June 2013 - Page 2

New Research: PEDF for Endometriosis Relief

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Jordan Davidson

Recent research out of Tel Aviv, Israel has discovered a new potential treatment for endometriosis using pigment epithelium derived factor (PEDF).

Endometriosis, a secondary autoimmune disease estimated to affect 176 million women worldwide occurs when the lining of the uterus (the endometrium) is found outside of the uterus.  These rogue endometrial cells can cause chronic pain, abnormal bleeding and can lead to fertility issues. When a woman’s endometrium builds up during her menstrual cycle, new blood vessels are formed within the thickened uterine lining.  This creation of new blood vessels, also known as angiogenesis, can also be seen in the endometrial cells that grow outside of the uterus in women with endometriosis.  This abnormal blood vessel growth can have painful consequences.

Based on preliminary clinical studies of rodents (induced with endometriosis), an injection of PEDF, an anti-angiogenesis factor produced within our bodies, can reduce endometrial lesions and decrease pain.  Women with endometriosis have higher levels of vascular epithelium derived factor (VEDF) which promotes the abnormal and painful vascularization seen in the pelvic endometrial growths.  To counteract the abnormal VEDF levels, researchers injected PEDF as a replacement therapy in hopes of balancing reproductive angiogenesis.  Once injected with PEDF the mice had a complete reversal of all symptoms and eradication of endometrial lesions.  The study also showed that PEDF has no negative impact on fertility or ovarian quality.

Now that researchers have confirmed PEDF exists within the reproductive system, they hope to commercialize the protein for therapeutic purposes.

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Sex in a Bottle: the Latest Drugs for Female Sexual Desire

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Sex in a bottle

The 21st century quest for female sexual satisfaction comes not from romance, courting or even Kama Sutra type sexual prowess, but from the lab. Forget passion, forget lithe bodies moving rhythmically, forget needing to woo a woman, forget having any skill whatsoever in bed; why bother with any of that when you can get sex in a bottle. Every man’s dream right? Apparently, not. Sexual moirés what they are, there is nothing more frightening than a sexually hungry woman. With the newest, and dare I say, pharmacologically most interesting female desire drugs in clinical trials, concern over the potential explosion of female nymphomania is palpable. According to the New York Times reporter covering the story:

“…what if, in trials, a medicine proved too effective?” laments one scientist … and the FDA rejects “an application out of concern that a chemical would lead to female excesses, crazed binges of infidelity, societal splintering.”  

“You want your effects to be good but not too good,” says Andrew Goldstein, who is conducting the study in Washington. “There was a lot of discussion about it by the experts in the room,” he said, recalling his involvement with the development of Flibanserin, “the need to show that you’re not turning women into nymphomaniacs.”

And women, well, they’re not sure whether to jump for joy about the new drugs or bear arms against the 18th century misogynist perspective of female sexuality. I’m pretty certain no one worried about turning men into sex-crazed cads, the 8-hour Viagra induced erections or the potential blindness from said erections. (Fun fact: the same erection promoting enzyme blocked by erectile dysfunction drugs Viagra, Cialis, Levitra is also found in the retina and when blocked excessively can cause blindness). When all was said and done, a good, solid erection was considered beneficial in and of itself, no matter the cost. Lo, get those women going and watch out. Sex crazed and hysterical, they might upset generations of cultural oppression. Unless, of course, it’s used to maintain the monogamy and monotony of marriage, then by all means pop a libido pill.

The Quest for Female Sexual Desire in a Bottle

Sexual politics aside, these new sexual arousal drugs portend great things for the bedrooms of many. Though developed for women, I suspect they will be cross-marketed to men, almost immediately.

Called Lybrido and Lybridos, the two compounds address sexual desire both above and below the belt. These drugs combine a sexy mix of peppermint coated, testosterone to make you horny, coupled with the erection promoting, genital-blood-flow increasing Viagra (Lybrido), plus a boost of adrenaline with an indirect dopamine kicker (Lybridos). If that isn’t a chemical cocktail to promote copulation, I’m not sure what is. It is Lybridos that intrigues me most and here is why.

Motivating the Brain to Want Sex

Sex begins in the brain and there dopamine is king. Dopamine is the neurotransmitter released with all pleasurable activities, licit and illicit. Our brains are hardwired to seek pleasure via the dopamine reward system. Experience a little pleasure, get a boost of dopamine. Get too much dopamine and addictive behavior or psychosis ensue. Too little dopamine and there is no pleasure and no motivation to seek pleasure.

Adding a bit of dopamine to a hormonally primed and engorged sexual response system would seem to facilitate not only the pleasure response associated with the sexual act itself, but would likely increase the chances that future goal directed behavior would be initiated to sustain or repeat the sexual activity – and to take the drug again. And that is why this drug is so cool, but also, potentially addictive.

A Sex Drug and Sex Addiction

Though the crude and frankly misogynist comments about inducing nymphomania warrant scorn, there is a very real possibility that this cocktail could be addictive. Think about it, combining the pleasure of sex with a boost of dopamine is the perfect addiction. Really, who wouldn’t want to have hot sex, repeatedly. And if taking a small dose of the drug increases sexual pleasure to certain degree, then would taking more of the drug increase the pleasure to a greater degree? Can someone overdose on these drugs? (You know someone will try). Conversely, if one takes the drug repeatedly, does the dose necessarily have to increase to maintain the same level of pleasure?

Because Lybridos enhances sex, a pleasurable, dopamine and endorphin releasing activity in its own right, by increasing dopamine while simultaneously enhancing libido and genital sensitivity, the possibilities for addiction are high. Therein lies the rub. Not only could this be the perfect combination of behavioral and pharmacological addiction, but pleasurable sex threatens every puritanically ingrained, social moire we have, for men and women. Create a drug that makes sex more pleasurable, make that drug and that behavior addicting and social structures will change. Perhaps, not such a bad thing.

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Progesterone in Poetry – Can it be done?

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I got some progesterone in my eye
And now my vision is slow
My acuity is hungry and yet
Not sure what to eat –
Except for potato chips
Or perhaps chocolate
Followed by potato chips,
Chocolate, and
French fries.

Each eyelash wants to take a nap –
But each one also wants
To take a nap, separately,
But with the cat.

I got some progesterone in my eye
And now my eyelid is much heavier
Than normal,
And my eye itself
Is slightly miffed
At my heavy, cheerful eyelid –
But just too apathetic
To address the issue.

I got some progesterone in
My eye
And although
I have plenty of work to do,
I’ll gaze fatly out this convenient window
And not look very hard
At any one thing.

 

Lisa lives in Homer Alaska with her amazing husband, and is an advocate for endometriosis awareness, education, and higher standards for women’s health worldwide.  She works in Quality Assurance, and she dreams of saving the world with poetry and organic vegetables.  She is currently pursuing a Master’s Degree in Project Management. 

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Rolling the Dice with the HPV Vaccine

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If you are the parent of a minor child, you most likely have heard about one or both of the HPV (human papillomavirus) vaccines currently on the market. A trip to the pediatrician’s office with a teen or pre-teen is typically where the first discussion takes place. The doctor will dutifully recite information. HPV is the most common sexually transmitted virus in the United States. As a parent, that gets your attention. They go on to further state that the vaccine will protect your child from the strains of the virus that most commonly cause cervical cancer in females and genital warts in males. These are both very uncomfortable subjects for most of us. However, as parents, we want to protect our children at all costs from anything and everything possible.

As with any vaccine, the parent is provided a pamphlet or sheet containing the standard information: what is HPV, why get vaccinated, who should get vaccinated, and the obligatory safety information. After reading the information and listening to the doctor’s recommendation explaining that the vaccine is very safe (and it seems to be for most patients), many parents make the decision to have their child protected. I was one of them. I rolled the dice and sadly, my daughter lost.

The information pamphlet states that the vaccine has been used in the United States for about six years and has been very safe. You are warned about pain and swelling of the injection site, fever, headache, and the most troublesome side effect, fainting. The patient is required to remain in the doctor’s office for a period of time after the injection as a safety precaution.

What the information pamphlet does not address is that over 29,300 injuries and 136 deaths have been reported following HPV vaccines. Vaccine injury reporting is voluntary in our country and the Center for Disease Control acknowledges that adverse events, as they are called, may be 10 to 100 times greater than those actually reported. Do the math.  The reported numbers seem very significant to me, but I am the mother of one of the injured. I trust we can all agree that the actual numbers could be staggering.

The list of new medical conditions being reported following the HPV vaccine is also staggering, I counted 144 conditions. My daughter has 31 of them. She suffers mainly from neurological, autoimmune, and adrenal issues. The worst offender is a migraine-like headache that has been present every day, all day and night for more than a year. The neurologist refers to it as migraine-like because all the symptoms are there yet it does not respond to any medication. Her immune system has also been compromised. She suffers from leaky gut syndrome and now has sensitivity to 20 common foods. Dealing with this for more than a year now has taken a toll on her 16-year-old body. Chronic pain has lead to depression and adrenal fatigue. All of this in a girl who had what was described as an “unremarkable’ medical history prior to vaccination.

While my daughter’s symptoms are grave, she really is one of the lucky ones.  Many of the injured suffer from daily seizures or even multiple seizures per day.  My daughter does not. For that, I am thankful every day. Having a child in crisis is hard. Having a child with a medical crisis that medical doctors do not know how to reverse is even more difficult. My decision to protect her, in fact, caused her great harm.

Choosing to give your child a vaccination is a personal decision, but it is one that should not be taken lightly. Do your own research, do not simply rely on the information pamphlet, it is, after all, written by the vaccine manufacturer. I learned this lesson the hard way.  When you decide if you will roll the dice, please, for the sake of your child, remember this:  Education conquers fear and knowledge is power.

Gardasil Cervarix HPV Vaccine Research

Hormones MatterTM is conducting a large scale assessment of symptoms and adverse reactions associated with the HPV vaccines, Gardasil and Cervarix. If you, your daughter, other family member or friend have had either of these vaccines, we encourage you to take this important survey. The data collected with help delineate the range, severity, frequency and onset of health symptoms associated with Gardasil and/or Cervarix. For more information or to take the survey: The Gardasil Cervarix HPV Vaccine Survey.

 

 

 

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Gardasil Autopsies Reveal Cerebral Vasculitis

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Chandler Marrs

Controversy about Gardasil and Cervarix related injuries surrounds the HPV vaccine. Almost to a tee, major medical centers, presumed thought leaders, post market surveillance, regulatory agencies and the press, promote the safety of these vaccines. It is incomprehensible to these organizations that such a perfect vaccine could cause serious injury or death. Any new report suggesting otherwise is quickly and summarily rejected, the families of the young women injured or killed are lambasted.  Rarely, does anyone standup and support the injured, lest they too be considered among the fringe. All the while, girls and women and their families continue to be injured or even worse lose their lives, by what pro-industry PR suggests are unexplained reasons.

Well, explain them damn it. If it is not the vaccine, then what? Neither the post-vaccine reactions nor the deaths are random and though the culprits may be complicated, basic human decency, not to mention medical ethics demand that we make an effort to understand the causes of the adverse reactions so that we might prevent them.

Looking for Clues

A group of researchers from University of British Columbia are attempting to do just that –  to understand the constellation of adverse reactions reported post vaccine. In one of their latest reports, published last fall in the open access journal Pharmaceutical Regulatory Affairs, they uncovered evidence of a deadly and difficult to diagnose condition called cerebral vasculitis.The syndrome fits clinically based on the presentation of symptoms reported. The study is not without problems and certainly not without criticism from industry. Here is a review and my thoughts on the research and the reactions to the study from industry and regulators.

What is Vasculitis?

Vasculitis is an autoimmune mediated attack within the walls of the blood vessels, that weaken and sometimes necrotize or kill the vessel. The central feature of vasculitis is the inflammatory destruction of the blood vessel. Vasculitides, as they are called, can develop anywhere in the body, in large or small vessels. Where the vasculitides develop and the size and type of vessels involved determines the types of symptoms that present and how the functioning of the injured physiological system will be affected.  As a result, the symptoms often appear heterogeneous and non-specific, making vasculitis very difficult to diagnose – unless one was looking for it. This report suggests that we ought to begin looking for it.

Peripheral and Cerebral Vasculitis

When vasculitis occurs in the body – peripheral or systemic vasculitis, symptoms include but are not limited to:

When vasculitis develops in the central nervous system – the brain and the spinal cord, symptoms include but are note limited to:

  • nerve problems (including numbness, muscle weakness, and pain)
  • severe headaches that last a very long time
  • strokes or transient ischemic attacks (“mini-strokes”)
  • forgetfulness or confusion
  • delirium and/or depressed consciousness
  • problems with eyesight (likely problems with hearing, but no cases cited)
  • speech problems
  • emotional regulation problems
  • seizures or convulsions
  • encephalopathy (swelling of the brain)
  • sensation abnormalities

Cerebral vasculitis, also called autoimmune encephalitis, represents one of the rarest forms of vasculitis because it requires the toxin or mediator to cross the blood brain barrier. Current estimates suggest an annual incidence of only 1-2 cases of cerebral vasculitis per million adults. Cerebral vasculitis is also the most deadly, as the immune system mediated attack of the small to medium blood vessels in the brain often leads hemorrhagic or ischemic stroke and can lead to death.

Gardasil Autopsy Reports

The current study, Death after Quadravalent Human Papillomavirus (HPV) Vaccination: Causal or Coincindental? examined the brain tissue of two young women who died suddenly after receiving the HPV vaccine, Gardasil. One of the young women was 19, healthy, medication free and had no previous medical history. She died in her sleep after being given the third dose of the vaccine, which elicited an apparent exacerbation of symptoms that had developed soon after the first dose.The symptoms that emerged after her first dose included: warts on her hands, fatigue, muscle weakness, tachycardia, chest pain, tingling in her extremities, irritability, confusion and memory lapses or amnesia.

The other young woman was 14 years old, had a history of migraines and was using oral contraceptives. Within two weeks of her first dose, she developed a constellation of symptoms that included exacerbation of migraines, speech problems, dizziness, weakness, inability to walk, excessive vomiting, depressed consciousness, confusion, amnesia. Two weeks after the second dose, she was found dead in the bathtub by her parents.

The original autopsies for each the young women revealed no abnormalities and no precise cause of death. With the second girl, the coroner noted cerebral edema and what is called cerebellar herniation – a condition where brain swelling pushes against lower brainstem compressing the region responsible for respiration (breathing) and heart function.  Even though histopathology was done as part of the autopsy, the coroner’s reports provided no indication of which antibodies were used for histology investigations, suggesting only general and non-specific histopathology, making it near impossible to determine if the HPV vaccine was in involved.

Advanced Immunohistochemistry

Without the appropriate immunohistochemical (IHC) examinations, using specific antibodies to tag the antigens used in the HPV vaccine, there was no way for the coroner to determine whether the HPV vaccine elicited or contributed to the deaths of these girls. Knowing this, the current researchers developed a specific IHC to examine the brain tissue and determine whether the vaccine was responsible. What they found was disturbing, but incredibly important.

The IHC from this study found evidence of autoimmune cerebral vasculitis triggered by the HPV16L1 component of the vaccine. HPV16L1particles were identified all over the cerebral vasculature including adhering to the vessel walls. They also observed an increased expression of the complement of immune markers consistent with vasculopathic syndromes. These included:

  • Excessive adhesion of T lymphocytes
  • MHC- II signaling and deposition of immunoglobulin G-immune complexes to cerebral vasculature
  • Increased MMP
  • Intense micro- and astrogliosis

Diagnosing Vasculitis

Diagnosing vasculitis is difficult both because of its rarity, especially in young, previously healthy, individuals and because the constellation of symptoms often mimic other conditions. Blood work, angiography and often a biopsy of the tissue in question are required but not always confirmatory, making this diagnosis as much about clinical expertise as testing.

Once diagnosed, the treatments include, high-dose corticosteroids and sometimes, chemotherapeutic agents.  If diagnosed, it can be treated or at least maintained. The problem, is that currently few physicians are looking at vasculitis as a possible culprit for the range of symptoms exhibited by Gardasil or Cervarix injured young women. This study suggests we should. There are however, dissenting opinions.

Dissenting Opinions and Possible Problems with the Findings

Following the publication of these findings in October 2012, the CDC convened a panel in November 2012 to review the report. The CDC panel  identified concerns with the study methods and interpretation of findings. The working group contends that:

  1. A finding of vasculitis requires evidence of inflammatory infiltrate damage within the vessel wall and that standard histopathology testing (hematoxylin and eosin- H&E stain) stain would have identified said damage. Since the H&E stain was negative, vasculitis was not evident and did not exist.
  2. Details of the authors’ histopathology methods/staining and the appropriate control data (HPV vaccine free brain tissue) were not included, are new, have not been tested and therefore, are not valid.
  3. HPV-16L1 particles are too small to identify using light microscopy, electron microscopy (EM) would have been required. The authors provided no evidence that EM was used. And again, the issue of the lack of control specimen was indicated as a flaw.
  4. Lack of information about alternative causes of death.

Rebuttal of CDC Panel Findings

Comparing apples to oranges. Neither of the two studies the CDC offers as evidence against the finding of cerebral vasculitis involves research on cerebral vasculitis. One of studies cited is a letter to the editor published in the Rheumatology journal reporting two cases of skin vasculitis, post-Gardasil vaccine; evidence that appears to support a linkage between the HPV vaccine and vasculitis in general rather than dismiss it.

The second study cited as evidence against cerebral vasculitis was the CDS’s own study, a 2009 Post Liscensure Gardasil Surveillance Report that reviewed and tabulated the Vaccine Adverse Event Reports (VAERs) data from June 2006, through December 2008. Neither cerebral vaculitis nor other forms of vasculitis was an endpoint or outcome variable evaluated in this study. Using the CDC’s Surveillance report, which neither included the very endpoints in question, nor gathered manufacturer independent data to verify claims to negate the findings cerebral vasculitis, is spurious at best, and disingenuous or worse when one considers the potential risks involved for getting this diagnosis wrong.

Technical and methodological criticisms. The technical criticisms against the cerebral vasculitis findings involve utilizing new, less well understood methods to detect the disease process versus accepted and tools and techniques. Only time and additional testing will tell whether these concerns are valid. This was a preliminary study, to reject it based on its newness and novelty, particularly when the risks are so high, seems unwarranted. Instead, additional research should be undertaken immediately to confirm or reject the claims and to validate or invalidate the methods.

No control data. This is a red herring, used against some studies when necessary and dismissed in others when it suits the critic. Other highly praised Gardasil studies, for example, find it perfectly acceptable to have no controls groups. Certainly, a control group would be ideal, but in preliminary case reports it is not necessary. The authors of the study in question address the lack of control subjects and recognize the need for additional research. It should be noted, however, that postmortem brain tissue analysis in young, healthy women is not common and it would be difficult to determine what was ‘normal’ versus abnormal. Again, rather than reject the findings of cerebral vasculitis outright, additional testing should begin to validate or invalidate these findings.

Is Cerebral Vasculitis or Vasculitis Linked to the HPV Vaccines?

At this point it is not clear, additional research is needed. However, the clinical presentation of adverse reactions appears to support cerebral and other regional vasculitides. Together with this preliminary postmortem tissue evidence, not only does the vasculitis linkage warrant additional investigation, I feel it should it be included in the diagnostic differential, particularly for the treatment refractory constellation of neurological and autoimmune symptoms so commonly reported by vaccine recipients.

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