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The Evidence of Stoping Hair Loss by Laser Comb is Thin

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Popular hand-held laser device LaserComb might revive follicles for some men. Maybe.

Americans spend billions on hair-care products each year, a remarkable investment for a part of the body with no real function. We clean it, nourish it and style it — and we definitely mourn its loss.
…
Lots of products and procedures promise to restore thinning or disappearing hair. One especially intriguing option is the HairMax LaserComb, a hand-held laser device that supposedly revives hair follicles. Hailed on TV news programs as a potential “cure for baldness,” the device received FDA clearance for men in 2007. Unlike drugs, most medical devices can be approved without rigorous testing. A company must merely persuade the Food and Drug Administration that the new device is “substantially equivalent” to other products already on the market. In this case, the makers of the LaserComb told the agency that their product was roughly as safe and effective as a wide range of other laser devices, including a gadget intended to kill lice. They also claimed to be in the same league as the Evans Vacuum Cap, an early 20th century hair-growth contraption that’s pretty much what it sounds like.

The LaserComb is sold online and through the SkyMall catalog for about $500.

Users are instructed to slowly move the comb back and forth through their remaining hair for 10 to 15 minutes at a time, three days a week.

The claims
According to the HairMax website, “90% of HairMax users notice positive benefits starting in as little as 8 weeks. These results include: increased hair growth, cessation of hair loss, faster growing hair, more manageability and more vibrant color.”

David Michaels, the managing director of Lexington International, the company behind the LaserComb, says it works by “transferring light energy to cellular energy” in the follicles. The device can’t restore hair to a bald spot, he says, but it can make any remaining hair grow “faster, thicker, heavier and stronger.”

The bottom line
Lasers can undoubtedly encourage hair growth, says Dr. Marc Avram, a clinical associate professor of dermatology at Weill Cornell Medical College in New York City.

In fact, a small percentage of people who undergo laser hair removal end up with more hair than they had to start with. As Avram and colleagues noted in a 2007 issue of the Journal of Cosmetic and Laser Therapy, many hair-loss centers offer treatment with low-level laser devices, and some patients really do seem to benefit. Nobody knows why hair responds to lasers, he explains, although it’s possible that the beams somehow encourage blood flow to the follicles.

Still, according to Avram, there’s no good evidence that the LaserComb works any better than more-established treatments such as the prescription medications Rogaine or Propecia. For his patients who are unwilling or unable to use the medications, he says that the device could be worth a try. The LaserComb is safe, he says, and it just might help. “But I set low expectations for it.”

Avram recently tested the HairMax LaserComb on a handful of patients in his office over six months. (Contrary to claims made for the LaserComb, Avram says, it takes at least six months to see real results from any hair-loss treatment.)

“In 20% of the subjects, it seemed to maybe have an effect” on the appearance of hair, Avram says. The study hasn’t been published yet, and it didn’t include a control group for the sake of comparison. Avram readily admits his study “isn’t definitive,” but he hopes it might encourage more research in the future.

By contrast, Rogaine and Propecia have already been tested in multiple high-quality studies and have been shown to stop hair loss in 80% to 90% of patients, Avram says.

Uncertainty aside, the LaserComb has clearly captured the public‘s imagination. Patients ask about it “all the time,” says Dr. Paradi Mirmirani, a dermatologist with the Kaiser Permanente Vallejo Medical Center and a member of the North American Hair Research Society. Mirmirani says the device could potentially stimulate hair growth. “But I don’t have any evidence. If patients want to spend $500 on this device, it’s their choice. But I wouldn’t recommend it. They should save it for something that we know actually works.”

Last May, the FDA issued a warning letter against Lexington International for illegally marketing the device to women when it had been officially cleared only for men. The HairMax website now says that the device is intended for men only, but recorded messages for callers on hold to customer service still say that it “works equally well on both men and women” and that “anyone of any age, male or female, can benefit.”

Michaels says the company has asked the FDA for approval to market the device to women and expects a decision soon.

Is there a consumer product you’d like the Healthy Skeptic to examine? E-mail the details to health@latimes.com.

Sources: Los Angles Times

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New Drug Makers: Goats

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They have four legs, fuzzy faces and udders full of milk. To the uninitiated, they look like dairy goats. To GTC Biotherapeutics Inc, they’re  cutting-edge drug-making machines.

The goats being raised on a farm in central Massachusetts are genetically engineered to make a human protein in their milk that prevents dangerous blood clots from forming. The company extracts the protein and turns it into a medicine that fights strokes, pulmonary embolisms and other life-threatening conditions.

GTC has asked the Food and Drug Administration to clear the drug, called ATryn. An expert panel voted overwhelmingly on Friday that it is safe and effective, putting it on the verge of becoming the first drug from a genetically engineered animal to be approved in the US. The agency is expected to make a final decision in February, said the Los Angeles Times.

If approved, the drug would be followed by hundreds of others made from milk produced by genetically engineered goats, cows, rabbits and other animals. Other products in the pipeline are designed to treat people with haemophilia, respiratory diseases and debilitating swollen tissues.

“As soon as we were able to make genetically engineered animals, this was an obvious thing to do,” said James Murray, a geneticist and professor of animal science at UC Davis. “It’s totally cut-and-paste. This is kindergarten stuff with molecular scissors.”

The biotechnology industry is rooting for ATryn. The FDA’s endorsement would signal to Americans that they have nothing to fear from the futuristic technology—and suggest that the millions they’ve invested in the technology could soon begin to pay off.

If the drug is approved, “it takes a big question mark off the table in terms of products that are developed from this technology,” said Samir Singh, president of US operations for Pharming Group, which is developing medicines using milk from genetically engineered cows and rabbits.

The public has had misgivings about eating food from genetically modified animals, and some vocal critics of such technology say the wariness could extend to medicines. “I think many people are going to have the same revulsion,” said Jaydee Hanson, a policy analyst at the Center for Food Safety, a Washington advocacy group that opposes genetic manipulation of food and animals.

For scientists, the appeal is obvious. Many drugs are now synthesized in bioreactors by bacteria or Chinese hamster ovary cells, and they require extensive processing to be suitable for humans. Genetically engineering animals is a better alternative for producing proteins, which form the basis of all biological drugs. “We’re taking advantage of the fact that the mammary gland was designed by nature to make proteins,” said Tom Newberry, GTC’s vice president for government relations.

Sources: The Times Of India

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FDA Approves Two New Stevia-Based Sweeteners

The FDA approved two versions of a new zero-calorie sweetener developed by the Coca-Cola Company and PepsiCo.

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Cargill, which is marketing the sweetener Truvia from Coca-Cola, received notification from the FDA that it had no objection to the product, calling it “generally recognized as safe.”

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PepsiCo said it also had received a similar letter and the same “generally recognized as safe” designation for its sweetener, PureVia.

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Both products use rebiana, an extract from the stevia …plant.

Sources: New York Times December 17, 2008

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Osteoporosis Drugs May Lead to Cancer

Merck’s popular osteoporosis drug Fosamax and other similar drugs may carry a risk for esophageal cancer, a Food and Drug Administration official said .

Diane Wysowski of the FDA’s division of drug risk asessment said researchers should check into potential links between so called bisphosphonate drugs and cancer. In a letter in Thursday’s New England Journal of Medicine, Wysowski said since the initial marketing of Fosamax, known generically as alendronate, in 1995, the FDA has received 23 reports in which patients developed esophageal tumors.

Typically, two years lapsed between the start of the drug and the development of esophageal cancer. Eight patients died, she reported. In Europe and Japan, 21 cases involving Fosamax have been logged, with another six instances where Procter & Gamble’s Actonel or risedronate and Didronel or etidronate. Six of those people died.

Esophagitis, which is an inflammation of the lining of the tube carrying food to the stomach, is already known to be a side effect of the drugs.

Sources: The Times Of India

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New Drugs to Battle Multiple Sclerosis

Several new drugs that treat inflammation caused by the disease are showing promise, although serious side effects are still an issue.

……….….CLICK & SEE

Multiple sclerosis remains a cruel medical mystery. It strikes in the prime of life and runs an unpredictable course that can end in total disability. Scientists are a long way from halting the disease entirely, but several promising drugs are in late-phase clinical trials and experts anticipate better lives for patients in the near future.

“We will see many new drugs on the market and many new options for patients,” says Dr. Diego Centonze, a neurologist at Tor Vergata University in Rome, who is running clinical trials for three new experimental compounds, including one called fingolimod that is the first oral MS drug to move to Phase 3 clinical trials.

In the early 1990s, there were no Food and Drug Administration-approved therapies for MS on the market. Today, there are at least half a dozen, and Centonze expects as many as eight or nine by 2010.

But there are still many challenges, says Dr. Ari Green, assistant director of the multiple sclerosis center at UC San Francisco, which also is running drug company-sponsored trials. None of the approved drugs is ideal, and each of the new experimental drugs has significant adverse side effects.

MS is an autoimmune disease: The body’s immune system attacks some of its own tissues. The common form, known as relapsing-remitting, begins when disease-fighting lymphocytes launch an attack on the brain and spinal cord. These relapses cause short-term inflammation and symptoms such as numbness, but eventually lead to a progressive decline of the nervous system.

The less common form of MS — primary progressive — doesn’t manifest itself with acute attacks, although patients still exhibit neurodegeneration, leading to fatigue, pain, problems with walking and balance, dizziness and bladder and bowel dysfunction.

Currently approved drugs primarily work by reducing the activity of lymphocytes or reducing their ability to travel from the blood into the nervous system. Some of the new ones do that too — while others function in different ways.

The first drugs to gain approval in the mid-1990s were interferon beta-1b (Betaseron), interferon beta-1a (Avonex or Rebif) and glatiramer acetate (Copaxone). Because they have minimal side effects (such as flu-like symptoms) they are used as a first line of defense. But they are only moderately effective, says Dr. Rhonda Voskuhl, director of the UCLA multiple sclerosis program. Patients “fail them, and then move on” to more powerful drugs such as natalizumab (Tysabri) and mitroxantrone.

Mitroxantrone, approved in 2000, is a chemotherapeutic drug that suppresses the immune system and can lead to leukemia or heart damage.

Natalizumab (Tysabri), which received accelerated FDA approval in 2004 and is considered the most effective drug available today, was taken off the market in February 2005 after three patients in clinical trials developed progressive multifocal leukoencephalopathy, a fatal viral disease. After an FDA review, it has been available under a special program in which patients are closely monitored for opportunistic infections.

On the horizon
There’s clearly a lot of room for improvement, which is one reason why doctors are excited about options on the horizon.

Fingolimod, originally developed to prevent organ rejection in transplant patients, blocks a signal that allows T-cell lymphocytes to cross into the brain. At the American Academy of Neurology meeting this year, researchers reported that 173 patients with a relapsing form of MS showed a decline in the relapse rate over 36 months from 0.31 relapses per year to 0.20, a 30% decrease in their relapse rate when they took fingolimod. In just six months, the number of patients with brain lesions decreased from an average of 2.2 per patient when taking the placebo down to 1.29. In addition, after 36 months, brain scans revealed that 89% of patients had no evidence of inflammation.

Fingolimod is promising not only for effectiveness but because it comes in pill form, Centonze says. “For patients that must receive injections every other day or every single day, the quality of life is really affected. Taking pills can change this.”

Another compound on the horizon is alemtuzumab (Campath), a monoclonal antibody designed and FDA-approved for fighting leukemia. In a trial of 334 patients published in October in the New England Journal of Medicine, researchers reported that the drug could reduce the relapse rate in early-stage MS patients by two-thirds relative to the standard MS drug interferon beta-1a.

UCSF’s Green says the findings are impressive because this is the first MS trial to compare a new drug to an approved compound rather than a placebo and yet “it still had a remarkable effect on reducing disease activity.”

Rituximab, an antibody that was designed for treating rheumatoid arthritis, is also being studied, in a clinical trial headquartered at UCSF. Rituximab is directed at the immune system’s B cells, rather than T cells that have been targeted by MS researchers since the 1970s.

Biology of MS
In February, a team led by Dr. Stephen Hauser of UCSF reported in the New England Journal of Medicine that in a 48-week trial of 104 patients, rituximab halved the number of patients experiencing relapses relative to a placebo. “It’s led to a whole new understanding of the biology of MS,” Green says. “There are now a ton of potential therapies that are going to be B-cell directed.”

But the downside of taking powerful modulators of the immune system are their serious side effects, including making patients more susceptible to infections and other chronic diseases. Two patients died after taking fingolimod, one with a brain infection and the other with shingles.

And in the alemtuzumab trial published in October, researchers reported that one-quarter of the patients developed an autoimmune disease attacking the thyroid and three developed an autoimmune disease of the blood platelets.

“Drugs like this are toxic,” Voskuhl says. “It’s a hard sell to people who are very young to expose them to drugs that have dramatic side effects.”

A larger problem with the current slate of therapeutics is that they address only the inflammation side of the disease. “But we now know for sure that neurodegeneration is not just caused by inflammation,” Centonze says.

As excited as he is about the burgeoning treatment options, he says, “Before judging the real quality of these drugs, you must treat many, many patients for several years.”
Sources:Los Angles Times

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