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Sunday, April 12, 2009

So Botox isn’t just a pretty face

CLEVELAND, April 12, 2009 – NYT

Dr Mark Stillman, the director of the Centre for Headache and Pain at the Cleveland Clinic, has a treatment for people with frequent migraines: he injects Botox around the head and neck.

Dr Andrew Blitzer, the director of the Centre for Voice and Swallowing Disorders at St. Luke’s-Roosevelt Hospital Centre in Manhattan, has an antidote for speech impediments caused by vocal cord problems: he injects Botox into the larynx.

Dr Fredric Brandt, a dermatologist in Manhattan and Coral Gables, Fla., has a novel procedure for oily skin and skin redness. You guessed it: Botox.

Over the last decade, Botox has become a synonym for the eradication of wrinkles, a kind of shorthand for the entire enterprise of cosmetic medicine. But now, with the popularisation of new medical uses, therapeutic applications of the drug are poised to outstrip the cosmetic treatment in both revenue and prominence.

In the hunt to discover the next blockbuster medical use for Botox, doctors have injected it experimentally into muscles and glands all over the body, making it medicine’s answer to duct tape.

According to recent medical journals, physicians have used it to treat chewing problems, swallowing problems, pelvic muscle spasms, drooling, hair loss, anal fissures and pain from missing limbs.

“We see it as a molecule that keeps on giving. As we understand it more, it gives us new ideas of how to use it,” says Dr Mitchell F. Brin, a neurologist who is the chief scientific officer for Botox at Allergan, the drug’s maker.

No other therapeutic agent “has so many demonstrated uses,” he says.

But some health advocates worry that doctors are widely adopting novel uses for Botox before federal guidance and rigorous clinical studies have established safe and effective dosages for the new treatments.

“It’s trial and error with a nerve poison,” says Dr Sidney M. Wolfe, the director of the health research group at Public Citizen, a consumer advocacy group. Last year, the group petitioned the Food and Drug Administration to require a warning label for injectable toxins.

Botox is a purified form of botulinum toxin, a nerve poison produced by the bacteria that cause botulism, a disease that paralyses muscles and can be fatal. Injections of Botox act like minuscule poison darts that temporarily blunt chemical nerve signals to certain muscles or glands, reducing their activity.

The FDA. has approved Botox to treat four problems: eye muscle disorders, neck muscle disorders, excessive sweating – and that deadly age giveaway, eyebrow furrows. But Allergan, a $14.5 billion specialty pharmaceutical company, owns or has applied for patents on more than 90 uses for the drug.

Dr Brin of Allergan says Botox has a long safety track record – backed by 30 years of favourable research, studies on 11,000 people worldwide and 17 million treatments in the United States since 1994.

“That safety profile has enabled us to continue to explore the product in deeper parts of the body and in more novel areas,” Dr Brin says. Allergan does not promote unapproved uses of the drug, he says.

Botox was developed in the 1970s by Dr Alan Scott, an ophthalmologist in San Francisco who was searching for a cure for crossed eyes. He theorised that minute doses of a nerve poison used to weaken the muscles that pull crossed eyes inward could treat the malady, and he experimented with a variety of paralytic agents.

Then a biochemist who had isolated and purified a strain of botulinum toxin for potential military use as a biological weapon sent Dr Scott a sample. It worked.

Dr Scott named the new drug Oculinum. In 1989, the FDA. approved it to treat crossed eyes and twitching eyelids. Allergan bought Oculinum in 1991 for about $9 million, rebranding it Botox. When David E. I. Pyott became chief executive of the company in 1998, Botox had $90 million in annual sales. Last year, sales topped $1 billion.

“Nobody at Allergan understood how big a gold mine they were sitting on,” Pyott says.

Drug companies often rely on multiple products to fill their pipelines. But at Allergan, Botox became a virtual pipeline in and of itself after the arrival of Pyott, who recognised that it was a medication that could be serially reincarnated for other applications.

Doctors, who are permitted to use approved drugs in unapproved ways as they deem appropriate, were already using Botox off-label at the time on body parts other than eye muscles. Some physicians reported that patients had unexpected side effects – fewer headaches, for example, or smoother skin – after they had Botox.

Pyott invested heavily in expanding in-house research and encouraged doctors to formalise their anecdotal observations with published research.

He also recognised that some Americans would be willing to pay handsomely for injections that tempered wrinkles. To prove the efficacy of the drug, the company sponsored clinical trials to use Botox for cosmetic medical purposes and for other muscle disorders.

Over the last nine years, the FDA has approved Botox to treat neck muscle spasms and to hinder excessive sweating. The agency also approved the same drug, under the name Botox Cosmetic, to smooth forehead wrinkles.

Last year, Botox had worldwide sales of $1.3 billion, divided about equally between cosmetic and medical uses. Among botulinum toxins, Botox has an 83 per cent share of the market, Allergan said.

But, with competing toxins set to enter the American market, Allergan has positioned Botox for other medical uses. Pyott says he expects therapeutic sales of the drug to soon eclipse sales of Botox Cosmetic.

Health insurers sometimes cover medical uses of Botox; a treatment for a clenched jaw might cost $1,000 every three months, for example. But for cosmetic treatments, which dipped slightly at the end of last year, consumers must pay cash.

“The therapeutic will end up being bigger than the cosmetic even if the economy recovers because there are some big unmet medical needs there,” Pyott says.

In the next few months, the company is expecting federal approval to market the drug for stroke victims suffering from limb tightness or spasms.

Later this year, Allergan plans to seek approval to market the drug for chronic migraine headaches, Pyott said. He also said the company eventually plans to seek FDA approval to market Botox for benign enlarged prostate.

But many doctors are not waiting for federal sanction to inject Botox for these and other disorders. While Allergan doesn’t break down Botox sales, Gary Nachman, an analyst at Leerink Swann, an investment bank, estimates that perhaps as much as half of Botox sales already come from off-label uses.

“It’s the magic bullet,” says Nachman.

Botox is so widely adopted in medicine – and ingrained in popular culture – that some doctors don’t think that novel uses are experiments.

Several years ago, Dr Kamran Jafri, a facial surgeon in Manhattan, started injecting Botox just under the skin of the face, a technique that he says reduces pore size, blotchiness and oily skin.

“Dosing is by trial and error,” Dr Jafri says. “I don’t think it’s experimental because it’s a treatment I’ve been doing a lot and it’s been working.”

Such ad hoc uses of Botox are perfectly legal for doctors. But some medical professionals are concerned that doctors are experimenting with and adopting Botox therapy before clinical trials and government approval have established safe doses for new indications – and without definitive proof that the new treatments work.

While life-threatening complications following use of Botox and other botulinum toxins are rare, a few people have died after they were treated. In some cases, the toxin has spread from the injection site, causing serious swallowing and breathing problems. For example, several children with cerebral palsy died after receiving large doses in their limbs.

“It is possible to over-inject. This is a poison,” says Dr Frederick Burgess, the chief of anaesthesia at the VA Medical Centre in Providence, R.I. “Things can go wrong. It is rare, but it happens.”

Last year, Public Citizen petitioned the FDA, asking for a stronger warning on botulinum toxins that would emphasise the risk of diffusion from the injection site and the need for patients to seek immediate medical care for swallowing or breathing difficulties.

The Canadian health authority instituted such a labelling change earlier this year.

Pyott of Allergan says that there have been a few serious problems following Botox injections – but not necessarily directly caused by the drug. Some patients had serious illnesses prior to treatment, he said.

“Physicians have experimented with higher and higher doses,” Pyott says. “Like any drug, if you take too much, you can have side effects.”

The FDA is reviewing the safety of botulinum toxins, according to an agency press release. Last year, the agency also postponed approval of a new toxin called Dysport for use in neck muscle problems. The FDA asked the manufacturer to first develop a plan for communicating the risk of the drug to doctors and patients.

On Monday, the FDA is due to issue a decision on the cosmetic version of Dysport, called Reloxin.

Johnson & Johnson is also developing an anti-wrinkle injection called PureTox.

But industry analysts predicted that the FDA would postpone approving any new botulinum toxins until regulators have finalised a stronger warning label for all of the brands.

When Pyott arrived at Allergan, it specialised in eye-care pharmaceuticals. Over the last decade, he has turned it into the house that Botox built, expanding credibility for the drug in various medical specialties by buying complementary businesses.

To solidify Allergan’s dominance in appearance medicine, for example, the company spent $3.2 billion in 2006 to acquire Inamed, a leading maker of skin-plumping injections and breast implants. In preparation for the planned introduction of Botox as a treatment for headaches, overactive bladder and enlarged prostates, the company has also established itself in neurology and urology by developing or marketing other specialty drugs, Pyott says.

The possibility of lucrative new uses for Botox has not gone unnoticed. After rumours of a possible merger with GlaxoSmithKline last month, Allergan stock rose almost 24 per cent over the course of two days, to $48.95; it now trades at $47.47. Both companies declined to comment on merger rumours.

“This is a bad time to sell because they are not going to get rewarded for all of the wonderful stuff in the pipeline,” says Ronny Gal, an analyst at Sanford C. Bernstein. “I would stay independent for a couple of years.”

Gal says sales of Botox could double within the next five to seven years, provided that the FDA approves new major medical uses. One million people or more might seek Botox injections for chronic headaches, while the audience for benign enlarged prostate would be “practically every man over the age of 75,” Gal says.

Pyott has a master plan, meanwhile, to expand the Botox franchise even further. The company is developing new iterations of the drug intended to treat specific targets, such as pain receptors, without weakening muscles.

Allergan also owns or has applied for patents on dozens of other uses for its toxin, a move to pre-empt competitors from marketing their products for expanded uses.

“I feel a little bit like I am sitting with a beautiful vessel inside the harbour but I forgot to give you the map to where our mines are,” Pyott says of the Botox patents that he said were filed in different countries. “There could be a big bang when you hit one of our patents.”

But Gal, the analyst, devoted his Christmas vacation to unearthing about 90 patent applications worldwide by Allergan. These included Botox for sinus headache, fibromyalgia pain, ulcers, inner ear disorders and uterine problems as well as appearance treatments like “buttock deformity.”

Nevertheless, there are still a few ailments that Botox does not claim to solve. Botox doesn’t work on stuttering, for example, because it involves too many parts of the anatomy – including the lips, the larynx and the tongue, says Dr Brin of Allergan.

“Stuttering is too complicated,” Dr Brin says a little wistfully. “It didn’t pan out.”

Wednesday, April 8, 2009

Wristband to alert sun over-exposure

Tue, 07 Apr 2009 17:31:30 GMT | PressTV

The increased rate of skin cancer among sunbathers prompts scientists to create a wristband to warn user against maximum sun exposure.

Excessive sun exposure is reported as the main trigger for DNA changes leading to melanoma, the most malignant type of skin cancer in 70 percent of sufferers.

The new bracelet-style product, which will enter the market in the upcoming months, turns pink when the sunbather is in danger of getting a sunburn.

The chemicals inside the band react to UV rays, changing in color from yellow to pink. Scientists believe the UV-driven reaction with the dye in the band acts as an "intelligent ink".

The band also notifies the user when it is necessary to reapply sunscreen. Like the skin, this band absorbs sunscreen and gradually turns brown when it is time to reapply sunscreen.

BRAF gene mutation has been recently identified as the first event in the cascade of genetic changes leading to melanoma.

Researchers are optimistic that by identifying the gene responsible for this cancer they can lower the incidence of sun over-exposure and in turn lower the rate of skin cancer and its complications.

Broccoli sprouts cut gastric cancer risk

Tue, 07 Apr 2009 17:46:42 GMT | PressTV

Broccoli sprouts protect the stomach against a bacterial infection which causes conditions such as gastritis, ulcers and stomach cancer.

According to a study published in Cancer Prevention Research, eating 2 1/2 ounces of three-day-old broccoli sprouts every day for at least two months reduces the levels of H. pylori infection but does not prevent it.

H. pylori levels are reported to return to pre-treatment levels eight weeks after the individual stops eating the sprouts.

H. pylori is a known carcinogen and a major risk factor for stomach cancer; reducing the number of this microorganism can therefore lower the subsequent risk of cancer.

Sulforaphane, a compound with proven anticancer and antibiotic properties commonly found in broccoli, stimulates the body particularly the gastrointestinal tract to produce enzymes that protect the body against cell damage and inflammation.

Compared to broccoli heads, the sprouts are a richer source of sulforaphane.

Scientists concluded that a diet rich in broccoli sprouts can lower the risk of various types of cancer including esophageal, bladder, skin, lung, and gastric.

Sunday, April 5, 2009

'Rocket fuel' found in US baby formula

Sun, 05 Apr 2009 14:34:13 GMT | PressTV

While the contamination of baby formula is not unheard of, this is the first time that rocket fuel-tainted formula has been found in the US.

The Centers for Disease Control and Prevention reported trace levels of perchlorate -- a chemical used as the main ingredient in solid rocket fuel, fireworks, and road flares -- in certain brands of baby formula.

Authorities declined from saying which brands had been tested.

The report revealed that the cow milk-based formula contained more perchlorate than soymilk- and lactose-free cow milk-based formulas.

While the Environmental Protection Agency reports perchlorate levels are within the safe range, the report has caused public health concerns about the damage the compound can cause to the function of the thyroid.

Perchlorate can inhibit the thyroid gland's iodine uptake, interfering with fetal development, the study published in the Journal of Exposure Science and Environmental Epidemiology reports.

Reports indicating the presence of perchlorate in the water supplies of 35 states particularly near defense and aerospace sites have aggravated the condition.

Many believe American babies are at an increased risk, as they are not only exposed to the compound in baby formula but also in tap water.

Scientists believe to counteract the effects of perchlorate iodine must be added to formula and urge the government to set a stricter perchlorate health advisory level.

Male contraceptives to hit markets soon

Sun, 05 Apr 2009 17:22:04 GMT | PressTV

The discovery of a new gene has raised hopes of producing a male contraceptive pill in the near future, to reduce unwanted pregnancies.

According to a study published in the American Journal of Human Genetics, mutations in the CATSPER1 gene, responsible for producing the protein needed for normal sperm movement, is linked with male infertility.

"Identification of targets such as the CATSPER1 gene that are involved in the fertility process and are specific for potentially minimizing the side effects of a drug targeting the protein's function, provide new targets for a pharmacological male contraceptive," the leader of the research team, Michael Hildebrand said.

Men treated with the antibodies designed to target the CATSPER1 protein were reported to have reduced fertility. As the sperm of these men were unable to fertilize eggs, scientists believe these antibiotics can be used to produce a male contraceptive.

They hope to use these findings to develop new infertility treatments.

Saturday, April 4, 2009

Human body regenerates heart cells: Study

Fri, 03 Apr 2009 19:25:29 GMT | PressTV

A study using Carbon-14 dating method has shown that human body can regenerate heart cells at a rate of about one percent a year.

Conducted by Sweden's Karolinska Institute researchers, the study has raised hopes for the artificial stimulation of the renewal process and reducing the need for transplants in future.

"It would be a way to try and help the heart to some self-help rather than transplanting new cells," Jonas Frisen of Sweden's Karolinska Institute said in a telephone interview.

"Taking advantage of the heart's own capacity to generate new cells either using pharmaceutical compounds or, if it is possible, by exercise or any other environmental factor."

Heart cells stop dividing early in life and although there are stem cells in the heart, its muscle just forms scar tissue and never fully regenerates.

Scientists also found that the rate at which our body regenerates heart cells slows by time reducing to half a percent a year by the age of 75, Reuters reported.

"If you exchange cells at this rate it means that even if you live a very long life you will not have exchanged more than 50 percent of your cells," said Frisen.

"So at any given time your heart is a mosaic of cells you carry with you from birth and cells that that have been added later to replace cells that have been lost during life."

According to the study reported in the journal Science, the heart's ability to regenerate cells could help find out whether people are susceptible to heart disease or not.

"We are interested in studying whether some heart diseases could potentially be caused by too low an ability to replace heart cells," said Frisen.

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