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Fiddaman over at www.fiddaman.blogspot.com recently reported that Dr. David Evans has denied an inquest into the death of Sara Carlin daughter of Neil and Rhonda Carlin living in Oakville Ontario.  Sarah died as a direct result of side effects and perhaps withdrawal from Paxil.  Not surprising as many have died of the same thing. http://euchred.com/?p=252
 
 
Dr. Evans feels that such an inquest would not benefit the general public and “a jury would not make useful recommendations that could prevent similar deaths in the future” Dr. Evans are you out of your bloody mind?  Or do you have a friend that works for GSK?  I have to ask this as your decision and your statement is absolute crap and you know it.   http://www.oakvillebeaver.com/news/article/213791
 
Either you are very aware and your decision was based on politics and money or else you are completely unaware and ignorant to the hell Paxil/Seroxat has caused in so many lives.   I can’t imagine the latter to be true although I could be wrong.
 

Sara was a graduate of St. Ignatius of Loyola Catholic Secondary School and an Ontario Scholar when she took her own life after being prescribed Seroxat, despite the fact that this particular antidepressant had been banned for use in patients of her age group.

On Sunday, May 6, 2007, Sara, who had been suffering adverse side effects from Seroxat, took her own life.

Her father Neil and mother Rhonda have been campaigning tirelessly for over a year to find answers so this cannot happen to other children and so good, loving parents to not have to experience the heartache of losing a child as a result of inadequate drug regulations, ignorant doctors and psychiatrists and a non caring pharmaceutical company by the name of GlaxoSmithKline.
 
http://fiddaman.blogspot.com/2008/10/sara-carlins-parents-call-for-inquest.html
 
 
Dr. Evans, you and I can sit down and hash this out over and over again with tens of thousand of other people that will agree Paxil is a very scary drug.   I could argue till I’m blue in the face but what it really comes down to is that Ontario is not protecting the citizens that live here and pay HUGE tax dollars to do so.   You have a job to do and you had better start doing it.   We have tens of millions of people taking SSRI drugs each and every year/worldwide and parents that blindly trust doctors when they carelessly prescribe Paxil off label.  We are not just talking about a handful here.  We are talking about thousand of kids on Paxil.   But you don’t think that an inquest would sever the best interest of the public?  Did you smoke a joint before you decided to make that statement?  How bad does it have to get before it WOULD serve public interest? 
 
Clearly the worst thing that will ever happen to you has not happened yet.  How nice for you.  However, like everyone else that has ever lived, it will and when it does I want you to remember the Carlin family and the hell they have endured as a result of a drug that is extremely dangerous, prescribed to their daughter and should not have been.   The same damn drug that will be prescribed to another child tomorrow.   This case should be used as an example to doctors and patients alike.  How dare you decide that a jury would not be capable of making recommendations?  Do you think they are stupid?  Do you think it’s too complicated?  It is GlaxoSmithKline and doctors that have made Paxil side effects and withdrawal complicated NOT the people that have taken it and suffered from it.  Its pretty straight forward actually.   Let’s not forget that it was the public that pushed awareness in the first place.  People! just ordinary working people with the help of a few good men with degrees that have probably saved many lives simply by creating that awareness.  How long do we have to continue to do your job for you and your colleagues?  
 
 
Dr. Evans you took an oath, and many people have put a great deal of trust and faith in you without even knowing you.  Did you forget that? 
 
“A jury would not make useful recommendations” over the last fifteen years how many doctors or “specialists” in the province of Ontario have made useful recommendations regarding SSRI drugs and children or adults for that matter?  Certainly not the doctor that prescribed Paxil to Sara Carlin.  The world health organizations has cited Paxil as the most difficult SSRI to withdrawal from and in spite of that doctor’s continue to prescribe carelessly and as though it’s a vitamin. 
 
http://www.youtube.com/watch?v=99RWfNVJKlo
 
 
Are you not aware of the scandal with Paxil known as Seroxat in the UK, between GSK and the MHRA?  Do you not understand that GSK was trying to get a pediatric license for a drug they knew to be ineffective in children and life threatening?  Let’s put the manners and political correctness aside for a second.  Basically they were willing to kill kids to make a profit!   If you understand this then please explain, in detail, how an inquest would not be in the public’s best interest.  Watch these videos Evans and tell us how this is not in the public’s best interest!!!  Or have you already?  If you have then you have some explaining to do.
 
 
http://www.youtube.com/watch?v=SwEMDmHUnjI
 
http://www.youtube.com/watch?v=JqPDNbobDk8
 
http://www.youtube.com/watch?v=KMAtkRLgf9o&feature=related
 
http://www.youtube.com/watch?v=T4nKd2Z8bro&feature=related
 
http://www.youtube.com/watch?v=JZGIHMsDH70&feature=related
 
http://www.youtube.com/watch?v=kIXHK0LFD2c
 
 
Everyone living in the province of Ontario should be appalled and sickened by this decision.
 
And to parents living in Ontario and all over the world:
 
This is yet another example of how we allow parents that have lived out our worst nightmare, go to battle alone and without our support.  This effects all of us.  The Carlin family will not get their daughter back no matter how hard they fight, how much sleep they lose, tears they shed or how many Dr. David Evans re-victimize them and their daughters memory  but they are willing to go the distance for your kid and mine.  Don’t you think its time to get off your rump and pitch in?  Sympathy is wonderful but sometimes the human investment actually means doing something. 
 
Get on your computers and start writing letters.  Dr. David Evans (OCCO) needs to be reminded of how vitally important these decisions are to the most vulnerable members of our society and to us, their parents.
 
GlaxoSmithKline should be held accountable and if not you Evans then who?
 
And as for the statement made by GSK on the issue…  You are pathetic.   I’m not going to even bother with you!

Wednesday, 14 March 2007

Dr. Diane M. Harper, a lead researcher in the development of the human papilloma virus vaccine, who says giving the drug to 11-year-old girls “is a great big public health experiment.” AHRP’s stated rationale for objecting to a policy mandating Merck’s HPV vaccine in 11 year old girls is validated by an internationally recognized expert in the field who tested the vaccine in clinical trials.

http://ahrp.blogspot.com/2007/03/nyt-vital-discussion-clouded-mandatory.html

Dr. Harper, a scientist, physician, professor and the director of the Gynecologic Cancer Prevention Research Group at

The Norris Cotton Cancer Center at Dartmouth Medical School in New Hampshire, said: “It is silly to mandate vaccination of 11- to 12-year-old girls There also is not enough evidence gathered on side effects to know that safety is not an issue.”

All of her trials have been with subjects ages 15 to 25.

“This vaccine has not been tested in little girls for efficacy. At 11, these girls don’t get cervical cancer – they won’t know for 25 years if they will get cervical cancer.”

Dr. Harper said, Merck was required to put together a database on the efficacy in children before Gardasil was approved. But instead, the company put together four study sites that “are not necessarily representative, and may not even have enough numbers to determine what they need to know.”

She believes the ideal way of administering the new vaccine is to offer it to women ages 18 and up. At the time of their first inoculation, they should be tested for the presence of HPV in their system. If the test comes back negative, then schedule the follow-up series of the three-part shots. But if it comes back positive? “Then we don’t know squat, because medically we don’t know how to respond to that,” Harper said.

She said that vaccinating little girls now is not going to protect them later. Since it can take a decade or more to even manifest itself as dysplasia, the HPVs against which this vaccine works may infect a little girl at the age she needs the vaccine most – meaning she will have to have a booster at the right point in time or she will not be protected. And, remember, it won’t work at all if she was positive for the virus when she was inoculated in the first place. Merck knows this, Harper said. “To mandate now is simply to Merck’s benefit, and only to Merck’s benefit,” she said. Dr. Harper said, she’s been trying for months to convince major television and print media to listen to her and tell the facts about the usefulness and effectiveness of this vaccine. “But no one will print it,” she said.

Something is very wrong with this commercially driven frenzied marketing which all those who shape public policy and public opinion were caught shilling for Merck.

Independent advocates need to take to the streets to protect our children from irresponsible pharmaceutical companies whose financial largesse buys public officials, government agencies that are supposed to protect us from potentially harmful drugs and vaccines, and the uncritical transcribers of hype in the press! What role did the FDA play in this Gardisal promotion debacle?

Today the FDA ordered manufactures of 13 sleeping pills to add warning labels that sleeping do indeed cause sleep driving!! Imagine 13 different sleeping pills and all of them put pedestrians and drivers at risk of a sleeping driver behind the wheel!!

With the current regime in command, the FDA is lending the government seal of approval to the creation of chemically induced disasters.

Contact: Vera Hassner Sharav

212-595-8974

veracare@ahrp.org

http://www.kpcnews.com/articles/2007/03/14/online_features/hpv_vaccine/hpv01.txt

Researcher blasts HPV marketing

BY CINDY BEVINGTON cindyb@kpcnews.net

Alliance for Human Research Protection

 Source – Natural News

FDA Documents Reveal HPV “Not Associated with Cervical Cancer”

For the last several years, HPV vaccines have been marketed to the public and mandated in compulsory injections for young girls in several states based on the idea that they prevent cervical cancer. Now, Natural News obtained documents from the FDA and other sources (see below) which reveal that the FDA has been well aware for several years that Human Papilloma Virus (HPV) has no direct link to cervical cancer.

Natural News also reported that HPV vaccines have been proven to be flatly worthless in clearing the HPV virus from women who have already been exposed to HPV (which includes most sexually active women), calling into question the scientific justification of mandatory “vaccinate everyone” policies.

Furthermore, this story reveals evidence that the vaccine currently being administered for HPV — Gardasil — may increase the risk of precancerous cervical lesions by an alarming 44.6 percent in some women. The vaccine, it turns out, may be far more dangerous to the health of women than doing nothing at all.

If true, this information reveals details of an enormous public health fraud being perpetrated on the American people, involving FDA officials, Big Pharma promoters, and even the governors of states like Texas. The health and safety of tens of millions of young girls is at stake here, and what this Natural News investigative report revealed is that HPV vaccinations may not only be medically useless; they may also be harmful to the health of the young girls receiving them.

This report reveals startling facts about the HPV vaccine that most people will find shocking:

• How it may actually increase the risk of precancerous lesions by 44.6 percent.

• The FDA has, for four years, known that HPV was not the cause of cervical cancer.

• Why mandatory HPV vaccination policies may cause great harm to young girls.

• Why HPV infections are self-limiting and pose no real danger in healthy women.

• Little-known FDA documents that reveal astounding facts about Gardasil.

• How Big Pharma promoted its Gardasil vaccine using disease mongering and fear mongering.

The Trail of Evidence

This story begins at a company called HiFi DNA Tech, LLC (http://www.hifidna.com) a company involved in the manufacture of portable HPV testing devices based on DNA sequencing analysis. HiFi DNA Tech has been pushing to get the FDA to classify its HPV detection technology as a “Class II” virology testing device. To understand why this is a big deal, you have to understand the differences between “Class II” and “Class III” virology testing devices.

Based on FDA rules, a Class III virology testing device is one that is considered by the FDA to have “premarket approval,” meaning that it cannot yet be sold to the public. In order for such a device to be marketed to the public, it must be downgraded to Class II status, which is considered a “special controls” status. Class II devices are, “…those devices for which the general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but for which there is sufficient information to establish special controls to provide such assurance, including performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendations, and any other appropriate actions the agency deems necessary.”

In other words, a Class II device may or may not actually be safe, but the FDA considers is safe enough to release to the public.

HiFi DNA Tech has been trying to get its HPV detection device downgraded to a Class II device based on the following arguments:

• For more than 20 years, the FDA had regulated the HPV test as a “test for cervical cancer.”

• But since at least 2003, the FDA has changed its position on the relationship between Human Papilloma Virus and cervical cancer, stating that the HPV strain is “not associated with cervical cancer.”

• Accordingly, HiFi DNA Tech is arguing that the HPV test it has developed is no longer a test for cervical cancer, but is merely a test for the presence of Human Papilloma Viruses — a shift that makes the test far more reliable in its primary purpose. In other words, the test is merely detecting the presence of a virus, not making a diagnosis of a disease (which would be a much higher standard to meet).

On October 12, 2007, HiFi DNA Tech sued the Food and Drug Administration in an attempt to force it to downgrade its HPV detection technology to Class II (see http://www.news-medical.net/?id=31180 ). Earlier in the year — on March 7, 2007, HiFi DNA Tech filed the HPV PCR test reclassification petition with the FDA. It is the information in this petition document that led us to the FDA’s knowledge that HPV is not linked to cervical cancer.

Got all that? This is a somewhat complex story to follow, so here it is again in summary:

• A company that manufacturers a DNA testing device that can detect the presence of HPV (Human Papilloma Virus) is petitioning the FDA (and suing the FDA) to get it to reclassify its medical device as a “Class II” device based on the revelation that the FDA has already adopted the position that HPV infections do not directly cause cervical cancer.

• This would mean that the FDA has been aware for years that HPV does not cause cervical cancer, which means that the FDA’s approval of the Gardasil vaccine — as well as the national push for Gardasil vaccinations — is based on a grand medical hoax that, not surprisingly, appears to be designed to exploit the fear of cancer to sell vaccines. The victims in all this, of course, are the young girls who are apparently being subjected to a medically useless (and potentially dangerous) vaccine.

• None of this information was apparently known during the more recent debates over the safety and efficacy of Gardasil, the HPV vaccine now in use. This means that the public debate over mandatory HPV vaccinations lacked key elements that now seem essential to reaching rational, evidence-based conclusions over the safety and efficacy of such vaccines.

Next, we reveal the FDA’s statement that HPV is “not associated with cervical cancer.”

The Text of the Petition

The Reclassification Petition, dated March 7, 2007, is still posted on the FDA’s website: http://www.fda.gov/ohrms/dockets/docket

This document reveals the following text:

The FDA news release of March 31, 2003 acknowledges that “most infections (by HPV) are short-lived and not associated with cervical cancer”, in recognition of the advances in medical science and technology since 1988. In other words, since 2003 the scientific staff of the FDA no longer considers HPV infection to be a high-risk disease when writing educational materials for the general public whereas the regulatory arm of the agency is still bound by the old classification scheme that had placed HPV test as a test to stratify risk for cervical cancer in regulating the industry.

Natural News sought to verify the existence of the FDA news release referenced by this petition reclassification document and found that, indeed, the FDA news release exists. In fact, it’s still posted on the FDA website at http://www.fda.gov/bbs/topics/NEWS/2003…

In it, the FDA says, “The HPV DNA test is not intended to substitute for regular Pap screening. Nor is it intended to screen women under 30 who have normal Pap tests. Although the rate of HPV infection in this group is high, most infections are short-lived and not associated with cervical cancer.” (Emphasis added.)

In other words, the FDA knew in 2003 that HPV infections are not associated with cervical cancer.

Furthermore, the FDA states, in the same press release, “Most women who become infected with HPV are able to eradicate the virus and suffer no apparent long-term consequences to their health.”

In other words, HPV infections do not cause cervical cancer! Remember, the entire push for mandatory HPV vaccinations of young girls across the country has been the urgent call to “save” these young girls from cervical cancer. The vaccine push has been about “savings lives.” But as these documents clearly reveal, HPV is no threat to the lives of young girls. In fact, as you will see below, HPV infections are naturally self-limiting!

HPV Infections Resolve Themselves, Without Vaccines

As the reclassification petition reveals, HPV infections are naturally self-limiting — meaning that they are controlled naturally, without requiring intervention with drugs or vaccines. It is not the HPV virus itself that causes cervical cancer but rather a persistent state of ill-health on the part of the patient that makes her vulnerable to persistent infections.

As the petition states:

“Based on new scientific information published in the past 15 years, it is now generally agreed that identifying and typing HPV infection does not bear a direct relationship to stratification of the risk for cervical cancer. Most acute infections caused by HPV are self-limiting [1, 4-7]. …Repeated sequential transient HPV infections, even when caused by “high-risk” HPVs, are characteristically not associated with high risk of developing squamous intraepithelial lesions, a precursor of cervical cancer.

A woman found to be positive for the same strain (genotype) of HPV on repeated testing is highly likely suffering from a persistent HPV infection and is considered to be at high risk of developing precancerous intraepithelial lesions in the cervix. It is the persistent infection, not the virus, which determines the cancer risk.”

The FDA agrees with this assessment of the relationship between HPV and cervical cancer, as evidenced by its 2003 news release quoted above.

Next, we reveal evidence that HPV vaccines actually cause precancerous lesions in women

Do HPV Vaccines Increase the Risk of Precancerous Lesions?

The reclassification petition cited above also reveals that Gardasil vaccines may increase the risk of developing precancerous lesions by 44.6 percent in some groups of women. This is found in a quote referencing a document mentioned in the petition, which states:

“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.gov/ohrms/dockets/ac/06/briefin…

I tracked down the correct URL of the document referenced above and found it in the FDA docket archives. A backup copy is available at www.naturalnews.com

Sure enough, this document reveals startling information about the extreme dangers apparently posed by Gardasil vaccinations. On page 13, this document states:

“Concerns Regarding Primary Endpoint Analyses among Subgroups

There were two important concerns that were identified during the course of the efficacy review of this BLA. One was the potential for Gardasil to enhance disease among a subgroup of subjects who had evidence of persistent infection with vaccine-relevant HPV types at baseline. The other concern was the observations of CIN 2/3 or worse cases due to HPV types not contained in the vaccine. These cases of disease due to other HPV types have the potential to counter the efficacy results of Gardasil for the HPV types contained in the vaccine.

1. Evaluation of the potential of Gardasil™ to enhance cervical disease in subjects who had evidence of persistent infection with vaccine-relevant HPV types prior to vaccination. The results of exploratory subgroup analyses for study 013 suggested a concern that subjects who were seropositive and PCR-positive for the vaccine-relevant HPV types had a greater number of CIN 2/3 or worse cases as demonstrated in the following table:

Observed

Efficacy
-44.6%

It appeared that subjects in this subgroup of study 013 who received Gardasil™ might have had enhanced risk factors for development of CIN 2/3 or worse compared to placebo recipients.”

Revealing the Dangers of Gardasil

This revelation should be quite shocking to anyone who has been following the debate over Gardasil and mandatory vaccinations of teenage girls. First, it reveals that Gardasil appears to increase disease by 44.6 percent in certain people — namely, those who were already carriers of the same HPV strains used in the vaccine.

In other words, it appears that if the vaccine is given to a young woman who already carries HPV in a “harmless” state, it may “activate” the infection and directly cause precancerous lesions to appear. The vaccine, in other words, may accelerate the development of precancerous lesions in women.

This is information that has simply not been made available in the debate over Gardasil vaccination policies. The pro-vaccination rhetoric has always been about “saving lives” and it carried the implied statement that Gardasil is perfectly safe for all women, posing absolutely no increased risk of cancer. What these documents reveal, however, is that Gardasil may, in fact, pose a serious increase in the risk of cervical cancer in some recipients of the vaccine.

Next: Will health authorities “interrogate” young virgins over their sexual activity (or lack thereof)? What are the bioethical ramifications of this vaccine being mandated to all teenage girls?

Interrogating Young Virgins

The FDA directly admits the vaccine is utterly useless in these women, stating in the same document, “Finally, there is compelling evidence that the vaccine lacks therapeutic efficacy among women who have had prior exposure to HPV and have not cleared previous infection (PCR positive and seropositive).”

What this essentially means is that the “safe” administering of the Gardasil vaccine requires that it be administered only to virgins (because virtually all women who are sexually active carry HPV strains). That, of course, would require the direct questioning of the sexual habits of all young girls before administering the vaccine.

Is this what the Governor of Texas really had in mind when he mandated such vaccinations for all young girls in Texas? … a male doctor with a vaccination needle in his hand and a thirteen-year-old girl sitting in a private clinic room behind closed doors, with the male doctor asking her, “Have you ever had sex?”

Clearly, this kind of patient questioning crosses all kinds of ethical barriers when such vaccinations are made mandatory (as they have been made in Texas). It puts the State in the positioning of ascertaining the sexual habits of very young teenage girls and then potentially causing them harm. It’s not hard to suppose that most sexually active teenage girls would claim to still be virgins (especially if their parents were present), creating a situation where vaccines would be routinely administered to precisely the HPV carrier subgroups for which it has been demonstrated to greatly increase the risk of precancerous lesions.

In other words, under a mandatory Gardasil vaccination scenario like what exists in Texas today, a sexually-active young teenage girl has to make a tough choice:

1. She can lie to her doctor, claim to be a virgin, receive the vaccine and thereby potentially increase her risk of cervical cancer, or

1. She can tell her doctor she’s sexually active, thereby surrendering her privacy and possibly subjecting herself to various consequences from her sexual status being learned by her parents or guardians. (One would hope, of course, that such sexual habits were not secrets, but alas, we live in the real world where many teenage girls do indeed have sex at a very early age…)

Furthermore, the young girl is unlikely to be given accurate information about the health risks associated with the vaccine, since virtually all health authorities are heavily involved in promoting pro-vaccination propaganda, routinely ignoring scientific evidence that might give reasonable people pause.

Naturally, the better scenario here is that the young girl is not sexually active to begin with, but in a society where 8th and 9th graders are already routinely engaged in sexual activities — almost always unbeknownst to their parents — it seems naive to expect that such girls would suddenly honor pledges of celibacy in order to protect themselves from possible future dangers posed by a present-day vaccine (especially when doctors blindly claim the vaccine is harmless).

There are also serious questions about the safety of the vaccine for non-sexually-active young women. Yet even if the vaccine poses no increased risk of cervical cancer for non-sexually-active young girls, there’s still the more serious question of: Does the vaccine work? Does it really prevent cervical cancer in the first place? And that question has already been clearly answered by the FDA’s own admission that HPV infections are not the cause of cervical cancer in the first place.

Next: Do HPV vaccinations help anyone? We reveal a four-quadrant comparison that shows the vaccine to be more harmful than helpful?

The Four Quadrants of Garsadil Vaccinations

When considering the safety and effectiveness of Gardasil vaccinations on young teens, there are essentially four quadrants to consider, as shown in the table below:

Based on what we’ve learned from the FDA’s own documents, here are the likely outcomes of each of the four quadrants:

Quadrant I: Non-Sexually Active, No Gardasil Vaccine

Outcome: No risk of cervical cancer.

Quadrant II: Non-Sexually Active, Receives Gardasil Vaccine

Outcome: No medical benefit from vaccine.

Quadrant III: Sexually Active, No Gardasil Vaccine

Outcome: HPV presence is self-limiting and does not lead to cervical cancer.

Quadrant IV: Sexually Active, Receives Gardasil Vaccine

Outcome: 44.6% Increased risk of precancerous lesions. No reduction in cancer risk.

In other words, Gardasil adds no benefits to any quadrant! There is no subgroup that actually benefits from a Gardasil vaccination. But there is at least one quadrant in which Gardasil achieves an increased risk of disease. Put another way, Gardasil helps no one, but it harms some.

This is hardly a position from which to mandate the vaccine for everyone, especially since the vaccine has been widely prescribed as “completely safe” for everyone. It is widely claimed by medical authorities that the vaccine has no downside: No health risks, no increased risk of disease and no potential to cause harm in women. Clearly, these assumptions have no basis in scientific fact.

Keep in mind, too, that Merck, the manufacturer of Gardasil, has publicly suggested that young boys should receive Gardasil vaccinations! Why? Because they might engage in oral sex with girls who carry the virus. Therefore, the story goes, young boys should be vaccinated against this virus that they claim causes cervical cancer! (Never mind the fact that boys don’t have a cervix…) There is no end, it seems, to the pseudoscientific nonsense that will be spouted in an effort to sell more Garsasil vaccines to people who don’t need them.

Research Shows Gardasil to be Useless

To further investigate this conclusion, NaturalNews took a closer look at research published in the Journal of the American Medical Association (August, 2007), entitled, “Effect of Human Papillomavirus 16/18 L1 Viruslike Particle Vaccine Among Young Women With Preexisting Infection”

This research sought to determine the usefulness of the HPV vaccine among women who already carry HPV (which includes virtually all women who are sexually active, regardless of their age).

This document can currently be found at a University of Louisville document archive reprinted from JAMA. Click here to read the PDF yourself.

Just in case that copy disappears, we’ve also hosted the PDF here: http://www.NaturalNews.com/downloads/HPV…

This document reveals startling information about the ineffectiveness of the Gardasil vaccine. It reveals that the HPV vaccine often caused an increase in the presence of HPV strains while utterly failing to clear the viruses in most women.

These shocking results caused the study authors to publish this sobering conclusion, printed in JAMA:

“No significant evidence of a vaccine therapeutic effect was observed in analyses restricted to women who received all doses of vaccine or those with evidence of single HPV infections at entry (Table2). We observed no evidence of vaccine effects when we stratified the analysis on selected study entry characteristics reflective of [various parameters] (TABLE3). Similarly, no evidence of vaccine effects was observed in analyses stratified by other study entry parameters thought to potentially influence clearance rates and efficacy of the vaccine, including time since sexual initiation, oral contraceptive use, cigarette smoking, and concomitant infection with C trachomatis or N gonorrhoeae (Table 3).”

In other words, the authors found no evidence that the vaccine worked at all. This observation led the authors to offer this damning conclusion that appears to render Gardasil nothing more than a grand medical hoax:

“… rates of viral clearance over a 12-month period are not influenced by vaccination.”

The study goes on to state words that should cause every doctor, Governor and health authority across the United States (and around the world) to rethink Gardasil vaccination policies:

“…given that viral clearance rates did not differ by treatment group and that persistent viral infection is the best established predictor of risk of progression, it is unlikely that vaccination could have a significant beneficial impact on rate of lesion progression.1,17

Results from our community-based study provide strong evidence that there is little, if any, therapeutic benefit from the vaccine in the population we studied. Furthermore, we see no reason to believe that there is therapeutic benefit of the vaccine elsewhere because the biological effect of vaccination among already infected women is not expected to vary by population.

In other words, the vaccines didn’t work on the population studied, and there is no reason to believe that those same vaccines would magically work on other populations, since the biology of women and HPV is so similar across various populations.

The Conclusion: HPV Vaccinations a Medical Hoax

It is difficult to take an honest look at this scientific evidence and the statements made by the FDA and not come to the conclusion that mandatory Gardasil vaccination policies being pushed across U.S. states right now are based on something other than science.

There are many theories exploring the motivation for such vaccination policies. Possible theories include:

Financial benefit: Big Pharma is pushing mandatory Gardasil vaccination policies so that it can profit from selling more vaccines to the states. This idea is at least partially supported by the fact that the first state Governor to mandate such vaccines (Texas Gov. Rick Perry) had undisclosed ties to Big Pharma. (A top official in Perry’s administration worked directly for Merck, the manufacturer of Gardasil.)

Conspiracy to poison the people: This theory, which may stretch the bounds of belief in some readers, proposes that such mandatory vaccines are put in place in order to create future disease by poisoning the people with dangerous chemicals and DNA fragments that are knowingly added to vaccines. The poisoning of the people, it is said, will pay off in future profits for Big Pharma when those people develop other serious diseases requiring “treatment” with medications. Many people who support this theory currently believe, for example, that AIDS was engineered by human scientists and then administered to the gay population in New York in the late 1980’s through vaccines.

Control the sheep: This theory supposes that the main purpose of mandatory vaccines is to train the American public to get used to submitting to compulsory medicines. Once a certain segment of the population is targeted and effectively injected with mandatory medicines, these policies can be extended to other groups and, eventually, can encompass the entire population.

The first theory-Financial Benefit- is the simplest and easiest theory to believe. It requires nothing more than simple greed on the part of Big Pharma, along with the usual level of corruption at the FDA. I believes this is the most likely explanation for events surrounding Gardasil vaccination policies, but I would not do rule out other possible explanations, either.

Profits at Any Cost

What’s clear in all this is that mandatory HPV vaccination programs are not based on anything resembling good science. They seem to be based on a carefully planted meme — an idea that, coincidentally, spreads from one person’s mind to the next much like a virus, gaining momentum as the mainstream media (MSM), health authorities, FDA and drug company reps repeat the meme on a regular basis. And what is that meme? That HPV causes cervical cancer, and, therefore, HPV vaccinations could halt cervical cancer and save lives.

This meme appears to have no real scientific basis. It is more of an urban legend than anything resembling scientific fact. Furthermore, it appears to have been conjured by those in a position to financially benefit from the adoption of that meme (the drug companies who manufacture, sell, and profit from the sale of HPV vaccines). In this case, that drug company is Merck, a powerful corporation with a dubious history rife with charges of price fixing, large-scale tax avoidance (it set up offshore accounts to avoid billions in U.S. taxes), widespread biopiracy, conspiring with the FDA to discredit its critics, burying negative evidence about its drugs (see the history of Vioxx at www.NaturalNews.com/vioxx.html ) and numerous other actions that many consider to be criminal in nature.

There is no question that Merck has the lack of ethics, the willingness and the means to commit medical fraud on an unprecedented scale. Based on the information revealed in this report, the mandatory vaccination of young girls with Gardasil appears to be the boldest medical hoax yet perpetrated by the company. You can read the true history about Merck and its crimes at: http://www.NaturalNews.com/Merck.html

Many believe Merck is currently engaged in a massive medical fraud, and that it has influenced, corrupted or otherwise recruited FDA officials and state health authorities in a grand scheme to sell vaccines that are at best medically worthless, and at worst medically dangerous. Halting cervical cancer seems to have nothing to do with the marketing and prescribing of Gardasil. The entire campaign push for mandatory HPV vaccinations seems to be based entirely in the realm of sales and marketing.

The “marketing” of HPV vaccines involves classic disease mongering — spreading fear about a disease as a way of corralling patients into begging for the “solution” that just happens to be readily available from the same pharmaceutical company that promoted the disease in the first place. The hype over cervical cancer and Gardasil seems to be nothing more than a classic case of fear-based marketing designed to create such consumer fear over cervical cancer that a massive public outcry would result in legislation mandating the vaccines.

Sources Cited

HiFi DNA Tech files lawsuit against FDA http://www.news-medical.net/?id=31180

Reclassification Petition – Human Papillomavirus (HPV) DNA Nested Polymerase Chain Reaction (PCR) Detection Device (K063649) http://www.fda.gov/ohrms/dockets/docket…

FDA Approves Expanded Use of HPV Test http://www.fda.gov/bbs/topics/NEWS/2003…

VRBPAC Background Document, Gardasil™ HPV Quadrivalent Vaccine, May 18, 2006 VRBPAC Meeting http://www.fda.gov/ohrms/dockets/ac/06/…

Effect of Human Papillomavirus 16/18 L1 Viruslike Particle Vaccine Among Young Women With Preexisting Infection Journal of the American Medical Association, August, 2007.

Natural News

http://www.naturalnews.com/Report_HPV_Vaccine_0.html

I’ve been through it, Paxil withdrawal that is. I still don’t know how the hell I did it.  How did I get off of it while others are unable? I know my experience was severe. I told my daughter I would be off of it before she graduated and I was. I think it was that promise that I needed to keep no matter how intolerable it was. I wanted so much to tell her “Its over- I’m off it now” She was a rock during the ‘Paxillian days’. She made light of it when she could and if she ever suffered (I’m sure she did) she hid it well for everyone’s sake. But those are years her and I will never get back. Months of hiding in my room and unable to leave the house. Weeks in the bathroom, carrying around a bag in the car just incase my stomach defied me. More often than not, it did!. 

It always started the same way. I knew the drill as I been through it so many times before. That flu like feeling which quickly evolved into something much more insidious. I have read and listened to other people tell me that it took a couple of days before withdrawal hit. Not for me. I always started to feel shitty an hour or so before my regularly scheduled dose anyway so going over was not an option.

Paxil addiction and withdrawal was not something I had anticipated when I was prescribed the drug.  As like most everyone else, our doctors did not have a clue that such a monster existed with this drug [they still aren't] and if they did they weren’t willing to share that information. [They still aren't] 

The first time took me by surprise. I went to my GP and told him to get me the hell off Paxil. He reduced my 90mgs by 30mgs. I thought I would die. Actually, I nearly did.  In the beginning it was trial and error. My doctor was useless so learning how to control the invisible monster was up to me.  It was the most desperate time of my life, one I will never forget. I would not wish it upon anyone which is why I’m here in the first place. My Paxil days are over. You could not pay me enough money to take an SSRI’ ever again. I am not doing this for me although it began as a way to vent my anger and frustration. When I realized the truth about Paxil and other SSRIs – I was sickened. Paxil scares the hell out of me. To know, that as I write this, there is someone, somewhere going through what I did, has kept me here, unwilling to keep my mouth shut! This fact alone should give people an idea of how awful it was for me and for everyone else that has endured it. Had the suffering been mild to moderate, had the withdrawal only taken 4 weeks, we all would have moved on with our lives and forgotten about Paxil but severe Paxil withdrawal is not something anyone could easily forget. For some there are long term effects.

There were times when I would run out of my prescription. For one reason or another; I was unable to get the Paxil until the following day or God forbid, a few days later. I remember feeling as though I would kill someone to get it. The shakes were awful. I felt like a desperate illegal drug user scrambling around to get another pill. I would tear the house apart hoping I had left one out of the bottle, in the bathroom, or some stupid thing like that. Every now and again I would find one that I had left on the night stand. I remember one day, when I had been to the cottage for a few weeks, I called in for my next prescription but they did not have any. Our cottage is about 40 minutes from the nearest pharmacy and unlike the city life I’ve become accustom to, small towns shut down at 5pm, it was 4:30 pm and they had not bothered to call me back and tell me they had run out of it earlier in the day. The pharmacist seemed unconcerned that I would have to go a day or two without it. I wanted to rip her head off and I nearly did. I totally lost my composure right there at the back of the drug store and in front of quite a few people. My husband drove us back to the cottage.  By 2 am I was literally on the ground hoping to find one on the floor. When that failed and the shakes were no longer controllable, when the anxiety attacks were shooting out of me so badly that I could barely think clearly (something I had never experienced prior to Paxil) I poured a few shots of Vodka straight from the bottle. (Not something I would recommend)

I went through six doctors during my ‘Paxillian’ days. Some of them were really nice and I hate to say anything negative of them. I know that they don’t know or didn’t back in 2004-2006. There were other doctors that were absolute idiots and nurses that should be working in factories, not with people. Finally, I found one doctor that had some knowledge and experience with this so called “phenomena” which is more common than what he lead me to believe but nevertheless, he released me from hospital with some understanding of what was happening. Finally, I had some knowledge and we knew enough to withdraw more gradually. That did not mean I would not experience much of anything thereafter. I certainly did, but knowing that the withdrawal was not me completely losing my marbles made the difference between life and death. Had it not been for him, I doubt I would be here today.

Dr. Meir Steiner from Hamilton’s St. Joseph’s hospital did a recent study on Paxil and Premenstrual dysphoric disorder [PMDD]. His research proved to him that women could benefit from Paxil for their monthly curse. I think that Dr. Steiner needs his head read! There is no way that Dr. Steiner did this study without knowing what we all know now about Paxil and yet he still feels that Paxil is worth the risk for severe Premenstrual syndrome [PMS]. His entire theory, surely backed by GlaxoSmithKline, contradicts everything GSK has told us in Paxil’s defense. They have said that people that commit suicide or homicide in the initial first few weeks of treatmentment, did so because the drug did not have enough time to take effect on their depression thus the drug had nothing to do with the end result.  Yet Steiner and GSK are now saying that women will benefit by taking this drug for a week or so each month. Are they now admitting that Paxil does have short term effects and that the drug becomes active quite quickly and far more quickly than what they have been saying for over a decade? I think lawyers; representing class action law suits should really take a good look at this new theory of theirs. There has always been this ongoing debate about individuals that have taken their lives within the first week or less of treatment. Are they now saying the opposite? They change the profile of their own drug whenever and however it suits them.

I know that many people believe GSK’s marketing department are quite bright and I would agree that they have mastered the art of manipulation but I really do think they are also quite good at shooting themselves in the foot.  Had GSK not tried to get a pediatric license for their Paxil they would have avoided a lot of negative press and been able to keep everyone in the dark much longer than what they have. Uneducated doctors would still be walking around handing out prescriptions to unsuspecting children and those trials would still be a big secret. Doctors are still doing this all over the world but not in the numbers they were prior to the release of this information.

Greed got the better of them. And now that they have enabled Dr. Meir Steiner to go public with his little experiment on women by providing lawyers with a new argument they did not have before.  GSK is handing it to them on a silver platter. Maybe they [GSK] are happy with Steiner’s findings? They did after all fund this particular research. They have made no comment – a standard tactic by Pharma.

GSK are hogs with no shame.  Greed is a doubled edged sword.  I wonder if they have ever heard the expression “Pigs get fed- Hogs get slaughtered”

Paxil should be classified as a controlled substance. With an alleged 50 million people on SSRIs we need a withdrawal program and fast.  We have been needing this for a very long time. I hope Bob Fiddaman tells this to the MHRA when he meets with them in September. I hope the MHRA listens to him and takes this very seriously. The public needs to get over what the MHRA did not do to help them in the past. Unless they do something in the near future the past will be a shadow that follows them around until hell freezes over because we won’t shut up.  We now need to know that there is a drug regulator somewhere in the world that is willing to do what needs to be done so that others may follow suit. Who knows, maybe the MHRA will lead the way? I, for one, sincerely hope so.

Good Luck Bob Fiddaman

Princess

Investigations Continue into Psychiatrists-Big Pharm Ties

Jul 25, 2008 | Parker Waichman Alonso LLP

I found this tonight when i was sifting through the internet- I really want these doctors to be held accountable. 

Studies have shown that researchers paid by a company are more likely to report positive findings when evaluating that company’s drugs. The private deals can directly affect patient care, said Dr. William Niederhut, a psychiatrist in private practice in Denver who receives no industry money.

Recently we reported that Grassley was demanding the American Psychiatric Association provide an accounting of its financing.  “I have come to understand that money from the pharmaceutical industry can shape the practices of nonprofit organizations that purport to be independent in their viewpoints and actions,” Grassley said in a letter to the association.  In 2006, the latest year for which numbers are available, the drug industry accounted for about 30 percent of the association’s $62.5 million in financing, with half that money going to drug advertisements in psychiatric journals and exhibits at the annual meeting; the remainder sponsored fellowships, conferences, and industry symposiums at the annual meeting.

Dr. Alan F. Schatzberg of Stanford and the association’s president-elect has $4.8 million stock holdings in a drug development company.  Dr. Melissa P. Dobell of the University of Cincinnati reportedly worked for eight drug makers and told university officials that from 2005 to 2007 she earned about $100,000 in outside income.  Meanwhile, AstraZeneca told Grassley it paid DelBello over $238,000 in that period, making some of those payments through MSZ Associates, an Ohio corporation DelBello established for “personal financial purposes.”  In June, Grassley reported to Congress that Dr. Joseph Biederman, a renowned child psychiatrist at Harvard Medical School, and a colleague, Dr. Timothy E. Wilens, reported to university officials earning several hundred thousand dollars apiece in consulting fees from drug makers from 2000 to 2007.  They actually earned at least $1.6 million each.  Another Harvard group member, Dr. Thomas Spencer, reported earning at least $1 million after being pressed by Grassley’s investigators.

A Vermont study found that on average, psychiatrists who received at least $5,000 from makers of newer-generation antipsychotic drugs appear to have written three times as many prescriptions to children for the drugs as psychiatrists who received less or no funding.  The drugs prescribed are not approved for most uses in children, who appear to be especially susceptible to the side effects.

A spokesman for Grassley’s office said the senator is looking into 30 physicians from up to 20 universities, but wouldn’t comment on any specific doctors.

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The following expose’ was first published in May of 2004. It was updated and edited sometime around 2005-2006 by Rob Robinson. To date, it represents the most comprehensive and detailed history of Paxil known to the public.

What you are about to read is a distillation of several months worth of intensive Internet-based research completed using a high speed cable modem coupled with a Macintosh “G4″ computer. Along the way the author, Rob Robinson, received a couple of crucial pieces of information from novelist (and Paxil survivor) Patricia Griffon, author of the Pulitzer-nominated Blind Reason along with a little help from “lady luck” herself. Robinson’s travels whisked him through the Internet as if it were a 20th century version of “Alice In Wonderland’s legendary looking glass” tumbling head over heels into the hinterlands of cyberspace. Incredibly, it all began when he stumbled across a single record; one buried and long forgotten in a United States government cyber database almost 25 years ago.

Penetrating so many secrets we cease to believe in the unknowable.
But there it sits nevertheless, calmly licking its chops.”

H.L. Mencken

Ferrosan

In the 1960’s a small Danish company called Ferrosan entered into (according to their web site) a successful venture into CNS (Central Nervous System) research, which led to the discovery and launch of the antidepressant Paxil (a.k.a Seroxat), now owned by GlaxoSmithKline.”

Ferrosan is almost always referred to as a Danish company but in a document issued by the United States Federal Court of Appeals concerning a highly technical and convoluted patent dispute (SmithKline Beecham Corporation and Beecham Group, P.L.C. v. Apotex Corp., Apotex, Inc., and Torpharm, Inc.) relative to paroxetine Ferrosan is referred to as “a British company.” In any event, Ferrosan was a family owned enterprise; the Danish part of the group remained so until 1986 when it was acquired by Novo Industri A/S (now Novo Nordisk A/S). After the acquisition, the CNS (Central Nervous System) research activities, the distribution of prescription medicine, and the veterinary medicine activities were all merged into the corresponding divisions of Novo Industri A/S.] (The suit just mentioned was resolved on April 23rd, 2004 in favor of Apotex Corp., Apotex, Inc., and Torpharm, Inc.)

Leading the research team of Ferrosan was an individual, Dr. Jorgen Buus-Lassen, who supported the theory that the specific enhancement of serotonin might lift a depressive mood. But Dr. Buus-Lassen was not a doctor in the ordinary sense of the word, but rather a “DVM” or “Doctor of Veterinary Medicine.” (In plain English: Buus-Lassen is licensed to be an animal doctor.) Buus-Lassen received his DVM credentials from the Royal School of Veterinary and Agriculture Science in Copenhagen. (Note: Buus-Lassen’s first name sometimes appears as Joergen.)

Buus-Lassen and his associates at Ferrosan explored approximately 100 compounds before concocting the one that the world would come to know as “paroxetine” and, ultimately, Paxil in the United States.

Ferrosan filed a patent application (#598,146) with the United States Patent and Trademark Office on July 23rd, 1975. (A similar application was made in the UK on January 30th, 1973.) The U.S. application was a continuation-in-part of patent application #435,006, filed January 21, 1974 (now U.S. Pat. #3,912,743) relating to novel 3-substituted 1-alkyl-4-phenylpiperidines having interesting pharmacological properties which make them useful as antidepressants and anti-Parkinson agents. The Ferrosan patent record references two prior U.S. patents:

· An application (with 10 claims) for a U.S. patent concerning “ethers of 2-piperidylphenylmethanols” submitted on July 17th, 1958 (#749,075) by Robert Michel Jacob, Ablon-sur-Seine and Nicole Marie Joseph (Paris, France), assignors to Societe des Usines Chimiques Rhone-Polenc, Paris, France, a corporation of France. The application was approved, and U.S.Patent #2,976,291 was issued on March 21st, 1961. A “claims priority, application France August 1st, 1957 is noted.

·  An application (with 5 claims) for a U.S. patent concerning “2-benzyl-3-hyproxy and lower alkoxy piperidines” submitted on February 6th, 1963 (#256,536) by Robert L. Clarke, Bethlehem, N.Y., assignor to Sterling Drug Inc., New York, N.Y., a corporation of Delaware. The application was approved, and U.S. Patent #3,178,438 was issued on April 13th, 1965.

The relevancy of these earlier patents has not been ascertained.

Jorgen Buus-Lassen’s first paper on paroxetine was published in 1975.

U.S. patent #4,007,196 was issued by on February 8th, 1977 to Ferrosan. The 196′ patent claims paroxetine and its salts and discloses their antidepressant properties.

Interestingly enough, Buus-Lassen was not listed as Paxil’s (paroxetine) inventor; that was credited by Ferrosan to Jorgen Anders Christensen (Virum, DK) and Richard Felt Squires (Gl. Olstykke, DK). These individuals were Ferrosan associates of Buus-Lassen. Nevertheless, Buus-Lassen is considered the “father” of Paxil today. (Perhaps “grandfather” would be more appropriate.) Later though, Buus-Lassen was listed as “inventor” when Ferrosan applied (#804,810) to the USPTO on December 4th, 1985 (and in Britain on December 4th, 1984) to use Paxil (paroxetine) in the treatment of obesity. On May 17th, 1988 Ferrosan was accorded U.S. Patent #4,745,122 for that indication. (Ferrosan also lists Buus-Lassen as inventor for at least two more U.S. paroxetine-related patents: #4,585,777 on April 29, 1986 and #4,593,036 on June 3rd, 1986.

Ferrosan later developed a process to produce the crystalline hydrochloride salt of paroxetine, or paroxetine hydrochloride (PHC).

In 1980, Ferrosan licensed the #4,007,196 patent and its other “PHC-related technology” to SmithKline. SmithKline began manufacturing PHC in its Harlow plant in England.

In March 1985, a chemist in SmithKlines Worthing, England laboratory, Alan Curzons, created a new crystalline form of PHC while attempting to improve PHC production. Curzons test results established that the new product was the hemihydrous form of PHC (PHC hemihydrate), while Ferrosan’s original form was anhydrous PHC (PHC anhydrate). PHC anhydrate comprises crystals of PHC without bound water molecules. PHC hemihydrate comprises PHC crystals with one bound water molecule for every two PHC molecules. PHC hemihydrate proved more stable and thus more easily packaged and preserved.

Further review of the SmithKline samples showed that the Harlow plant had unwittingly made PHC hemihydrate as early as December of 1984.

In May 1985, SmithKline began double-blind clinical tests in the United States to determine the “safety and efficacy” of PHC hemihydrate capsules to treat depression symptoms.

On October 25, 1985 SmithKline filed a patent application in the British Patent Office relating to crystalline paroxetine hydrochloride, its preparation and its uses as a therapeutic agent. The British application identified the invention as both the hemihydrate and the anhydrate form of PHC, as well as mixtures that contain a major portion of either form.

On October 23, 1986, SmithKline filed a U.S. application claiming priority to a British application that issued as the #4,721,723 patent in 1988. The 723 patent does not claim PHC anhydrate and does not claim mixtures of the two PHC forms.

If you would like to peruse the U.S. patent records concerning paroxetine (Paxil) visit the USPTO web site

In 1989 Buus-Lassen wrote a piece entitled “Introduction to the development of paroxetine, a novel antidepressant.” The article was a terse four paragraphs. Of those, two were single sentences. At the bottom of the page were nine footnotes. [Acta psychiatr. scand. (1989) 80:13.]

In an April 28, 2002 interview with British newspaper “The Guardian” (see The Chemistry of Happiness) Buus-Lassen was quoted, saying It (paroxetine) didn’t work with all patients. In most studies we could just show that we had about the same efficacy as the older tricyclic antidepressants. We didn’t see a better effect.”

SmithKline Beecham and “the Gates Of Hell”

Beecham patent #4,007,196 licensing in hand from Ferrosan after merging with another drug company called SmithKline & French (to become SmithKline Beecham a.k.a. SKB), would eventually become the company responsible for flinging wide the laboratory “gates of hell,” thereby allowing Paxil to find its new home in the medicine cabinets of America (and the world.)

But before Paxil could be sold in the United States SKB had to gain approval from the Food And Drug Administration certifying Paxil as “safe and effective.” So in the 1980’s SKB undertook a series of Paxil human clinical trials. Although the drug was tried on SKB employees, most interesting were those conducted in Yugoslavia in the late 1980’s. To SKB’s dismay the Yugoslavia trials were an unmitigated disaster; the company was having a hell of a time coming up with tests they could present to the FDA demonstrating the drug was safe and effective. Billions of dollars in projected profits were imperiled. So what did SKB do? Using a bit of “the devil’s math” they “fixed” the studies so Paxil would “wow” the FDA. (Which, many years later, led to the following lawsuit citing fraud by SKB (now GSK) It is believed that a small but critical change in Paxil’s product information label came about as a result of this lawsuit being filed.)

Exiting Yugoslavia (bogus studies in hand) SKB submitted Paxil’s application to the FDA.

Through a combination of agency ineptitude and to some what appears to be collusion, Paxil was approved by the FDA for sale in the U.S. a few months subsequent to a October 5th, 1992 agency review of the drug.

Paxil’s official FDA approval date is December 29th, 1992.

In 1993, SmithKline placed “its” antidepressant drug (with PHC hemihydrate as the active ingredient) on the market under the name Paxil. (For the record: Paxil was actually first sold in the UK, in 1991, under the trade-name “Seroxat.”

What has resulted is a mind-boggling swath of human misery cutting across the lives of countless thousands of individuals who took Paxil. Now, in 2005 and 13 years after Paxil was introduced in the U.S. it appears the carnage is far from over. For that the public can thank, in part, football legend Terry Bradshaw who was hired by GSK to aggressively promote Paxil. (Bradshaw has been called the “Pied Piper of Paxil” for his role in luring thousands of unsuspecting new victims over the edge and into depths of “the Paxilian abyss.”)

But the real story of Paxil is only beginning. For reasons still not ascertained a trademark for Paxil was applied for on March 28th, 1980 with the United States Patent and Trademark Office (under “Goods & Services”) as a hypnotic drug for human use. But not by Ferrosan or Beecham, but by a German drug company called Boehringer Ingelheim G.m.b.H.

Note: The official registration date for the Boehringer Ingelheim trademark is listed as September 29, 1981 and a “termination” date of April 7, 1988.

The existence of this seemingly (at first glance) “run of the mill” record educed an extraordinary question: Did Boehringer Ingelheim enter into a joint venture with Ferrosan in the 1960’s whereupon Jorgen Buus-Lassen was provided the (approximately) 100 compounds he and his associates tested  out of which came Paxil?” Ferrosan was a relatively small company. As such, it is unlikely the company produced the compounds, but rather obtained them “off the shelf” from a much larger company with the resources to make them like Boehringer Ingelheim. What followed was, in all likelihood, an agreement whereby Boehringer Ingelheim told Ferrosan if it came up with anything marketable from the compounds they would handle the marketing and distribution.

If this is not the case, then why did Boehringer Ingelheim and not Ferrosan, or Beecham (later merged with SmithKline to become SmithKline Beecham) register Paxil on March 28th, 1980, with the United States Patent and Trademark Office? The only logical explanation it seems is Ferrosan and Boehringer Ingelheim had a business agreement regarding Paxil; one that apparently went “poof” the very same year Ferrosan licensed SmithKline the #4,007,196 U.S. patent, along with its other “PHC-related technology.” Whatever the case, this Ferrosan Boehringer Ingelheim connection warranted a closer look at the latter company.

But before doing that, there’s a quite bit more to that Boehringer Ingelheim trademark registration worth considering:

· Why did Boehringer Ingelheim classify Paxil as a “hypnotic” and not an antidepressant? That was not a random designation; either Ferrosan or Boehringer Ingelheim, must have conducted research and studies that indicated this was the best way to, pharmacologically speaking, describe the drug’s effect. (Where, one might wonder, is that data now? In GlaxoSmithKline’s confidential company archives?)

· Why did SKB begin selling Paxil in the United States as an antidepressant and not a hypnotic?

· How was “Paxil the hypnotic” transformed by SKB into “Paxil the antidepressant”? After all, hypnotics are central nervous system (CNS) depressants. (Webster’s dictionary defines a hypnotic as Any agent that produces, or tends to produce, sleep: an opiate; a soporific; a narcotic. (One medical dictionary simply defines a hypnotic as a “sleeping-tablet”.) Does it matter? Perhaps not. However, sticking with the hypnotic label for Paxil might have prompted the FDA to classify the drug as a controlled substance (Which Paxil should be.) Or, perhaps it would have made it impossible to position Paxil in the U.S. marketplace to compete with Lilly’s multi-billion dollar Prozac profit engine … which was being peddled as an antidepressant. Or maybe all of the above.

Whatever the case, one has to wonder if Paxil is soon destined to end up in the pharmaceutical trash-bin of history just like another hypnotic, called Halcion did.

Boehringer Ingelheim: “Black Widow” At the Center of the ‘SSRI Web’?

Boehringer Ingelheim is one of the twenty largest drug companies in the world; it has strategic partnerships with many other multi-national pharmaceutical corporations, including SSRI giants GlaxoSmithKline and Eli Lilly as well as a new company called NeuroSearch which is headed up by none other than the “father of Paxil” himself Jorgen Buus-Lassen.

Probing the history of Boehringer Ingelheim, it was discovered the company had garnered some bad press after it was widely reported, under the direction of Richard von Weizsacker, had supplied the United States government with large quantities of a highly toxic and dangerous herbicide called dioxin (a.k.a. “Agent Orange”) during the Vietnam War. Weizsacker eventually left the company and went on to become president of the Federal Republic of Germany in 1984.

Interestingly, Weizacker’s father, Baron Ernst von Weizsacker, served as state secretary in the foreign ministry of the German Republic from 1938-1943; in 1949 he was sentenced at the Nuremberg trials to seven years imprisonment for “crimes against humanity.” Specifically, he was convicted for his use of diplomatic pressure to make possible the deportation of Slovakian and Italian Jews to Nazi death camps. His sentence was later commuted to “time served.”

In the 1990’s, a study published in the journal of the United States National Cancer Institute provided conclusive evidence of a direct relationship between industry and the cancer-causing effects of dioxin. Generally ignored by the mainstream press, the study revealed that many thousands of workers in the U.S. chemical industry died of various cancer-related illnesses as a result of exposure to dioxin. Pooling data from more than 5,000 workers from 12 different factories across the United States, the study found that workers with the highest dioxin exposure had a 60 percent greater risk of dying from cancer than the U.S. national average.

It turns out dioxin was discovered in Hamburg, Germany in 1954 at the company of C.H. Boehringer  by a scientist named Karl Heinz Schulz while conducting a series of experiments using “76 assorted Boehringer products.” (The ultimate parent company of the Boehringer Ingelheim corporation is C.H. Boehringer Sohn. Boehringer Ingelheim GmbH, which is a subsidiary of C. H. Boehringer Sohn, is the central holding company for administrative purposes the corporate central body which manages and directs the worldwide family of Boehringer Ingelheim companies and which delivers central services to all companies of the corporation.

Schulz’s dioxin experiments used live rabbits. Schulz would rub the ears of a control group of the animals with one of the 76 Boehringer chemicals. A second group of rabbits housed alongside the control group in open cages was not treated with a test chemical. A few days after the first experiment commenced hideous boils appeared on the test rabbits’ ears. Incredibly, the untreated rabbits in the cages next to the test rabbits were also affected even though they did not come in direct contact with one of the chemicals. Instead, they began dying of liver necrosis (a condition whereby liver tissue practically rots). Schulz concluded the untreated rabbits were inhaling the chemicals applied to the control group rabbits. The one thing that all of the chemicals being tested had in common? They contained varying amounts of dioxin.

Subsequent to his rabbit experiments, Schulz reported to his employer that the compounds containing dioxin were, in his opinion, too deadly for any conceivable use.

What did Boehringer management make of Schulz’s report? They didn’t like it, because the company wanted to unload many of the compounds into the American market so they hid the test results. Boehringer subsequently sold most of these compounds to Dow Chemical in, as best can be ascertained, 1960. One of the compounds sold to Dow Chemical was the isolate dioxin.

Interestingly enough, a year prior to the sale of the dioxin et. al. rights to DOW it was reported that a representative of the United States Army Chemical Corps traveled to Boehringer to see what he could find out about dioxin’s potential use as a chemical weapon. Based on his report the U.S. military concluded dioxin was too dangerous to be handled safely, although it didn’t stop them from using the chemical as a defoliant (sprayed from airplanes) to clear vast tracts of lush vegetation in Vietnam during the Vietnam War. Elsewhere, estimates were uncovered that suggest as many as one million Vietnamese died as a result of exposure to dioxin. Countless other Vietnamese were seriously poisoned as were untold thousands of American soldiers. Little wonder the chemical was described as the most poisonous chemical in the world in a 1991 article that appeared in “The Mirror” in Germany. Dioxin, it seems, could (and perhaps should) be classified as a weapon of mass destruction.

Digging further into Boehringer Ingelheim’s history an effort was made to ascertain what the company was doing in the 1930’s and 1940’s when Germany was controlled by the Nazi party. Specifically, what activities did Boehringer Ingelheim engage in during Hitler’s reign that would prompt it after the collapse of the Third Reich to join the German Forced/Slave Labor Compensation Fund? Did it have anything to do (as reported by the Shoah Project) with Boehringer “Compound 2516″ studies ordered by Heinrich Himmler and carried out under the aegis of “Dr.” Claus Shilling at the Dachau concentration camp?

· Go to the Google search engine and type in these three words: “dachau” “boehringer” and “2516″. One of the first links that will appear should read “Shoah Project Dokumentation KZ Dachau.” Immediately right of this phrase click on the text that reads Translate this page.

· A new web page will appear with German text translated into (approximate) English. Scroll down to the bottom of the page to the following passage which reads (verbatim):

Professor Dr. Claus Schilling
a set of experiments with the malaria preparation Boehringer 2516 let
accomplish. None of the 1200 chose ever in agreement explained
themselves or freieillig announced themselves. For these attempts
clergyman were often selected. The prisoners were infected by the
injection of the mosquitoes themselves or by injections of Extracten
from the Schleimdruesen of the mosquitoes with malaria.

Further research led back to the late 1800’s whereupon it was discovered (according to The Rise and Demise of Cocaine by Paul Gootenberg) that C.H. Boehringer & Sohn had “jumped into the cocaine trade” and were involved in the business for several decades (possibly well into 1940’s through World War II.)

Leaping forward to modern times, it was discovered Boehringer Ingelheim is the manufacturer of an experimental AIDS drug called “Viramune” (nevirapine). The drug is being used in “clinical trials” involving infants and children at a place in New York’s Washington Heights called “Incarnation Children’s Services” as well as at Columbia Presbyterian and, in fact, at hundreds of participating hospitals in pediatric AIDS clinics nationwide. Coincidentally, GlaxoSmithKline (formerly SKB) is participating in these “studies” with two of its drugs: Retrovir (AZT) and Epivir (3TC, lamivudine). Res ipsa loquitur: For further details visit “The House That AIDS Built”

Cymbalta: Spawn of Boehringer Ingelheim and Eli Lilly

In November, 2002, Boehringer Ingelheim and Eli Lilly (Prozac’s manufacturer) signed a long-term agreement to work together and develop the commercialized use of a compound called duloxetine hydrochloride. Duloxetine, (trademark named “Cymbalta”) was developed as a “dual purpose” drug capable of treating “stress urinary incontinence” as well as depression. (Lilly and its stockholders are counting on Cymbalta to be its next blockbuster antidepressant, since Prozac has gone off patent and profits have gone “poof.”) In late 2004 Cymbalta was approved by the FDA as “safe and effective.” But how safe and effective? Read Philadelphia Inquirer article Suicide Of A Human Guinea Pig.

A Family Reunion of Sorts: Boehringer Ingelheim and Buus-Lassen

Boehringer Ingelheim is also heavily involved with Jorgen Buus-Lassen (formerly of Ferrosan, creator of Paxil) who is now head of his own company called NeuroSearch (a Danish biopharmaceutical company listed on the Copenhagen Stock Exchange: NEUS: CO)

For its part Boehringer Ingelheim is investing a total of DKK 680 million in exchange for sales rights to a drug for Alzheimer’s and Parkinson’s disease that NeuroSearch is developing. Boehringer Ingelheim has agreed to take on the future development costs of the drug. According to Buus-Lassen: It (the agreement with Boehringer Ingelheim) is the most important agreement in NeuroSearchs history. The cash injection ensures that we can develop the drug for the ever more prevalent Alzheimer’s and Parkinsons disease and bring it to market.

“All About NeuroSearch”

NeuroSearch was founded in April of 1989 by Buus-Lassen and five fellow researchers (Asger Aamund, Jrgen Drejer, Frank Wtjen, Leif Helth Jensen, Henrik K. Moltke and Peter Wulff) who left Ferrosan and struck out on their own, pledging their homes to get a startup loan. They first opened shop in a cellar at Danochemo (which specializes in laboratory medical equipment) based in Ballerup, Denmark. They obtained private financing in the amount of DKK 29.7 million for start up capital.

Today, Neurosearch is still located in Ballerup, Denmark (between the Copenhagen (DK) area and Skania in Sweden) in the so-called “Medicon Valley” which, as of October, 2002, was home to 26 hospitals and 12 universities with 4,000 researchers and 135,000 students. The area provides over 30,000 jobs in more than 160 biotechnology companies.

NeuroSearch’s goal is to become an international leader in pharmaceutical research and development, with an intense focus on the central nervous system. The company intends to develop each of its compounds “in-house” to maximize the opportunity for potential profits. In other words: It won’t buy bulk compounds “off the shelf” to experiment with like Ferrosan did in the 1960’s.

Typically, NeuroSearch tries to broker agreements with large pharmaceutical companies to “optimize development and/or marketing.” At the same time NeuroSearch seeks to preserve commercial rights for its compounds in the Nordic and Baltic countries “with the possibility of expanding these primary markets to larger parts of Europe.”

NeuroSearch operates under an “in-house as long as possible followed by collaboration” model based on the following concepts:

· “Collaborations established during the late clinical phases of a compound’s development are generally more profitable than those started during the initial stages.”

· “A gradual increase in NeuroSearch’s capabilities in the areas of drug development, manufacturing of compounds on a larger scale for extended clinical trials and, in the long term, sales of marketable products.”

NeuroSearch currently has agreements not only with Boehringer Ingelheim and GSK (as noted above) but also Abbott Laboratories, along with partnerships enjoining Pharmexa and Pierre Fabre, and equity interests in eight biotech companies, including Bavarian Nordic A/S, NsGene A/S, and Sophion Bioscience A/S.

“The SSRI Ties That Bind”: NeuroSearch, Buus-Lassen and GSK

NeuroSearch’s first accord involving GlaxoSmithKline came in 1993 with then Glaxo Group Research Ltd.

Ten years later and on December 13th, 2003, NeuroSearch and GlaxoSmithKline (which remember, now owns the patent for Paxil first licensed to SKB from Ferrosan the company Buus-Lassen used to work for) announced a landmark five-year research and development alliance. The alliance comprises a number of research programs, including the treatment of purported “diseases” of the central nervous system.

NeuroSearch compound NS2710, intended to treat the “disease of anxiety,” was originally slated for distribution by pharmaceutical giant Pharmacia & Upjohn; however, “problems” arose during the clinical “Phase II” human trials. Not that the compound wasn’t “effective” according to NeuroSearch, but rather some patients experienced sedation or an allergic reaction (i.e. NS2710 knocked them out or made them sick.) The disclosure of these problems was serious enough that Pharmacia & Upjohn immediately ended the partnership. (Perhaps NS2710 has been relegated to “veterinary use only.” Or perhaps a variation of it will turn out to be GSK’s “new Paxil.”)

For the “disease of depression” GSK and NeuroSearch were, until March of 2002, banking on the success of compound NS2389 hyped as a “triple action,” or “mixed monoamine re-uptake inhibitor.” Recently though, abnormal cell growth (i.e. cancer) observed in experiments on rats and dogs scuttled further development.

The world will likely be hearing much more hype about mixed monoamine re-uptake inhibitors (MMRI’s for short) in the near future. In a 2002 interview with the Guardian, a British newspaper, Buus-Lassen spoke of early clinical studies that suggest MMRI’s work on some patients who do not respond to “serotonin enhancement” alone. But we still have to learn and see if this is right, he says. Until we’ve had a full program, it’s still a kind of prediction. We have many pieces, but we don’t know why not all patients are being cured. Several pieces we do not understand. (Cured? By a Buus-Lassen drug?)

What Buus-Lassen didn’t mention in his interview with the Guardian is the fact that an older class of antidepressants, commonly referred to as “tricyclics,” also inhibit monoamine re-uptake. And it was SSRIs, like Paxil that were according to drug company propaganda a great leap forward over the tricyclics in efficacy. The world now knows this is not the case.

According to Dr. Robert Temple, Associate Director for Medical Policy United States Food and Drug Administration who (on Monday, September 11th, 2000, during the course of a public hearing conducted under cover of the FDA Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee) said ….the new antidepressants do not differ in effectiveness from the old antidepressants.

It appears GSK and NeuroSearch are simply “recycling” tricyclics and repackaging them as “new and improved.” (Triple action, no less!)

GSK-NeuroSearch’s NS2359 is intended for the treatment of “Attention Deficit Hyperactivity Disorder,” or ADHD. In a number of pre-clinical models, NeuroSearch’s scientists claim to have shown NS2359 “improves” the function of the neurotransmitters dopamine, nor-adrenaline and serotonin. On the basis of these pre-clinical (and clinical Phase I results) NeuroSearch anticipates NS2359 will provide a better “therapeutic effect” in the treatment of patients (mostly children) purported to have ADHD.

NS2359 has been tested in 125 healthy volunteers in five Phase I clinical studies, and is alleged to be “well tolerated.” In another study involving 54 volunteers (carried out by Professor K. Wesnes, Cognitive Drug Research Ltd.) it was “proven” NS2359 increases attention and improves the ability to recall verbal information.

NeuroSearch initiated a Phase II study with NS2359 at three clinical centers in the U.S. The study included 100 adult (so called) “ADHD patients,” of which 50 were treated with a half milligram of NS2359 once a day, while the other 50 received placebo. The stated goal of the study was to gauge the efficacy of NS2359 in the treatment of ADHD symptoms as well as its “tolerability.” The treatment period was eight weeks, and the study was expected to be finalized in 2004.

NS2359 has also been studied in cocaine addicts in collaboration with the United States National Institute on Drug Abuse.

Watching Every Neurosearch-GSK Move: “Eli Lilly on the Prowl”

Undoubtedly pharmaceutical giant Eli Lilly is watching this development very carefully, because if NS2359 eventually passes the cursory FDA “sniff test” then its own ADHD drug “Strattera” might have a new competitor to deal with one backed by GSK’s own mega marketing machine.

Strattera is a selective nor-epinephrine re-uptake inhibitor (SNRI). To see the sales pitch for Strattera visit the Lilly web site. In 2004, visitors were welcomed to the Strattera web site by three smiling girls leaning on one another’s shoulder in a sort of “Norman Rockwell” knock-off pose. One presumes they were taking the drug and loving it. (Or maybe they were just models.) Visitors are provided an “opportunity” to find out if they are “living with ADD” by taking an online “screening test.” Strattera is “approved by the FDA” for use in children and adolescents  as well as adults who Lilly further targets using glitzy TV “infomercials” and glossy full-page magazine ads under cover of seeking to educate the public about the “grown up” version of ADHD, or Adult “Attention-Deficit Disorder.” According to Lilly, many adults have been living with the condition but don’t recognize it because its symptoms are often mistaken for a stressful life. Lilly suggests: If you’ve felt this type of frustration most of your life, you may have Adult ADD; a condition your doctor can help diagnose and treat. (After what- a five minute visit with a doctor one hounded by a Lilly professional sales rep to prescribe Strattera?)

Back to the NeuroSearch-GSK Hydra

Before heading too far off on a tangent (albeit one that might lead to yet another equally interesting inquiry) let’s revisit that corporate Hydra borne of GSK and NeuroSearch: Under the terms of the five-year agreement NeuroSearch will receive some “triple action” funding a total of EUR 82 million (DKK 610 million) in guaranteed payments from GSK. NeuroSearch will further receive EUR 46.8 million (DKK 348 million), comprising EUR 29.1 million (DKK 217 million) of up-front and research payments, and EUR 17.7 million (DKK 132 million) for 616,000 new NeuroSearch shares to be issued to GSK. The shares correspond to an 8.7% increase of the share capital equal to GSK having a strategic equity interest in NeuroSearch of 8.0% after the capital increase. The purchase price of DKK 214 per share of DKK 20 represents a 30% premium to the average market price over thirty days before the agreement was signed. For new development candidates selected by GSK, the terms of the agreement continue until the patents’ regarding the selected candidates expires. The agreement may only be terminated by GSK in case of NeuroSearch’s insolvency, material breach or in case the controlling interest in NeuroSearch is transferred to a new owner.

Perhaps this deal is, in an oblique manner and after the fact, a way for GSK to say “thank you!” to Buus-Lassen for inventing Paxil which last year earned GSK several billion dollars  just like it has for many years now.

Regarding the GSK-NeuroSearch agreement Dr. Tadataka Yamada, Chairman of Research and Development at GlaxoSmithKline, fawned: Diseases of the central nervous system are particularly debilitating and represent a massive unmet medical need. Combining the skills and resources of GSK and NeuroSearch will accelerate and augment our current efforts to make effective new treatments available to patients as quickly as possible. GSK particularly values the collaborative culture at NeuroSearch, which bodes well for the success of our alliance.

Dr. Yamada, by the way, was one of the top GlaxoSmithKline executives deposed in the 2001 Donald Shell Paxil homicide/suicide case which GlaxoSmithKline lost in spectacular fashion. Here’s just a smattering of what Yamada had to say (in this instance about drug warning labels) when questioned under oath by Houston attorney Andy Vickery:

Dr. Yamada: ….We also have the pressure to understand that our (GlaxoSmithKline’s) drugs aren’t safe and that every drug  although every drug  every drug has potential complications but the benefits outweigh the risks.

Andy Vickery: And in that context, what is the importance of proper labeling as a means to accommodate these two competing interests? We need to get this drug out there on the one hand to people but the drug might hurt some people. Can that be ameliorated in some degree by proper labeling?

Dr. Yamada: That is the hope. That is the hope. It’s not  it’s not always been borne out, and so the FDA is rethinking about what they want to do, how they actually control the physician. I mean one of the problems is that  Maybe I’m saying too much here, Chuck. (Note: “Chuck” is GSK’s counsel.)

Andy Vickery: I can’t ask you what he said yesterday, but I bet one of them was just answer his questions. But I appreciate your helpfulness.

Dr. Yamada: It’s like a pack of cigarettes. You see on there Surgeon General’s warning.

Andy Vickery: Right.

Dr. Yamada: Nobody pays any attention to it.

Andy Vickery: Right.

And another excerpt from the Yamada deposition:

Andy Vickery: Dr. Yamada, as a physician, clinician, academician who not only practiced medicine but taught other doctors how to practice medicine for many years, would you agree that as a general proposition that if language appears in the warnings section in boldface that it is more likely that doctors will take heed of that information than if it’s put back in the post-marketing surveillance section and it’s not in boldface?

Dr. Yamada: Well, my experience would be that doctors just don’t look at the label, period. Now, it could be because I was in an academic institution and that’s what we did. Maybe we felt that we were more up-to-date and therefore we didn’t need no label. I don’t know, but my experience is that most physicians don’t look at the label very carefully. And I’m not certain  I personally am not certain whether it would make a difference whether something was in a black box or in a warning section or in a precaution section, and if you would ask 20 young physicians, I’m not sure they could tell you the difference between those three.

Andy Vickery: Do you know that in the information disseminating process one of the truly important ways that your company communicates both the indications and the side effects of your medications to doctors is through the  I forget what title we were using about the detail men, as I call them, the people that call on doctors?

Dr. Yamada: Yes.

Andy Vickery: That’s a very important conduit for information; isn’t it?

Dr. Yamada: I believe it is, yes.

Andy Vickery: And do you know that your people are trained, your salespeople that call on doctors are trained to emphasize and reemphasize information that is in the warning section of the labels to doctors for the very reasons that you talk about?

Dr. Yamada: I believe so, but I don’t know for a fact.

Andy Vickery: Okay, sir. How are you doing comfort wise?

Dr. Yamada: I’m fine. I’m fine.

Andy Vickery: Any time you want to take a break

It seems fitting to conclude the history of Paxil by closing with a quote from Jorgen Buus-Lassen, the “father” of Paxil. Doing business (again) with Boehringer Ingelheim. Now head of his own company, NeuroSearch, and joined at the hip with GSK which owns Paxil.

I am pleased that we were able to conclude this important strategic alliance with GSK as our two companies have had a well-functioning and trustful partnership within depression research for three years. I have a strong expectation that this extended partnership will be a major success for both companies. This agreement is one of the most important milestones in our history and is a major recognition of NeuroSearch’s competencies within research and development. The agreement significantly increases the generation of value in NeuroSearch and strengthens our financial resources considerably.