck’s continued looting of state and federal public health budgets for a dangerous and unnecessary vaccine is unsustainable and has to stop.

There are better, safer, more sustainable ways to prevent and treat cervical cancer both at home and in developing countries.  Safety, and ethical issues aside, as a country, we simply cannot afford the Merck solution. There are too many other critical demands for public and private health dollars.

In early 2006, when I first started writing about Gardasil, I questioned the necessity of a very expensive, possibility unsafe vaccine for a disease that was easily detected through the use of regular PAP screens and was the most treatable and curable of all cancers. According to the American Cancer Society, fewer than 4,000 lives are lost annually to cervical cancer in America. These women, precious mothers, sisters, daughters, all, could have been saved with affordable access to PAP tests. The logical answer to me was finding a way to get low income and new immigrant populations into neighborhood clinics… problem solved, women and girls did not need Gardasil.

The “500,000-Cervical Cancer Deaths” Merck touted in their marketing blitzkrieg as their HPV vaccine’s justification, referred to women in developing countries who died due to inadequate access to existing medical solutions.

Convinced that Merck’s HPV vaccine, the $400 per series  Gardasil, was simply not appropriate technology for the existing threat, I also reported on the Alliance for Cervical Cancer Prevention (ACCP) work with ‘Visual Inspection with Acetic Acid (VIA) as a low cost, easily deployable, alternative to the PAP Smear.

For middle-aged women in the developing world, cervical cancer is one of the leading causes of death. Cervical cancer is almost completely preventable, if precancerous lesions are identified and treated in a timely manner. Cervical cancer screening based on cytological examination is largely unavailable in developing countries or, made available to a small, select group of women in private facilities, maternal child health sites, or family-planning clinics, missing the age groups at highest risk for precancerous lesions.

Visual inspection with acetic acid (VIA) can be used to screen women. It can be done by nurses or midwives with appropriate training. Research results show that VIA is simple, accurate, cost-effective, and acceptable to most women. Visual inspection with acetic acid (VIA) can be done with the naked eye (also called cervicoscopy or direct visual inspection [DVI]), or with low magnification (also called gynoscopy, aided VI, or VIAM).  VILI, another variation of the visual inspection, known as Schiller’s test, uses Lugol’s iodine.

Various world health organizations and charities have been actively deploying VIA solutions in Latin America, Africa and India since the late 1990’s. By 2002 and 2003 promising results had been reported. For a very, low cost, (under $20) cervical cancer was being detected and treated successfully. When the BIG FOOT of Merck can crashing down, it lobbied for funds previously committed to more sustainable technologies.

Could the millions Merck wheedled from the Bill and Melissa Gates Foundation for doses of over-priced, possibly unsafe, vaccines be more effectively allocated? In my opinion — Yes!

As healthcare dollars become scarcer, all of us are going to ask, “What is sustainable? What solution will help the greatest number of people, affordably? What is the least invasive solution, with least opportunity for harmful side effects?”

When public health officials and medical practitioners start asking those hard questions, Merck’s HPV vaccine, Gardasil will not be the objective answer.

ACCP partner organizations in ongoing VIA research are: EngenderHealth ; International Agency for Research on Cancer (IARC);  JHPIEGO; Pan American Health Organization (PAHO);   Program for Appropriate Technology in Health (PATH)

Sources: Evaluation of visual inspection with acetic acid (VIA), Lugol’s iodine (VILI), cervical cytology and HPV testing as cervical screening tools in Latin America : this report refers to partial results from the LAMS (Latin American Screening) study
http://repositorium.sdum.uminho.pt/handle/1822/4033

Test characteristics of visual inspection with 4% acetic acid (VIA) and Lugol’s iodine (VILI) in cervical cancer screening in Kerala, India.
Sankaranarayanan R, Wesley R, Thara S, Dhakad N, Chandralekha B, Sebastian P, Chithrathara K, Parkin DM, Nair MK.

International Agency for Research on Cancer, 150 cours Albert Thomas, Lyon 69008, France. sankar@iarc.fr
http://www.ncbi.nlm.nih.gov/pubmed/12845681

Cervical cancer screening in low resource settings using visual inspection with acetic acid. Carr KC, Sellors JW. Seattle University, College of Nursing, Seattle, WA 98122, USA. Kcarr@seattleu.edu
PMID: 15236713 [PubMed – indexed for MEDLINE

©2012 An Inconvenient Woman. All Rights Reserved.

Why Do Inconvenient Women Care?

Pfizer is moving into  the vaccine, biotechnology medicines and over-the- counter product market.

Chief Executive Officer Jeffrey Kindler has been restructuring research operations at New York-based Pfizer for two years. He agreed to buy rival Wyeth, based in Madison, New Jersey, to add vaccines, biotechnology medicines and over-the- counter products. Pfizer, the world’s biggest drugmaker, needs to increase new-drug development as it braces to lose $10 billion in annual sales in 2011, when patent protection ends for its cholesterol pill Lipitor, analysts said.

For Full Story click here: Bloomberg

©2012 An Inconvenient Woman. All Rights Reserved.

Regular readers of the Inconvenient Woman Blog already know that I think the HPV vaccine, Gardasil, is a dangerous and unnecessary drug. I believe that Merck has perpetrated a clever, profitable, but deadly hoax on the public. Merck’s proven ability to buy political cover, their award winning marketing campaign and the FDA / CDC’s complete failure to protect the women and girls of this country will allow the largest transfer of public money to private stockholders in history. To the Merck shareholders HPV has come to stand for “Help Pay-For Vioxx!”

Cervical Cancer is the most treatable and survivable cancer women face. For decades regular PAP testing has given women and their physicians ample time to treat and cure the condition. In the United States less than 4,000 women annually die from cervical cancer. The HPV virus is one of the most common and transient of viruses, that in healthy adults resolves it self with out ever metastasizing into some deadly form of cancer. The women, who died, either did not have access, or chose not to avail themselves to regular preventative health care. At the current rate of Adverse Reaction Reporting, it is likely that more girls will have died from the vaccine than women of cervical cancer.

This article originally appeared in Natural News on Thursday, November 20, 2008 and was written by: Joanne Waldron, a self-titled, and citizen journalist.

What do rat poison and the HPV vaccine have in common?

The answer is a hazardous chemical known as sodium borate. Savvy readers may wonder what a toxin that is commonly used to kill rats is doing in the ingredient list for the HPV vaccine that is currently being pushed on girls as young as nine and is even being considered for men and boys. Unfortunately, the answer isn’t very comforting, especially for new U.S. residents for whom the HPV injection containing sodium borate is now mandated.

What is Sodium Borate?

Sodium borate, a boric acid salt also known as borax, has many common uses. In addition to its use as a rat poison, it is also used in laundry detergents, cosmetics, enamel glazes, flame retardants, and buffer solutions in chemistry. However, sodium borate also has antifungal properties, which means that its probable reason for being in the vaccine is to act as a preservative.

Sodium Borate Banned as Food Additive

Sodium borate is used as a food additive in some countries, but it is now outlawed in many places. For example, one Australian government recall site notes: “Product is Borax (sodium borate) which is a non permitted food additive and is harmful to health.” So, if it’s “harmful to health,” why is it being added to the HPV vaccine?

No Longer Used in Medical Preparations

The U.S. National Library of Medicine states in an article that boric acid is “no longer commonly used in medical preparations.” It’s a good thing, too, considering that the U.S. National Library of Medicine also reports that this substance used to be used to disinfect and treat wounds and that individuals “who received such treatment over and over again got sick, and some died.” In fact, the U.S. National Library of Medicine provides the number for Poison Control for people exposed to this chemical and notes that treatment for those exposed to it may include gastric lavage (stomach pumping), dialysis, and liquids by mouth or IV.

Sodium Borate Poisoning Symptoms Mimic Reactions to HPV Vaccine

Sadly, the information about sodium borate gets even scarier. Another government website article states that exposure to sodium borate can cause convulsions and other ill health effects. Interestingly enough, young girls who receive the HPV vaccine have reported similar symptoms to those that appear in cases of sodium borate poisoning. This particular government site provides the following warning regarding this chemical: “WARNING! HARMFUL IF SWALLOWED, INHALED OR ABSORBED THROUGH SKIN. CAUSES IRRITATION TO SKIN, EYES AND RESPIRATORY TRACT.” Given this information, is sodium borate really something that should be injected into humans? This is something the reader should carefully consider, along with the previously reported information, before choosing to receive the controversial HPV vaccine.
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About the author

Joanne Waldron is a computer scientist with a passion for writing and sharing health-related news and information with others. She runs the Naked Wellness: The Gentle Health Revolution forum, which is devoted to achieving radiant health, well-being, and longevity.

©2012 An Inconvenient Woman. All Rights Reserved.

Kathleen Slattery-Moschkau, filmmaker, talk radio host and  commentator, laid out Big Pharma’s marketing mission in a brilliant article, ‘Pharma: Still Chasing Skirts’, posted on March 13, 2009 to HuffingtonPost.com.

Kathleen Slattery-Moschkau spent ten years inside the pharmaceutical industry and can state one thing for sure: Big Pharma goes where the money is — and the money is with the women of our nation. Although women are certainly not the only targets of drug ads, winning the female audience is critical to the success of any given drug. Women are more proactive about their health, more likely to “talk to their doctor”, more likely to encourage their husbands to seek medical treatment, and more likely to manage the healthcare for the entire family. It is just darned good business for pharma to set their sights on the ladies. But what is good for business — explosive prescription sales of new drugs — is not necessarily good for public health.

This is a great article, pass it on to your friends.

For the full article go to: Pharma: Still Chasing Skirts

©2012 An Inconvenient Woman. All Rights Reserved.

Gardasil is the first virus-like particle (VLP) based vaccine ever approved

Researching Merck’s Gardasil HPV vaccine since 2005, I have read through mountains of data, reviewed medical trial results, FDA and CDC press releases, Adverse Reaction Reports, Merck’s Annual Stockholder’s report, and thousands of articles by both Big Phama’s Evangelists and Critics. In all this analysis I had missed a critical aspect of Garasil’s threat to our young women and girls. When I read Herb Newborg’s article in Natural News, I knew I had to share this critical information with our readers.

According Newborg’s research, National Institute of Health (NIH) documents indicate that Merck’s Gardasil and GSK`s Cervarix are the first type of vaccine, called virus-like particle (VLP) based vaccines, ever FDA approved. Anti-viral vaccines have traditionally been prepared by using attenuated, or weakened, forms of the infectious virus.

This type of vaccine involves complications in manufacturing. No long term studies, or studies on populations larger than the Gardasil clinical trial, (20,541 women for up to 5 years) have ever been conducted on VLP technology or the specific inter-species genetic mixing this technology represents.

The long term results of introducing into the human body genetically engineered, recombinant human, insect and animal DNA, along with human and animal strains of papillomavirus are unknown, untested and unproven, particularly when used as a vaccine, which effectively bypasses all of the body’s natural defenses against outside pathogens (skin, saliva, mucous, etc.)

The current deaths and maiming of young girls used as guinea pigs to test this new technology may be just the beginning. No one can predict what adverse consequences this newest inter-species gene mixing technology may cause.

Remember. MERCK is experimenting with the reproductive systems of an entire generation of young woman.

The Tragic Truth behind

the Gardasil Nightmare

Why have the pharmaceutical and biotechnology industries chosen to experiment with the first ever, large scale application of a new, unproven, genetically modified, inter-species gene mixing vaccine technology on the female youth of an entire generation?

Under the ruse of attempting to eradicate cervical cancer, Merck is actually engaged in the first large scale, real world deployment and testing of genetically modified DNA, genetically engineered proteins and genetics produced by the combining of genetic material from more than one origin or species in a vaccine.

The wide spread promotion and attempts to mandate the use of this drug in the United States is clearly not predicated on preventing deaths from cervical cancer as the drug has only been approved in the U.S. for use in girls 9-26, ages when deaths from cervical cancer happen rarely, if ever. Cervical cancer has been steadily decreasing in the U.S. since 1955.

The American Cancer Society states:

“Cervical cancer was once one of the most common causes of cancer death for American women. The cervical cancer death rate declined by 74% between 1955 and 1992. The main reason for this change is the increased use of the Pap test. This screening procedure can find changes in the cervix before cancer develops. It can also find early cervical cancer in its most curable stage. The death rate from cervical cancer continues to decline by nearly 4% a year. Cervical cancer tends to occur in midlife. Most cases are found in women younger than 50. It rarely develops in women younger than 20. Almost 20 percent of women are diagnosed with cervical cancer when they are over 65.”

According to a 2001 presentation by Elizabeth R. Unger Ph.D., M.D., then Acting Chief, Papillomavirus Section of the U.S. Centers for Disease Control and Prevention (CDCP):

• HPV infection is very prevalent in the population

• OVERALL 75% of population exposed

• Genital HPV is acquired around the time of sexual debut

• Consistent epidemiologic association of HPV with cervical cancer precursor lesions

• Plausible biologic mechanisms for HPV oncogenesis (cells becoming cancerous)

• HPV oncogenesis is a rare event with long interval between infection and cancer

• Infection alone is insufficient to cause cancer

• Additional factors required for neoplasia (abnormal proliferation of cells)

Paraphrasing, more than 75% of the population is exposed to HPV. HPV exposure typically occurs when a woman becomes sexually active. There is an association between HPV and cervical cancer. HPV causing cervical cancer is plausible, yet it alone does not cause cervical cancer. Cervical cancer is a rare event and there is a “long interval” between infection and development of cervical cancer.

Now follow closely.

Cervical cancer typically develops in mid life (around 48 years old) even though HPV exposure typically occurs at sexual debut. This new vaccine is purported to protect against a disease that occurs, if ever, 20 to 35 years after HPV infection. Yet the duration of protection from the vaccine is unknown.

According to the FDA Gardasil approval announcement:

“For most women, the body`s own defense system will clear the virus and infected women do not develop related health problems.

However, some HPV types can cause abnormal cells on the lining of the cervix that years later (emphasis added) can turn into cancer.”

The clinical trials on this vaccine only lasted 5 years.

It is chronologically impossible to have determined efficacy in preventing cervical cancer as a result of administration of this vaccine in the study population. Speculation as to whether the protection against HPV offered by this vaccine lasts beyond the five years of studies conducted to date is just that, speculation.

By the FDA`s own statement: “For most women, the body`s own defense system will clear the virus”. Combined with the frequent Pap tests of study participants who were participating in a study of sexually transmitted disease, it is fair to say that the 20,541 sixteen to twenty-six year old participants in the clinical trials were far from a random representation of the average female`s risk for contracting HPV or developing cervical cancer.

The studies on nine to fifteen year old girls included far fewer participants and were halted prior to completion.

Speculation as to whether or not girls vaccinated with Gardasil will experience a lower rate of cervical cancer 10 to 30 years from now is also merely conjecture. As such, there is currently no official schedule on required booster doses of the drug.

In the FDA`s approval announcement, they state: “While the study period was not long enough for cervical cancer to develop, the prevention of these cervical precancerous lesions is believed highly likely to result in the prevention of those cancers.”

Believed highly likely?

Is the role of the FDA to ensure that a drug has been proven to be a safe and effective or have we reduced the burden down to “likely to convey some benefit, maybe, sometime down the road”?

In addition, according to the FDA announcement of Gardasil`s approval , somehow the association and plausible mechanism between HPV and cervical cancer with the crystal clear statement that HPV “infection alone is insufficient to cause cancer” stated in the 2001 CDCP presentation magically morphed into “HPV is the cause of 70% of all cervical cancer”.

Promoting a new, unproven, vaccine to an entire generation of young girls as a cancer vaccine, without adequate long-term safety or efficacy testing is unethical and in this author`s opinion immoral.

But wait, there is much more.

This is a whole new type of vaccine called a virus-like particle (VLP) vaccine. Anti-viral vaccines have traditionally been prepared by using attenuated, or weakened, forms of the infectious virus. This type of vaccine involves complications in manufacturing.

These brand new virus-like particle (VLP) based vaccines including Merck`s Gardasil and GSK`s Cervarix are the first ever FDA approved VLP vaccines.

No long term studies or studies on populations larger than the Gardasil clinical trial (20,541 women for up to 5 years) have ever been conducted on VLP technology or the specific inter-species genetic mixing this technology represents.

According to National Institute of Health (NIH) documents:

“The underlying technology for the vaccine originated in the laboratories of Drs. John Schiller and Douglas Lowy of the NIH National Cancer Institute. Drs. Schiller and Lowy commenced their research on the molecular biology of HPV nearly 20 years ago. Among their numerous findings, they discovered that the major outer coat protein of the HPV virus, called L1, could self assemble into non-infectious virus-like particles (VLPs) that closely resemble the native outer shell of the actual virus.

The principle behind the vaccine is that exposure to VLPs triggers the immune system to produce protective antibodies. If an individual is exposed to HPV after receiving the vaccine, the immune system already contains the antibodies necessary to prevent virus infection. The antibodies primarily function by preventing the virus from binding to the cell which is necessary in order for the virus to reproduce and thrive.

The catch is that for induction of HPV neutralizing antibodies the L1 must be in the same conformation as in the intact virus. Unlike some other viral vaccines, inactivated virus produced in cultured cells was not a viable option because the viruses could not be produced in sufficient quantities in vitro. Also, the inactivated virions would still contain the viral oncogenes, which would preclude use in healthy young people, the primary target population.

In other words, the vaccine would produce cancer, not prevent it.

Schiller and Lowy demonstrated that large quantities of VLPs could be produced in insect cells (emphasis added) infected with L1 recombinant baculovirus (a genetically engineered protein grown in insect larvae). Critically, they also showed in animal models that the L1 VLPs were able to induce high titers of neutralizing antibodies, comparable to those induced by authentic virions. Furthermore, they and their colleagues demonstrated that L1 VLP vaccination could protect animals from experimental challenge with high dose virus of the corresponding animal papillomavirus (emphasis added) types and that human and animal papillomavirus (emphasis again added) L1 behaved similarly in the ability to assemble into VLP.”

While individual papilloma virus types tend to be highly adapted to replication in a single animal species, researchers have already identified inter-species transmission of papilloma virus in rabbits and cattle. The evolution of papilloma viruses is slow compared to many other virus types. It is believed that papilloma viruses generally co-evolve with a particular species of host over many years.

The long term results of introducing into the human body genetically engineered, recombinant human, insect and animal DNA, along with human and animal strains of papillomavirus are unknown, untested and unproven, particularly when used as a vaccine, which effectively bypasses all of the body`s natural defenses against outside pathogens (skin, saliva, mucous, etc.)

The current deaths and maiming of young girls used as guinea pigs to test this new technology may be just the beginning.

No one can predict what adverse consequences this newest inter-species gene mixing technology may cause. Remember we are dealing with the reproductive systems of an entire generation of young woman.

Furthermore, the two strains of HPV which the vaccine purportedly protects against account for only 70% of all cervical cancers, leaving at least 30% of these young girls with no protection against cervical cancer. To call this a cervical cancer vaccine is a tragic deception.

In addition, many health care experts have publicly predicted that cervical cancer deaths will increase sharply, with routine Pap tests foregone under a false sense of security that Gardasil has made them immune to cervical cancer (and not just the two strains of alleged cancer causing HPV for which the vaccine claims efficacy).

The fact that the vaccine is not effective in girls already exposed to the virus, yet parental supervision is mandated during the interview to determine if the recipient is sexually active, further undermines the ability to discern “qualified” candidates for this potentially dangerous, new, experimental, unproven, falsely promoted vaccine technology. Imagine a 16 year old girl who does not want to confess that she has been sexually active to a parent stating that she has not and then being administered this drug. According to a reported Merck document, if this young girl has previously been infected with HPV, she has just increased her risk of developing high grade pre-cancerous lesions of the cervix by 44.6%.

It was reported to the FDA as early as October 30, 2006 by letter. Sin Hang Lee, M.D., a practicing pathologist wrote to Dr. Steven I. Gutman, Director, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), Center for Devices and Radiological Health (CDRH), FDA, enclosing the manuscript of a scientific report titled “Human Papillomavirus Genotyping by DNA Sequencing-The Gold Standard HPV Test for Patient Care,” which was submitted to a professional journal to be considered for publication. The purpose of the letter was to inform the FDA that a more sensitive and more specific device is being introduced for detection of HPV in clinical samples and for preparation of materials for HPV genotyping and to request advice and guidance from the agency for making this device available to hospital laboratories at the point of care . With this letter and manuscript, the FDA was informed of the need for a new generation of HPV testing based on new information available because:

1) A sensitive HPV detection device that can provide accurate genotyping information is needed for following patients with persistent infection that is now recognized to be the tumor promoter in cancer induction.

2) A PCR-based HPV detection device with provision for accurate HPV genotyping is more urgently needed now because vaccination with Gardasil of the women who are already sero-positive and PCR-positive for vaccine-relevant genotypes of HPV has been found to increase the risk of developing high-grade precancerous lesions by 44.6%, according to an FDA VRBPAC Background Document: Gardasil HPV Quadrivalent Vaccine . May 18, 2006 VRBPAC Meeting. www.fda.izov/ohrms/dockets/ac/06/br… [14].

Page 10 of the attached document included this statement:

The introduction of the type-specific Gardasil HPV vaccines among the sexually active women also requires genotype monitoring of the HPV infections before and after immunization to develop prevention strategy for the individual patients. Based on a `Background Document” submitted to the FDA by Merck & Co., Inc., injection of HPV vaccines into women who have concurrent vaccine-relevant HPV type infections may increase the risk, by 44 .6%, of developing high-grade precancerous lesions in the cervix. Therefore, it would be prudent to perform a sensitive HPV detection assay with accurate genotype determination on the patients to be vaccinated if prior HPV infection is suspected.

Recombinant DNA, genetically engineered proteins, inter-species gene mixing, questionable new vaccine technology, lack of long term safety and efficacy data, questionable pre-qualifications procedures and now, an extremely high prevalence of reported adverse side effects up to and including miscarriage and death.

This vaccine represents more than just bottom line profit for Merck. This is the first genetically modified drug unleashed across a broad swath of unsuspecting, formerly healthy Americans.

Unfortunately, the target they chose for this grand genetic experiment is the entire female population of mothers to be for all future generations. Can we really afford to allow this fraud and deception to continue?

Sources:

What Are the Key Statistics About Cervical Cancer? via American Cancer Society website
Human Papillomaviruses:Natural History and Virology, Elizabeth R. Unger Ph.D.,M.D. via FDA website
NIH Technology Licensed to Merck for HPV Vaccine via NIH Office of Technology Transfer website
FDA Press Release P06-77: FDA Licenses New Vaccine for Prevention of Cervical Cancer
and Other Diseases in Females Caused by Human Papillomavirus
Christensen ND (2005). “Cottontail rabbit papillomavirus (CRPV) model system to test antiviral and immunotherapeutic strategies”. Antivir. Chem. Chemother. 16 (6): 355-62. PMID 16331841
Calleja-Macias IE, Villa LL, Prado JC, et al (2005). “Worldwide genomic diversity of the high-risk human papillomavirus types 31, 35, 52, and 58, four close relatives of human papillomavirus type 16″. J. Virol. 79(21):13630-40 doi:10.1128/JVI.79.21.13630-13640.2005. PMID 16227283
RECLASSIFICATION PETITION FOR Human Papillomavirus (HPV) DNA Nested Polymerase Chain Reaction (PCR) Detection via FDA website

About the author

Herb Newborg is president at Chiropractic America. Chiropractic America and Ogilvy PR Worldwide firm, Feinstein Kean Healthcare (FKH), have developed www.YourSpine.com along with a national marketing communications program to educate patients about the importance of spinal health and better align the chiropractic profession with consumer healthcare and wellness issues. FKH is a nationally-recognized leader in healthcare communications and public relations. Chiropractic America leverages FKH’s extensive healthcare experience to elevate public awareness and perception of chiropractic and ultimately drive informed and motivated patients to chiropractors nationwide.
Our mission is to educate consumers about the important role their spine plays in their overall health. We communicate the role chiropractors play in maintaining health by maintaining the integrity of the spine and nerve system. Well-educated, informed patients are equipped with the knowledge to take control of their health.

This article was originally published in the Natural News  on Friday, February 13, 2009 by: Herb Newborg, citizen journalist.

For the full article and additional resources go to : http://www.naturalnews.com/025613.html

©2012 An Inconvenient Woman. All Rights Reserved.

Reported by David Jolly

With the purchase, Merck is expanding its franchise in cardiovascular, respiratory and oncology drugs and shoring up its research pipeline, in particular with a Schering-Plough product called TRA, a promising drug designed to prevent blood  clotting.

In addition, Merck will benefit from the worldwide reach of Schering- Plough, which generates about 70 percent of its sales outside the United States, including more than $2 billion in annual revenue from emerging markets.

The companies said in a joint statement that the merged company would keep the name Merck and that the deal had been unanimously approved by their boards. Richard Clark, Merck’s chairman and chief executive, will lead the combined company.

The deal is the second major pharmaceutical deal this year after Pfizer, the world’s biggest drug maker, agreed in January to pay $68 billion for Wyeth. And Roche, the Swiss pharmaceutical company, is pursuing a full acquisition of the California biotechnology company Genentech, in which it already owns a majority stake.

Merck is among the drug makers that face the hardest time in the next decade because of patent expirations, said Richard Purkiss, a drug sector analyst at Atlantic Securities in London. Most pressingly, it faces the expiration in 2012 of the patent on Singulair, the asthma drug that is its top-selling product.

In contrast, “Schering- Plough doesn’t have much exposure to patent expiries in the same time frame,” he said. “This is really about combining to protect earnings.”

Shares of Schering- Plough rose more than 8 percent Friday amid speculation that the company had been pursuing a deal with either Merck or Johnson & Johnson, with which it jointly produces the arthritis drug Remicade.

Under the terms of the agreement announced Monday, Schering-Plough shareholders will receive 0.5767 share of the combined company and $10.50 in cash for each share of Schering-Plough. Each Merck share will automatically become a share of the combined company. Based on Merck’s closing stock price Friday, the deal values Schering-Plough at $23.61 ar share, or $41.1 billion, a premium to Schering-Plough shareholders of about 34 percent.

The 44 percent of the deal that is being paid in cash will include $9.8 billion from existing cash balances and $8.5 billion from financing provided by JPMorgan Chase.

Merck shareholders will own about 68 percent of the merged company, and Schering-Plough shareholders will own the rest. Merck said it expected the deal to contribute “modestly” to its earnings in the first year and “significantly”  thereafter.

“We are creating a strong, global health care leader built for sustainable growth and success,” Clark said in the statement. “The combined company will benefit from a formidable research and development pipeline, a significantly broader portfolio of medicines and an expanded presence in key international markets, particularly in high-growth emerging markets. The efficiencies we gain will allow us to invest in strategic opportunities, while creating meaningful value for  shareholders.”

The transaction will be structured as a “reverse merger” in which Schering-Plough, renamed Merck, will continue as the surviving public company.

Merck said it expected annual cost savings of about $3.5 billion after 2011. The savings “are expected to come from all areas across the combined company and from the full integration of the Merck/Schering-Plough Pharmaceuticals cholesterol joint venture,” it said, and are in addition to previously announced cost-cutting measures at the two companies.

David Moskowitz, an analyst at Caris & Co. in New York, suggested that the companies might have to raise the offer price above $23.61.

“I think it should be at least $12 billion to $15 billion higher,” he told Reuters, as investors might not be happy until the price reaches “the high $20s or $30″ a share.

©2012 An Inconvenient Woman. All Rights Reserved.

Consumers can only  hope. Of course if  MERCK corporate lawyers figure out that such an open source platform may lead to a clear chain of custody of the type of information they would rather not have readily available during a trial environment, we will see who prevails, the scientist or the lawyers

Reported by Kevin Davies

March 3, 2009 | SAN FRANCISCO – Merck scientists and executives Stephen Friend and Eric Schadt unveiled their plans for Sage, an open-access platform for sharing and disseminating complex data representing disease biology, in a major announcement at CHI’s Molecular Medicine Tri-Conference last week.*

In a joint presentation, Friend, Merck senior vice president and former oncology chief, and Schadt, an outstanding researcher based at Merck’s Seattle subsidiary Rosetta Inpharmatics, reviewed the successes and outstanding challenges that prompted them, with Merck’s blessing (in the form of money and resources) to entertain a bold new approach to improving the expense, time and productivity of drug development.

The benefits of analyzing complex bionetworks are very good, said Schadt, but “more expensive than any one company can afford.” The vision of Sage was “to create open access, integrative bionetworks, evolved by contributor scientists, to accelerate the elimination of human disease.” An all-star advisory team includes Nobelist Leland Hartwell, Sir David Lane (A*STAR Singapore), Navigenics co-founder Dietrich Stephan, Merck research chief Peter Kim, Yale’s Rick Lifton, and John Wilbanks (Science Commons).

“We need massive amounts of information appropriately integrated to build models that are predictive,” said Schadt. “Scientists across the globe involved in different areas of research need to be actively engaged in accessing these networks and contributing information back.”

The transition from a linear to a network mindset would require the generation of coherent datasets, the development of predictive models to design novel therapeutic approaches, and the leveraging of social networks and other means to foster a contributor network. “Watching the trends of public data access, we anticipate a transition of disease biology into the precompetitive space,” said Schadt. Friend added, “The concept of making disease biology a pre-competitive space is… something that we feel in the long run has an opportunity [to succeed].”

Schadt said Merck’s leadership had recognized an opportunity where donating some of its data into the public domain, forming an open access platform that will emerge from an incubator phase, would provide a potentially significant long-term understanding of disease biology.

As for why scientists should include their own data, Friend said, “picture chemistry, picture physics. The people who were originally trying to mix compounds didn’t get very far until they found molecular structures… This is the analogy for what’s going to happen in biology.” New representations of disease allow for data to be shared and layered.

The hardest part in making Sage successful may not be the technology, Friend concluded. “It’s either going to be … our institutions … that have a certain culture about what we do with data. Or it’s going to be the clinicians,” who aren’t used to presenting clinical data using defined standards.

Decade of Discovery

Over the past decade, Friend said Merck has introduced numerous bold technologies that have been successful to a degree. Widescale RNA expression profiling in tumors (in conjunction with the Netherlands Cancer Institute) led directly to the development of Mammaprint and Oncotype diagnostic tests for breast cancer metastases. But such measurements are confounded by multiple variables, making it impossible to infer causality.

Merck also championed whole-genome RNA interference (RNAi) screening. “Often we use it to choose what drug should be combined with what standard of care, and what patient is likely to respond to what therapy,” said Friend, such as identifying gene networks that influence the activity of cisplatin. But heterogeneity of samples made it almost impossible to put the results into context. “It’s like looking at a single frame in “Slumdog Millionaire” and going, Ah, that’s what that movie was about,” he said.

A third initiative, beginning around 2002, was to merge databases of clinical information and genetic information. Merck forged collaborations with European and Chinese cancer institutes, as well as the Moffitt Cancer Center, which enables Merck researchers to direct patient selection in clinical trials based on molecular signatures in the database. But Friend said that the volume of disease data amounted to “a clinical/genomic Tower of Babel” problem.

More recently, Merck has been riding the success of Schadt’s team in Seattle, which has taken major steps to harness the explosion of data and analyze biological networks to predict the physiological state of the system. “Drug companies were betting the farm on seeing things correlated with disease and beautiful patterns of expression and then developing drugs, without having any real idea of the casual nature of those patterns,” said Schadt. The key was to leverage DNA information and environmental effects. “To be competitive in the future and to impact human health, we must become masters of information,” Schadt said, displaying a picture of Aria, the all-seeing master computer from the film Eagle Eye.

Ed’S NOTE: Eric Schadt will keynote the 2009 Bio-IT World Expo on Tuesday, April 28.

*CHI’s Molecular Medicine Tri-Conference. San Francisco, February 23-26, 2009.

©2012 An Inconvenient Woman. All Rights Reserved.

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.