Prescriptions Blog: F.D.A. Approves Drug for an Advanced Skin Cancer

The first drug for an advanced form of the most common type of skin cancer won approval from the Food and Drug Administration on Monday.

The drug, Erivedge, made by Genentech, was approved for adults with basal cell carcinoma that has spread elsewhere in the body or those who are not candidates for the surgery or radiation ordinarily used to treat the disease.

Basal cell carcinoma is usually a slow-growing and painless form of cancer that develops on skin frequently exposed to the sun, like on the face, according to the F.D.A. If confined to a small location on the skin, it is generally considered curable by surgery and radiation treatment.

In rare cases, however, the tumors cannot be treated that way. In some cases, known as locally advanced disease, they invade nearby tissues and can become disfiguring. In other cases, they become metastatic, spreading elsewhere in the body.

The F.D.A. said in a news release that the approval was based on an analysis of 96 patients in a clinical trial with locally advanced or metastatic basal cell carcinoma. Some 30 percent of the patients with metastatic disease experienced a partial shrinkage of their tumors. For the patients with locally advanced disease, 43 percent experienced either a complete or partial shrinkage.

There was no control group getting a placebo in the trial, and the F.D.A. emphasized that it had approved the drug after a speedy review and before its March 8 deadline.

The F.D.A. has been under pressure from some patient advocates who contend that it demands too much data to approve drugs for cancer, potentially allowing people to die. Other advocates, however, say the F.D.A. needs to maintain a high bar to make sure drugs are truly safe and effective and do not offer false hopes.

Those differences came to a head over the agency’s decision in November to revoke the approval for another Genentech drug, Avastin, as a treatment for breast cancer.

The wholesale price of Erivedge will be $7,500 a month, or about $75,000 for the 10-month course of treatment that was typical in the clinical trial, according to a Genentech spokeswoman.

The company did not mention the price in its news release announcing the approval. That seems to be a fairly common practice among drug companies, perhaps to deflect attention from the costs of medicines.

Erivedge can cause birth defects or stillbirths, the F.D.A. said. The most common side effects included muscle spasms, hair loss, nausea, diarrhea, and problems with tasting.

Known generically as vismodegib, Erivedge is a capsule taken once a day. Genentech developed Erivedge with help from Curis, a small company in Lexington, Mass., that will receive a $10 million payment for the approval and a small royalty on sales of the drug.

Curis shares, which have been rising in the last few months, were down 7 percent to $4.80 as of about 3:30 p.m. Monday.

Erivedge works to inhibit the so-called Hedgehog signaling pathway by binding to a protein called Smoothened. The Hedgehog pathway is important in regulating growth and development early in life but gets less active in adulthood, according to Genentech. But in basal cell carcinoma signaling in this pathway is frequently abnormal.

On Friday, another company, Infinity Pharmaceuticals, stopped a midstage trial of a Hedgehog pathway inhibitor it was developing to treat pancreatic cancer after patients getting the drug had a shorter survival time than those getting a placebo. But the company said it would continue to test the drug, saridegib, for other types of cancer.

Source: http://feeds.nytimes.com/click.phdo?i=1e1619d49e7f455fc4f08b23f390b8aa

Thrush In Men And Women – The Underlying Causes

The most important thing you need to know about thrush, candida and yeast infections is that they are all only symptoms of a bigger problem.

Many people carry yeast in and on their bodies without even knowing. It is a natural organism, known as candida albicans, and is normally found in the intestines, vagina, mouth and skin, where ‘friendly’ bacteria help to keep yeast levels low. However, when this balance is disrupted and the yeast is allowed to grow unchecked, it causes havoc in the body.

The vagina is one of the areas most likely to be affected by yeast infections and these are more commonly referred to as thrush. Although the vagina is generally too acidic for yeast to grow out of control, it is sensitive to small changes and can easily become an ideal environment for yeast to flourish. Too much, and the vaginal tissues become irritated, leading to the itching and burning sensations, which are the typical symptoms of thrush.

Most people view thrush, candida and yeast infections as minor problems, exclusive to women. But this is totally incorrect. As many as 75% of humans will be afflicted with one of the many types of this irritation at some point in our lives, whether it be in the form of nappy rash, the white coating on the cheeks and tongue of oral thrush, an itchy weeping sweat rash in a skin fold, or a slight soreness around the tip of the penis which men ignore and can then pass on to their female partners during sex..

For some people, the yeast can proliferate and leech into the bloodstream infesting other parts of the body and releasing toxins which, in addition to the usual vaginal thrush, can also be responsible for causing cystitis, eczema, blotchy skin, dryness, itching, oral thrush, sinus problems, constipation, diarrhea, restless sleep, bloating, lack of energy, mood swings, cravings for sweet food, food allergies and many more.

These yeast spores can remain dormant for years and then suddenly flare up resulting in an outbreak of any of the above. Many health professionals persist in handing out prescriptions that treat only the symptoms and this can result in a return of the infections in ever more virulent forms until they become resistant to the available drugs.

This means that it is down to you to take responsibility for your health and to start investigating the causes. Isolating what it is that worsens the symptoms for you personally.

Repeated doses of antibiotics are a well-known trigger, as is a diet rich in yeast, fungus, sugar and refined, processed produce. The physiological effects of stress are also a major factor in providing an environment which encourages the overgrowth of candida.

Unfortunately, antibiotics are often used to ‘cure’ the problems mentioned previously as being caused by candida and yeast infections so, again, an ever repeating cycle of problem/medication/problem is set in motion.

If you search the internet, you will discover all sorts of natural ‘cures’, but so many of these are replicating the problems with the pharmaceutical method in that they treat the symptoms of thrush, candida and yeast infections, not the root cause.

Tight Foreskins and Penile Balanitis

In most male babies, the foreskin and the glans of the penis develop as one structure but, as the infant becomes a child, separation of the two parts takes place naturally. Sometimes a small amount of bleeding can accompany this event but, in the majority of cases, it passes unnoticed.

By the time the child hits puberty, foreskin and glans have become two discrete entities and only about 1% of 17 year olds are still unable to retract their prepuce, often due to scarring through a medical condition like diabetes.

However, modern thinking into personal hygiene advises mothers to encourage their young sons to pull back their foreskins to clean underneath them at ever younger ages. For children born in the latter part of the last century, some healthcare policies even advocated that mothers should actually force the tight forskin back themselves.

Penile balanitis is the reason for this focus on foreskin cleanliness. The natural juices of the penis produce a build up of white residue called smegma and it should be washed away carefully every day with warm soapy water.

If it is allowed to collect for any length of time under the foreskin, it can become infected, forming a smelly, cheesy-like substance. This prevents the foreskin from being able to retract and so the glans itself becomes red, sore and inflamed, making it painful to urinate.

In some cases, penile balanitis in young boys can also be due to an allergy to soap or a skin condition like eczema or psoriasis, in which case an emollient or aqueous cream can be substituted.

A visit to the doctor should be made as soon as possible to ascertain the cause and obtain antibiotics to clear up the infection.

Whilst a lot of three year olds will be able to accomplish the retraction and cleaning of their own foreskin, many are not and forcing it to retract before proper separation has occurred can cause scarring on the delicate inner lining. This damage can result in the inside of the prepuce becoming fixed to the shaft or glans of the penis by the scar tissue and then retraction becomes impossible.

This condition is known as phimosis and, in days gone by, the young man may well have found himself the subject of a circumcision. However, advances in science have developed a much less invasive operation called a preputioplasty where a small vertical cut is made in the tight ring of skin at the end of the foreskin which is restricting the movement and then stitched together horizontally to make the opening looser.

As a side note, researchers have also noted that masturbation techniques can also be linked to problems with scarring. Boys who lie face-down and rub themselves against the mattress have been known to give themselves a mild phimosis but, when encouraged to turn over and revert to a technique which more closely simulates the back and forth movement of sexual intercourse, the condition resolves itself without need for medical intervention.

Whilst talking about boys and tight forskins, paraphimosis should also be mentioned. This is a condition where, after retraction, the foreskin gets stuck behind the glans and it becomes impossible to return it to its normal position. If the problem continues for more than an hour or if there are signs that blood flow is being impeded, the situation should be treated as a medical emergency. To prevent this, boys should be educated about the need to return the prepuce to its flaccid position over the glans after it has been retracted for washing.

In all cases, retraction and replacement should only be done by the child himself when he has shown that separation has occurred and it is possible to achieve.

Pearly Penile Papules – Not Thrush In Men

Pearly Penile Papules Treatments are difficult to find because it is not known for sure exactly what causes these bumps to appear on the male penis. Diet, poor hygiene, penile balanitis and masturbation have all been implicated and then eliminated as causes – but the tiny skin tags are quite common and present in around 20% of the population.

Known medically as Hirsuties papillaris genitalis, these tiny white or flesh-colored lumps measure 0.5-3mm across and usually appear in one or several rows around the circumference of the glans penis – the ridge at the base of the ‘helmet’.

Contrary to popular belief, they are not sexually transmitted and do not affect health or sexual performance.

However, their presence can cause embarrassment, psychological discomfort and self-esteem issues and, whilst some men just learn to live with them, others are determined to find effective penile papules treatments and eradicate the problem.

Common home remedies including toothpaste, honey, vitamins A and E, retinol A, iodine, cider vinegar and oatmeal, along with traditional wart treatments such as freezing have proved ineffective but most healthcare professionals have been reluctant to recommend surgery for aesthetic reasons as most techniques have had limited degrees of success.

Some men do elect to undergo penile papules treatments such as ablation by carbon dioxide laser, electro-dissection with curretage or excisional surgery. The penis is numbed with an anaesthetic cream before the treatment and, providing no complications arise – inflammation and infection, hematoma, scarring issues, swelling, bruising, and numbness – all these procedures can be performed without a hospital stay.

However, technological advances in lasers have resulted in promising outcomes using newer fractional ablative approaches.

Source: John Edwards has life-threatening heart condition


(CNN) — A federal judge disclosed Friday that former presidential candidate John Edwards has a life-threatening heart condition, a court source confirmed to CNN.

Edwards had sought a delay in his criminal corruption trial, scheduled to begin this month.

Attorneys and the federal judge met in a North Carolina courtroom Friday afternoon for a status hearing regarding the pending trial of Edwards, a former U.S. senator.

Edwards appeared at Friday’s hearing. His lawyers had made the motion for a delay under seal, but some of its details were publicly revealed by the judge in the open hearing.

The criminal trial has been delayed until at least March 26, according to the court source. Judge Catherine Eagles said she has been in contact with Edwards’ cardiologist, who recommended a postponement, saying Edwards is scheduled to undergo surgery next month.

Edwards has to provide the court with a written medical update by February 28, according to court records.

One legal expert, Marcellus McRae, a trial lawyer and former federal prosecutor, said he doubted that Edwards’ illness would influence a jury verdict.

“Edwards’s illness may prompt the public, including potential jurors, to view him in a more sympathetic light. However, it is doubtful that this will have any impact on the outcome of his trial,” McRae said. “Given the nature of the charges, his physical condition is of no relevance and he will have in theory recovered by the time the case went to trial in March in any event.”

Edwards’ attorneys asked in December to delay his criminal trial, saying he had an unspecified medical issue.

Edwards is charged with six felony and misdemeanor counts related to donations to and payments from his failed 2008 presidential campaign. He is accused of conspiracy, issuing false statements and violating campaign contribution laws. He denies any wrongdoing.

Edwards’ wife, Elizabeth, died of cancer in December 2010. The couple had separated that year, shortly after Edwards admitted that he had fathered a daughter with Rielle Hunter, who was hired to make documentary videos for his campaign for the 2008 Democratic presidential nomination.

March 26 is also when a North Carolina civil trial is scheduled to start in Hunter’s invasion-of-privacy lawsuit against Andrew Young, an Edwards aide in the 2008 presidential campaign.

Hunter is suing Young to reclaim materials that she says belong to her, including an alleged sex tape that involves Edwards.

Hunter’s lawsuit claims that the tape was made in or about September 2006 and that she worked with a political action committee for Edwards’ campaign between about July 2006 and December 2006.

InSession’s Jessica Thill contributed to this report.


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Source: http://rss.cnn.com/~r/rss/cnn_health/~3/hPpFNKp6fYg/index.html

Can Masturbation Cause Thrush In Men

A question that comes up again and again in my search terms for this site is can masturbation cause thrush?

And the answer is, yes it can – if you don’t observe proper hygiene afterwards.

can masturbation cause thrush-in-menAn old myth goes that one hundred men were interviewed about whether they masturbated, or not. It is said that eighty five per cent admitted that they did, and the other fifteen were liars. Listen, it’s yours, so you do what you want with it, but take care of it because it’s delicate and it doesn’t take much rough usage to cause cracks or cuts on the foreskin. Men with a foreskin need to pay more attention to their personal hygiene. It should be retracted and the whole area cleaned at least once every day, for health reasons as well as standard personal grooming. Whether you have a sexual partner, masturbate, or neither, you should pay attention to the inside surface of the foreskin. It is possible that even men who do not pursue personal or partnered sexual relief will still experience erection during sleep, so all men with an intact foreskin should examine it.

Can Masturbation Cause Thrush In Men

Making love frequently with a partner, re-establishing sexual contact after a period of abstinence, dry masturbation, using saliva as a lubricant, or simple nocturnal erections can all cause fissures in the internal surface of the foreskin. They usually take the form of purple parallel lines radiating outwards from the head of the penis to the external rim of the inside of the foreskin. They can be actual surface cracks, or sub-dermal splits. You’ll know if they are actual splits as they sting quite severely. The sub-dermal fissures only hurt when the foreskin is retracted when dry. If they are surface cracks, clean it often – but without soap or other wash products as they only make it worse. Just use warm water, and if swelling or infection set in, see a doctor immediately.

They can be caused by fungal growth from thrush, even if you are not in contact with a sexual partner. Heavy or prolonged courses of antibiotics, or excessive use of oral steroids for conditions such as asthma can create oral thrush quite easily, and using saliva as a masturbatory lubricant will often transfer the condition to the penis. You will usually have a persistent itch around the foreskin as a first sign, and the inside of the foreskin where it’s attached to the head of the penis (the Glans) will be bright pink or red even if there are no fissures present. You can confirm the presence of thrush in your system by looking at the inside of your throat in a mirror. If you have white patches on either side of the throat walls, strange patterns in the skin of the surface of the tongue, or what looks like small pieces of chewed white nuts stuck in the folds of the throat lining, you need to see a doctor for an antifungal treatment.

However, you should also address the possibility that this manifestation in both mouth and penis could stem from a systemic Candida infection that started elsewhere in the body and investigate an anti-Candida diet if the problem recurs.

Just using saliva as a lubricant in masturbation, or not washing the whole area with the foreskin drawn back after ejaculation whether saliva has been used or not can also cause irritation, even without a fungal infection. This is due to enzyme action. Enzymes are contained within saliva as a part of your digestive process. They are also present in sperm. The sperm is like a tadpole torpedo carrying a payload of DNA to the egg. On contact, the sperm breaks open its warhead, and releases enzymes to eat a hole in the surface of the egg to allow it to deliver its payload. If saliva or sperm is left around the head of the penis after either masturbation or partner sex, and trapped underneath a foreskin, the enzymes will tend to begin to act on the surface of the Glans, and the internal surface of the foreskin.

The Glans is pretty resilient, as is evident from the way it becomes desensitized after circumcision, but the internal skin of the foreskin is as delicate as any other skin kept moist. The enzyme action can cause it to thin and lose some of its elastic structure. This in turn will cause it to tighten, and can encourage tearing when stretching it back over the Glans without care.

Fissures can appear even without sexual activity. Most men experience erections in their sleep at some point during the night, even if unaware of them. The foreskin and Glans having been rubbed on the sheets with movement during sleep will be absolutely dry. This can cause the foreskin to stretch violently, and the sub-dermal fissures can easily result.

Whether sub-dermal, or open on the surface, a good hygiene routine will ensure that at worst the condition is a mild and temporary affliction. If there is any sign of oozing, severe redness and inflammation or severe pain, don’t mess around, consult a doctor immediately. There’s no need for embarrassment, yours is unlikely to be the first they’ve ever seen.

As I said at the beginning, it’s yours, you only get one, look after it.

Thrush In Men

thrush-in-menMany people believe that yeast infections are a woman’s problem but thrush in men is far more common than is universally realised.

Up to 75% of humans will be afflicted with one of the many types of this irritation during their lifetime, whether it be in the form of nappy rash, the white coating on the cheeks and tongue of oral thrush, an itchy weeping sweat rash in a skin fold, or a slight soreness around the tip of the penis which men ignore and can then pass on to their female partners during sex, only to have it passed back to them a few weeks later in a vicious circle of re-infection.

Symptoms of Thrush In Men

There are several symptoms of thrush or yeast infection in men:

penile balanitis – where the penis becomes sore and red (from the Greek meaning inflammation of the acorn);

cuts on the foreskin – a regular problem which occurs in this delicate tissue if saliva or sperm is left around the head of the penis or trapped under the foreskin after either masturbation or intercourse.  These substances contain enzymes which can cause a reaction in the elastic structure of that  sensitive skin making it tighten which, in turn can encourage tearing if it is stretched back over the Glans with less than proper care.

genital or regular psoriasis – these patches of angry inflamed skin can occur anywhere on the body.

bad breath and a filmy white coating on the inside of the mouth.

a sweat rash in a fold of skin in the groin, arm pit or between folds of flesh in the overweight.

Whilst these are often treated individually, they can actually be part of a much larger problem.

Many people carry yeast in and on their bodies without even knowing. It is a natural organism, known as candida albicans, and is normally found in the digestive tract, vagina, mouth, skin and bloodstream. Its very short lifespan can be measured in hours or, at most, days and, providing you do not keep feeding it with the sugary substances it loves, the body’s natural eco-system keeps its numbers under control.

Causes of Thrush In Men

A form of symbient, its major function is to act as a third line of defence to keep the body’s blood sugar levels down to avoid diabetes, blindness or death. Whilst the body usually achieves this through stimulating the production of insulin in the pancreas and androgens from the adrenal glands, the failure of these defences triggers the proliferation of the Candida population to soak up any excess glucose.

Long term proliferation is only possible when sugary food is regularly available, as can occur when blood sugar levels are always raised due to insulin resistance – usually because too much fat has been consumed.

For some people, the yeast can proliferate and leech into the bloodstream infesting other parts of the body and releasing toxins which, in addition to the usual symptoms of thrush, can also be responsible for causing cystitis, sinus problems, constipation, diarrhea, restless sleep, bloating, lack of energy, mood swings, cravings for sweet food, food allergies and many more.

Many health professionals persist in handing out prescriptions that treat only the symptoms and this can result in a return of the infections in ever more virulent forms that become resistant to even the strongest drugs.

Repeated doses of antibiotics are a well-known trigger, along with a diet that contains large quantities of yeast, fungus, sugar and refined, processed produce. The physiological effects of stress also make a large contribution towards providing an environment which encourages candida overgrowth.

If you search the internet, you will discover all sorts of natural ‘cures’ for thrush in men, but so many of these serve only to replicate the problems with the pharmaceutical method in that they treat the symptoms of thrush in men, not the root cause.

At the end of the day, you need to make a lifestyle choice and properly address the issues behind your susceptibility to a yeast infection.

Thrush in men can be controlled if you take responsibility for your health and start investigating the causes to identify what makes things worse for you personally.

thrush in men