HappehTheoryMain

 

The part of the brain used for speech processing is in a different location than originally believed, according to a US study Monday that researchers said will require a rewrite of medical texts.

Wernicke’s area, named after the German neurologist who proposed it in the late 1800s, was long believed to be at the back of the brain’s cerebral cortex, behind the auditory cortex which receives sounds.

But a review by scientists at Georgetown University Medical Center of more than 100 imaging studies has shown it is actually three centimeters closer to the front of the brain, and is in front of the auditory cortex, not behind.

“Textbooks will now have to be rewritten,” said neuroscience professor Josef Rauschecker, lead author of the study which appears in the Proceedings of the National Academy of Sciences.

“We gave old theories that have long hung a knockout punch.”

Rauschecker and colleagues based their research on 115 previous peer-reviewed studies that investigated speech perception and used brain imaging scans — either MRI (functional magnetic resonance imaging) or PET (positron emission tomography).

An analysis of the brain imaging coordinates in those studies pointed to the new location for Wernicke’s area, offering new insight for patients suffering from brain damage or stroke.

“If a patient can’t speak, or understand speech, we now have a good clue as to where damage has occurred,” said Rauschecker.

It also adds an intriguing wrinkle to the origins of language in humans and primates, who have also been shown to process audible speech in the same region of the brain.

“This finding suggests the architecture and processing between the two species is more similar than many people thought.”

Lead author Iain DeWitt, a PhD candidate in Georgetown’s Interdisciplinary Program in Neuroscience, said the study confirms what others have found since brain imaging began in earnest in the 1990s, though some debate has persisted.

“The majority of imagers, however, were reluctant to overturn a century of prior understanding on account of what was then a relatively new methodology,” he said.

“The point of our paper is to force a reconciliation between the data and theory.”

 

 

Medical regulators are drawing up new advice for more than 30,000 Britons who have received “metal-on-metal” devices because of fears that they are even more dangerous than previously thought, a Sunday Telegraph investigation has found.

Problems occur with such devices when friction between the metal ball and cup causes minuscule metal filings to break off, which can seep into the blood and cause inflammation, destroying muscle and bone.

There are also concerns that the fragments could put the nervous system, heart and lungs at risk of being slowly poisoned.

The problems have been found to affect people of all ages but studies have found young and petite women are particularly at risk.

Patients with this type of hip replacement are already supposed to undergo annual checks, with scans and blood tests if doctors  Healthcare products Regulatory Agency (MHRA) have decided the advice should go further due to concerns that the devices could cause “systemic toxicity” in the body.

The move comes as an investigation found:

  • Newly obtained research shows some hip replacements, which were withdrawn from the UK market in 2010, have far higher failure rates than had been known — of up to 50 per cent within six years.
  • Warnings from senior surgeons that although all patients given two specific implants should have been checked for metal leaks, not all have been contacted.
  • Nine legal firms are preparing compensation claims for 1,136 patients who suffered as a result of the two substandard devices.

A report from a conference of senior surgeons, held behind closed doors, describes the situation regarding all metal-on-metal hip replacements as “frightening” given the number of patients now suffering tissue reactions amid “component failure of catastrophic proportions”.

Metal-on-metal implants were introduced in the UK in the 1990s when they were promoted as offering better mobility than replacements which use a metal ball and plastic socket. They were seen as a better option for younger patients, who were likely to be more active and put more pressure on the joint.

In total, more than 40,000 patients in Britain have had them implanted. They include 10,000 who received two types of implants made by DePuy, a subsidiary of the health giant Johnson & Johnson, which were taken off the market in September 2010 because of declared “failure rates” of 12 to 13 per cent at five years.

More than 5,500 were given full hip replacements, with the rest given partial “resurfacing” operations with the devices. Now, a report on more than 500 patients, presented to the British Hip Society and seen by The Sunday Telegraph, has found failure rates of up to 50 per cent at six years for those given the full hip replacement.

Even among those given the more limited resurfacing treatment, one in four products failed within the same period, according to the study by surgeons in the North East.

Experts have not established why the DePuy models have such a high failure rate. In September 2010, the MHRA said orthopaedic surgeons should contact every patient given either a DePuy ASR or DePuy ASR XL model, to ensure they were monitored.

Any patients suffering abnormal pain or deteriorating hip function should have been offered tests to establish the levels of cobalt and chromium in their blood, and MRI or ultrasound scans to check for soft tissue reactions. If problems were found the device should be replaced, the alert said.

However, The Sunday Telegraph can disclose that the British Orthopaedic Assocation (BOA) has written to surgeons, expressing fears that not all patients who received the DePuy devices have been recalled for checks.

The letter, sent this month, says that records held by DePuy show that just over one third of patients who received the devices are recorded as having been recalled.

Professor Joe Dias, president of the BOA, said he understood that just 41 per cent of patients who received the implants were registered on this system.

He said it was possible that others had been recalled by hospitals, and undergone checks, without their details being centrally logged but that he was concerned that some had never been contacted.

The surgeon said that while private hospitals and large NHS units seemed to have been thorough in contacting patients, it was less clear whether small NHS units had done the same.

“My worry would be about cases where surgeons have retired, and no-one is following up on the patients they treated,” he said.

The implants’ manufacturers cannot contact patients directly, because they do not have access to their records.

In 2010, months before the DePuy recall, all 40,000 patients with metal-on-metal implants were told that they should undergo checks annually for at least five years.

The MHRA would not say when it would issue the new alert, or what it would say.

Stephen Cannon, a consultant orthopaedic surgeon for the Royal National Orthopaedic Hospital, said the type of damage caused by metal leakage could make replacement operations more difficult.

There was also concern that increased cobalt and chromium levels in the blood could be toxic to kidneys and, in the case of pregnant women, be passed on to the unborn child.

Experts expressed alarm that many people could remain unwittingly at risk from the products.

Peter Walsh from the patient safety charity Action against Medical Accidents said: “It is outrageous that this has been allowed to happen and that patients who are at risk from these products have not been warned.”

He said the system of regulation for medical devices required a radical shake-up, with the disclosures about the safety of hip replacements following the fiasco in which thousands of women received potentially dangerous PIP breast implants made of industrial silicone.

Massive legal action is now under way over the DePuy claims with 1,136 already represented by lawyers. Some individual compensation claims are likely reach six figures to take account for loss of earnings from patients facing repeated operations and disability, lawyers said.

A spokesman for DePuy said the company was working to provide patients with information and support. He said the company had no comment on how many patients who should have been recalled were logged by their system.

The study showing a 50 per cent failure rate was based on findings by one surgeon, and was not in line with the latest national figures, which had found a five-year revision rate of 17 per cent for the full hip replacement, he added. 

 

 Happeh Theory For The Scholar Post Index

The Nature Of The Human Body

The Spiral View Of The Human Body

 

The story this blog entry is based on describes how Australian scientists want to stop teaching of Alternative Medicine in public universities.

There is one reason and one reason only the scientists want to prevent the teaching of Alternative Medicine.

Money.

People who go to Alternative Medicine are not spending money on Western Medicine. If Western Medicine people are not getting money, how do they pay for their vacation homes, their Rolls Royce, or their child’s college tuition?

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MORE than 400 doctors, medical researchers and scientists have formed a powerful lobby group to pressure universities to close down alternative medicine degrees.

Almost one in three Australian universities now offer courses in some form of alternative therapy or complementary medicine, including traditional Chinese herbal medicine, chiropractics, homeopathy, naturopathy, reflexology and aromatherapy.

But the new group, Friends of Science in Medicine, wrote to vice-chancellors this week, warning that by giving “undeserved credibility to what in many cases would be better described as quackery” and by “failing to champion evidence-based science and medicine”, the universities are trashing their reputation as bastions of scientific rigour.
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The group, which names world-renowned biologist Sir Gustav Nossal and the creator of the cervical cancer vaccine Professor Ian Frazer among its members, is also campaigning for private health insurance providers to stop providing rebates for alternative medical treatments.

A co-founder of the group, Emeritus Professor John Dwyer, of the University of NSW, who is also a government adviser on consumer health fraud, said it was distressing that 19 universities were now offering “degrees in pseudo science”.

“It’s deplorable, but we didn’t realise how much concern there was out there for universities’ reputations until we tapped into it,” Professor Dwyer said. “We’re saying enough is enough. Taxpayers’ money should not be wasted on funding [these courses] … nor should government health insurance rebates be wasted on this nonsense.”

Professor Dwyer said it was particularly galling that such courses were growing in popularity while, at the same time, the federal government was looking at ways to get the Therapeutic Goods Administration to enforce tougher proof-of-efficacy criteria for complementary medicines, following the release of a highly critical review by the Australian National Audit Office last September.

Of particular concern to the group is the increase in chiropractic courses, following the recent announcement of a new chiropractic science degree by Central Queensland University. More than 30 scientists, doctors and community advocates wrote to the vice-chancellor and health science deans at the university voicing their concern, which laid the foundations for Friends of Science in Medicine.

The groundswell of protest from medical professionals comes after a decision in Britain that means from this year it will no longer be possible to receive a degree from a publicly-funded university in areas of alternative medicine, including homeopathy and naturopathy.

German and British medical insurance providers are also in the process of removing alternative therapies from the list of treatments they will cover.

Australia’s vice-chancellors will meet in March and Professor Dwyer said his group was aiming to get a commitment from them to endorse health courses only with evidence-based science.

The spokesman for Universities Australia said tertiary institutions were self-accrediting. “[They have] the autonomy … to ensure the quality and relevance of the courses they offer,” he said.

The Tertiary Education Quality and Standards Agency, a government body set up to regulate higher education, refused to comment.

Most health funds pay rebates for alternative therapies under top cover polices. Private Healthcare Australia did not return the Herald’s calls.

Jan 242012
 

This index contains articles demonstrating the stoopidity of scientists in some way. The results of a study may be wrong, the scientists in the study might be taking payments from a corporation, new theories being put forth might be wrong etc. Most of the links are to copies of the stories that contain no commentary on why they are examples of scientific stoopidity.

Those stories need to be commented on, but in the meantime the curious individual or the individual who is confident they can figure things out on their own, can peruse the stories to see if they already know why the stories are examples of scientific stoopidity without needing to be told.

 

Scientists R Stoopid

Uncategorized stories of scientific stoopidity.

Scientists R Stoopid To Do

Stories of scientific stoopidity that need to be commented on.

Scientists Make Mistakes

Scientists make mistakes just like everyone else.

Scientists R Wrong

Some of the things that scientists say are so obviously wrong they need no comment.

Scientists R Greedy

Scientists will lie about science for money.

Anyone Can Discover

Scientists think only they are qualified to make new discoveries. The stories in this section are examples of new scientific discoveries made by people who are not scientists.

 

The Worm View of the Human Body

The Worm View of the body is a modification to the Blob View of the body. This modification makes the Blob View of the body more closely resemble the familiar human body. The first thing to do is to show that a blob and a worm are similar. Below is a comparison picture of a worm and the computer model blob.

In the Blob View of the body, it was said the blob could be described as a fluid filled sack. A worm can also be described as a fluid filled sack. The blob was described as shapeless and deformable. This means the blob can take on any shape. A worm is confined to a generally cylindrical shape. The difference in physical outer shape does not change the fact that both a blob and a worm are fluid filled sacks. A worm and a blob are, for the most part, identical.

There must be some difference between a worm and a blob. Otherwise they would both be called worms, or blobs. What is the basis for classifying a worm and a blob as two completely different things?

A worm is a long cylindrical creature with a hole at either end. One hole is the mouth for ingesting dirt, the other hole is for excreting waste. The tube or cylinder connecting the mouth to the waste exit is called an alimentary canal. The alimentary canal contains various organs that extract nutrition from the food. Below is a cutaway drawing of an earth worm.

The mouth is the elliptical opening on the right side of the drawing. The cylindrical or rectangular appearing end on the left is the waste end of the alimentary canal.

A worm is really nothing more than a blob that has been punctured so that there are two exit holes in the skin of the blob, and a tube connecting the puncture holes. The blob in the picture below has been punctured vertically. The blob could be punctured across any part of it’s surface. The only requirement is that a tube transversing the entire blob is created with an opening at either end.

Now that the blob has been punctured, it physically resembles a worm except for the shape. Because the blob is shapeless and deformable, it can change into the shape of a worm without affecting the function of the blob.

The spherically shaped blob on the left was compressed horizontally so that it assumes the shape in the middle picture. The shape of the blob in the center picture generally resembles the elliptically shaped real life worm on the far right. Although it is not visible, the mouth / alimentary canal / waste exit combination of the worm is oriented in the same vertical direction as the tube puncturing the blob.

The Blob View of the body said the human body could be described as a shapeless, deformable blob. The demonstration above describes how a blob is like a worm. If a human being is like a blob, and a blob is like a worm, then the human body must be like a worm.
The Worm View of the body says that a worm can be used as a theoretical model to provide insight into the real life behavior of the human body. The picture below compares a worm to a mature human body.

At first glance, there is no resemblance at all between a worm and a human being. We need to look past the surface appearance to a more basic level.

At the most basic level, all complex living creatures need three things to sustain life. A mouth, a digestive tube or alimentary canal, and a waste exit. We know from the previous page that a worm has all three of these requirements. A human being also has a mouth, an alimentary canal, and a waste exit. Therefore, on a basic level, a worm and a human being are the same.

The alimentary canal of a worm is a simple straight cylinder. In the human being, the alimentary canal is not a simple cylinder. The alimentary canal of the human being twists and turns and changes shape and size. The picture below shows the complete human alimentary canal. The alimentary canal starts at the mouth, then travels down to the stomach and intestines, where it crosses back and forth until it turns downwards to the anus, or waste outlet.

In general, both the alimentary canal of the worm and the human being can be described as an elongated and distorted torus shape. A torus is a fancy name for a doughnut. Below is a picture of a torus. Beginning on the left, there is a front view, a side view in the center, and an angled view of a torus on the right.

All that needs to be done to make the doughnut shape look like an alimentary canal is to stretch the torus out lengthwise as shown below.

As you can see in the comparison picture below, the elongated torus and the worm are generally the same shape.

The torus and the worm both have a hollow tube in the center with an exit at each end. For the purposes of this discussion, the worm will be treated as an idealized perfect torus shape like the computer model above. Even though the alimentary canal of the human being twists and turns, it will also be treated as an idealized perfect torus shape.
The Worm View of the body can be used to demonstrate the effects on the body of practices such as yoga or martial arts. Yoga, martial arts, etc., are designed to lift the person to a higher plane of existence. Part of this process is to physically develop the body so that it is strong and healthy.

A strong and healthy body is a prerequisite for the mind to be healthy because of the definition of the Blob View of the body. The Blob View of the body says the entire blob is one connected piece. Anything that happens to one part of the blob must affect the entire blob. If the body is physically weak, the mind must also have some weakness according to the Blob View of the body.

One way to describe these physical and mental improvements is to say the experienced person has gained a deeper control of their body. A normal person would be described as controlling the surface layer of their body. The picture below is of a human being in the overhead view. The normal person would control the blue area using this model.

According to the Blob View of the body, as the person gained control of areas of the torso closer to the center of the body, they would simultaneously be activating areas of the brain that are closer to the center of the body. The red circle above includes the center of the body and the center of the brain.

One of the real world benefits of martial arts or yoga, etc, is to increase the amount of the alimentary canal the person can consciously control or sense. This fact can be used to construct a simple model to demonstrate how the process of improving the human body takes place.

An outline of the torus shape / worm, which represents the man’s mouth / alimentary canal / waste exit combination, is overlaid on the path between the mouth and the anus on the human body below.

The next picture demonstrates how the normal person would appear using this theoretical model. The mouth, throat, anus, and rectum areas are colored in red, signifying that these areas are under the man’s conscious control.

As the person progressed in their practice, they would slowly gain more and more control of the mouth / alimentary canal / waste exit combination. The picture below shows the throat and part of the lower intestines colored in blue to indicate they can now be consciously controlled. This might be a person who had practiced martial arts for 3 to 5 years.

This process continues as long as the person continues to practice whatever physical discipline they are involved in. Some people will experience these changes to their body without the need for special exercises.

The picture below shows the next stage of the process. This could be said to indicate ten to fifteen years of practice.

The green areas signify that the man can now consciously control the alimentary canal traveling through the chest area, as well as the rest of the lower intestines, and part of the upper intestines.

The pinnacle of achievement would be when a person gained control of the entire alimentary canal. The pink color fills in the remainder of the torus shape, indicating the man has gained conscious control of his entire alimentary canal, from the mouth to the anus.

The implication of the picture above is that, as the person gains conscious control of the alimentary canal closer towards the center of the body, they also gain control of the internal organs, etc., that surround the alimentary canal. The performance and health of the internal organs will improve as a result of this conscious internal awareness of them.

As the level of conscious control of the alimentary canal changes, a person can feel sensations as if the bottom of the mouth or the anus has extended to the current level where conscious control of the alimentary canal ends. Here is the example picture of a person with complete control of the alimentary canal.

The current example will use the mouth. A normal person’s mouth would be described as ending at the back of the throat. That level would be at the lower boundary of the red area on the mouth of the model above.

In the picture below, there is a mouth located to the side of the body at each further level of attainment. The mouths are meant to emphasize the movement of the back of the mouth. The back of the mouth coincides with the moving boundary line indicating what part of the alimentary canal the person can currently control.

At the first level of attainment, the bottom of the mouth could feel like it was at the base of the throat at the bottom of the blue area. At the next level of attainment, the back of the mouth could feel like it was at the bottom of the rib cage at the bottom of the green area. At the last stage of achievement, the bottom of the mouth could feel as if it was located in the center of the stomach.
The description of the back of mouth moving is not just a theoretical idea. In real life, a person will really feel sensations within their body as if this is happening. When a normal person moves their mouth, they might feel as if the muscles of the inside of the mouth run from the lips to the back of the throat. The red lines on the picture below highlight the described area.

Simultaneously with the back of the mouth moving down into the alimentary canal, the person can feel as if their mouth opening is enlarging. The picture below demonstrates this idea.

The mouth opening now runs from the top of the forehead to the bottom of the chin. The yellow circle in the stomach is where the bottom of the mouth, or the bottom of the anus would be located.

The description of the mouth opening enlarging would look something like a wild animal growling. When a gorilla becomes angry, it opens it’s mouth very wide and roars. The gorilla can open it’s mouth so wide because he is opening his mouth from the center of his stomach as shown in the picture above. Instead of just the small muscles of the jaw and mouth pulling on the mouth opening, the muscles of his torso are pulling the mouth opening wide.

The previous picture leads to another property of the Worm View of the body that is very useful. The picture below will help demonstrate this property. The picture on the right is the previous picture showing the base of the mouth and the anus as being located at the yellow circle in the stomach. The picture on the left is the same situation from the front view.

The claim that the mouth and anus are both anchored at the stomach imply that the mouth must balance the anus. If the stomach is the center of the body, and the mouth and the anus are at either end, the forces the mouth and anus generate must be balanced to hold the center at it’s location in the stomach.

If the forces the mouth and the anus generate are unbalanced, then the center would move from the stomach to a different part of the body. If the mouth was stronger, the center would move upwards. If the anus was stronger, the center would move downwards.

This idea of a proper center connecting the back of the mouth and the back of the anus can be used for diagnosing the health of a human being. The observer would inspect a person to see if the center point has moved from it’s proper position in the stomach. A skilled person can see the movement of the person’s center from outside of their body quite easily. If the center point has moved, the person’s health will be negatively affected in some way.

 

The video linked below is located at YouTube.

The Worm View of the Human Body Video 01

A webpage duplicate of the video follows for those that prefer reading to viewing a video.

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The Worm View of the Human Body

Darwin’s theory of evolution says that human beings evolved from a single cell floating in the ocean. The single cell evolved into a fish, an amphibian, a bird, a reptile, an insect, a mammal, and then a human being.

According to Happeh Theory, the modern human body retains characteristics of all of the creatures on the path of evolution. The modern human body shows characteristics of a single cell, a fish, an amphibian, a bird, a reptile, an insect and mammals.

That means that the human body must also display the characteristics of a worm,

because a worm is one of the creatures on the path of evolution.

A worm is basically a cylinder with a hollow tube in the center penetrating it lengthwise as shown in this picture. One end of the hollow tube is the mouth.

The other end of the tube is the waste disposal opening.

The structure of the body of a worm provides corroboration for the claim that the human body retains the characteristics of all creatures on the path of evolution. A human being also has a hollow tube penetrating the torso lengthwise as shown in this picture.

One end of the tube is the mouth,

while the other end of the tube is the waste disposal opening.

This picture shows what the Worm View of the Human Body looks like.

The cylindrical body of the worm is superimposed over the torso with the mouth of the worm aligned on the mouth of the human being,

and the waste disposal hole of the human being aligned on the waste disposal hole of the worm.

The Worm View of the Human Body is similar to the Single Cylinder View of the Human Body. According to the The Single Cylinder View of the Human Body, the rib cage, pelvic bones and associated musculature, can behave like a cylinder that is located on the human body as shown in this picture.

This cylinder encloses the torso the same way the cylindrical body of the worm encloses the torso.

Comparison of the Worm View of the body and the Single Cylinder View of the body,

suggests that the Worm View of the body is an improvement on the Single Cylinder View of the body.

While both the Worm View of the body and the Single Cylinder View of the body consist of a vertically oriented cylinder,

the cylinder of the Worm View of the body has a tube penetrating the center of the cylinder lengthwise,

with holes at either end.

This addition or improvement to the Single Cylinder View of the body means that the Worm View of the body can be used to model more behaviors of the human body, and more complicated behaviors of the human body, than the Single Cylinder View of the body is capable of modeling.

The Worm View of the Human Body is superior to the Single Cylinder View of the Human Body, because the construction of the Worm View of the Human Body more closely resembles the construction of the real human body, than the construction of the Single Cylinder View of the Human Body does.


 

This video is part 02 of the series on The Wave View of the Human Body

It was stated in the first video of this series that the construction and behavior of the human body is influenced by waves. This is a picture of a wave on an instrument called an oscilloscope.

This three view picture of the human body,

was used to prove the statement that the human body is influenced by waves. The arms, legs and torso of the human body, all have a wave shape to them, as shown by the red lines.

This video will present more information that proves the human body is influenced by waves.

The main organ of the body that keeps a human being alive is the heart. The heart pumps blood throughout the body every second of a person’s life.

How is blood pumped in and out of the heart? In what is called the Diastolic Phase,

the heart relaxes so that blood can enter into and fill the heart. Then, in what is called the Systolic Phase,

the heart contracts which forces the blood in the heart back out into the body.

The heart beats constantly which means that the heart is always alternating between the Diastolic phase and the Systolic phase. This picture shows multiple alternating instances of the heart in the Diastolic Phase and the Systolic Phase.

In simple language, the picture shows a series of alternating large and small human hearts.

What does the overall shape of the top or bottom of the alternating hearts look like? A line following the countours of the alternating hearts is drawn above and below the hearts in this picture,

to make it clear what that shape is.

The overall shape at the top and the bottom of the alternating hearts is a wave. Here is a picture comparing the lines at the top and bottom of the hearts to the wave that was shown on the oscilloscope.

They both look similar.

Every time the heart beats, it sends waves throughout the entire body. This phenomenon is more proof that the statement “The human body is influenced by waves”, is a true statement.

 

(  This is old material being provided for archival purposes, and in case it contains anything newer material on the same subject does not cover. )

According to The Double Testicle View of the Human Body, the behavior of the human body can be modeled by two large testicles. A testicle has an elliptical shape. For that reason, The Double Testicle View of the Human Body can also be called The Double Ellipse View of the human body. The words testicle and ellipse are also used interchangeable in the rest of the article.

The picture below shows the demonstration human body with two large ellipses to either side of it. Each ellipse represents one of the testicles of the Double Testicle View of the Human Body.

The two large testicles are located on the body approximately as shown below.

The next picture is the profile view. It takes careful examination to see the face sticking out from the front of the ellipse. The toes can be seen relatively easily.

The next picture is an overhead view looking down on the man with the two testicles superimposed on his body. The top of the head and front of the face are at the top of the picture.

The next picture is an overhead picture also. In this picture, the two testicles have been made partially transparent so the way in which they surround the body can be seen.

The ellipses in the demonstration picture are a particular size. When using The Double Testicle View of the Human Body to demonstrate or discuss the human body, it is allowable to change the size of the ellipses to emphasize some point.

If the diameter of either or both ellipses is increased or decreased, they would still fit the definition of The Double Testicle View of the Human Body.

 

According to Happeh Theory, masturbation can make a human being blind and crippled. The news story that is reprinted below discusses how scientists found that people using Viagra are going blind.

It is not the drug Viagra that is making them blind. Viagra is allowing the men to engage in too much sexual activity. Viagra is said to give a man an erection for four hours. If a man took Viagra repeatedly, which would allow him to masturbate excessively, the blindness these scientists are linking to Viagra would also be linked to masturbation.

Just like Happeh Theory says.

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Federal health officials are examining rare reports of blindness among some men using the impotence drug Viagra.

The Food and Drug Administration still is investigating, but has no evidence yet that the drug is to blame, said spokeswoman Susan Cruzan.

This type of blindness is called NAION, or non-arteritic anterior ischemic optic neuropathy. It can occur in men who are diabetic or have heart disease, the same conditions that can cause impotence and thus lead to Viagra use.

The
FDA has 50 reports of the blindness. Viagra has been taken by more than 23 million men worldwide.

“We take this seriously,” said FDA’s Cruzan.

On its Web site, Viagra manufacturer Pfizer Inc., states: “The most common side effects of Viagra are headache, facial flushing, and upset stomach. Less common are bluish or blurred vision, or being sensitive to light. These may occur for a short time.” That language had been available before the current inquiry.

Pfizer spokesman Daniel Watts confirmed Friday that the drugmaker was in discussions with the FDA about adding a disclosure to Viagra’s label to say that in rare cases, men taking Viagra had developed blindness. However, he said there is no proof that Viagra caused the blindness. He said that men who take Viagra often have high blood pressure and high cholesterol, which are also associated with the conditions that can cause blindness.

FDA is working with Pfizer to determine what, if any, information about the condition should be added to the drug’s label. The story was first reported by CBS News.

Viagra was approved by the government in 1998. It may aid in the treatment of enlarged hearts that can result from high blood pressure, tests on animals indicate.

Viagra, approved to treat erectile dysfunction, should not be used by men with heart conditions whose doctors have warned them not to have sex. Also, patients taking drugs that contain nitrates have been warned not to take Viagra because of sudden, unsafe drops in blood pressure.

The drug’s label also warns of erections lasting longer than four hours, painful erections lasting longer than six hours, headache, flushed skin and vision problems.

Pfizer Inc., the New York-based maker of Viagra, said in its most recent quarterly filing with the
Securities and Exchange Commission that sales of the drug rose 5 percent — to $438 million in the first quarter of the year. Pfizer also said at the time that Viagra had a 68 percent worldwide market share.

STORY FROM CBS NEWS BELOW _ MORE DETAIL

Federal health investigators are looking into reports that some men who used Viagra may have suffered a new and very serious side effect — blindness.

Twenty-three million men worldwide have used Viagra. A very small number of them are going blind after taking normal doses. And CBS News has learned from the FDA that it is urgently meeting about it with experts and Pfizer.

Jimmy Grant started using Viagra in 1998, when he was 57. At first, he felt pressure in his temples and saw color changes in his vision.

“I noticed the symptoms probably within 45 minutes to an hour,” he told CBS News correspondent Sharyl Attkisson.

Soon, he went blind in his right eye. Doctors didn’t make a connection to Viagra.

“After your loss of vision, did you continue taking doses?” Attkisson asked.

“On occasions, I did,” he said. “And then in March 2000 after taking Viagra I experienced loss of sight — partial loss of sight in my left eye.”

With both eyes damaged, a friend found an article on the Internet about Viagra and blindness, and Grant put two-and-two together.

“What convinced me that Viagra did it was what Dr. Pomeranz had in his report.”

That’s Dr. Howard Pomeranz, an eye specialist who appears to be the first doctor to make a connection in one of his patients back in ’98. To him, it made sense that Viagra — which alters blood flow in key parts of the body — could also affect circulation to the optic nerve.

“And so I thought, well, in both of these situations, blood flow is being altered, so maybe there is a connection between the two,” said the University of Minnesota neuro-ophthalmologist.

He published his patient’s case looking for feedback. By 2001, he had five cases to report to the FDA and Pfizer, the makers of Viagra. Slowly, more reports trickled in.

“So they certainly are aware of this possible side effect of their medication,” Pomeranz said.

The FDA tells CBS News it’s looking at about 50 reported cases of vision loss and, while no direct link has been proven, an FDA medical supervisor says “We’re very concerned. This issue is front and center, it’s a priority. We know people need to know as promptly as possible.”

Pfizer told us its Viagra studies show no report of vision loss and say there is no more evidence of vision loss in men taking Viagra than those who don’t. However Pfizer confirmed it in in discussions with the FDA to update the labels to reflect the rare occurrences.

Jimmy Grant is now spending retirement in a way he never imagined: living with his 83-year-old mother, suing Pfizer, and sorry he ever tried Viagra.

“I’ve pretty much accepted that my eyesight is not going to come back. But I’ve also pretty much accepted that Viagra done it,” he said.

The FDA says it’s monitoring adverse event reports for the similar drugs in the same class as well.

A review of 103 Viagra clinical trials involving 13,000
patients found no reports of non-arteritic anterior ischemic optic neuropathy (NAION). Outside of clinical trials, Viagra has been used by more than 23 million men worldwide over the past seven years and reports of visual field loss due to NAION are extremely rare.

There is no evidence showing that NAION occurred more frequently in men taking Viagra than men of similar age and health who did not take Viagra.

NAION is the most common acute optic nerve disease in adults over age 50 and it shares a number of common risk factors with erectile dysfunction: age over 50, high blood pressure, high cholesterol, diabetes. Most of the reported cases in which NAION has occurred in men taking Viagra have involved patients with underlying anatomic or vascular risk factors associated with the development of NAION. This makes it impossible to determine whether these events are caused by the patient’s underlying vascular risk factors, anatomical defects, Viagra or a combination of these factors — or to other factors.

Pfizer is in discussions with the Food and Drug Administration to update the Viagra label to reflect these rare ocular occurrences. Viagra has a strong safety profile and remains an effective medication that benefits millions of patients.

© 2011 Happeh Theory Suffusion theme by Sayontan Sinha

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